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Clinical Trial Results:
A Randomized, Controlled, Multicenter, Open Label Study with Blinded Assessment of the Efficacy of the Humanized Anti-IL-23p19 Risankizumab Compared to FUMADERM® in Subjects with Moderate to Severe Plaque Psoriasis Who are Naïve to and Candidates for Systemic Therapy

Summary
EudraCT number	2016-003718-28
Trial protocol	DE
Global end of trial date	06 Jul 2018

Results information
Results version number	v2(current)
This version publication date	18 Dec 2019
First version publication date	13 Jul 2019
Other versions	v1
Version creation reason	Correction of full data set number discrepancy

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

M16-178

ISRCTN number

US NCT number

NCT03255382

WHO universal trial number (UTN)

Sponsor organisation name

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation address

AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB

Public contact

Global Medical Services, AbbVie , 001 800-633-9110,

Scientific contact

David Williams, MD, MPH, AbbVie, david.a.williams@abbvie.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

06 Jul 2018

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

06 Jul 2018

Was the trial ended prematurely?

Main objective of the trial

The objective of this study is to compare the efficacy and safety of subcutaneous (SC) risankizumab and oral FUMADERM® provided as study medication in subjects with moderate to severe plaque psoriasis who are naïve to and candidates for systemic therapy.

Protection of trial subjects

Subject and/or parent or legal guardian read and understood the information provided about the study and gave written permission.

Background therapy

Evidence for comparator

Actual start date of recruitment

22 Aug 2017

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 120

Worldwide total number of subjects

120

EEA total number of subjects

120

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

113

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Intent-to-treat (ITT) analysis set included all participants enrolled in the study (N = 120). Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 117).

Screening details

A total of 120 participants were enrolled and included in the ITT population; 3 randomized participants discontinued prior to receiving any study drug and were excluded from the safety population.

Period 1 title

Overall Trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Fumaderm

Arm description

Participants randomized to receive open-label Fumaderm 30 mg administered as a tablet orally once daily from Week 0 to Week 2, then up to 240 mg, 3 times daily from Week 3 to Week 24 if PASI90 is not achieved and if tolerability allows.

Arm type

Active comparator

Investigational medicinal product name

Fumaderm

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Fumaderm tablet administered orally

Risankizumab

Arm description

Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.

Arm type

Experimental

Investigational medicinal product name

Risankizumab

Investigational medicinal product code

Other name

ABBV-066, BI 655066

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Risankizumab administered by subcutaneous (SC) injection

Number of subjects in period 1	Fumaderm	Risankizumab
Started	60	60
Completed	47	60
Not completed	13	0
Not specified	6	-
Adverse event	3	-
Withdrawal by Subject	2	-
Lost to follow-up	2	-

Baseline characteristics

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Reporting group title

Fumaderm

Reporting group description

Reporting group title

Risankizumab

Reporting group description

Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.

Reporting group values	Fumaderm	Risankizumab	Total
Number of subjects	60	60	120
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	42.5 ( 12.71 )	42.0 ( 13.75 )	-
Gender categorical
Units: Subjects
Female	22	27	49
Male	38	33	71
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	1	0	1
Not Hispanic or Latino	59	60	119
Unknown or Not Reported	0	0	0
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0
Asian	0	1	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	60	59	119
More than one race	0	0	0
Unknown or Not Reported	0	0	0

End points

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Reporting group title

Fumaderm

Reporting group description

Reporting group title

Risankizumab

Reporting group description

Participants randomized to receive open-label risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.

Primary: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24

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End point title

Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24

End point description

The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.

End point type

Primary

End point timeframe

Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[1]	60 ^[2]
Units: Percentage of Participants
number (not applicable)	10.0	83.3

Notes
[1] - Intent to Treat (ITT) analysis set: all participants who were randomized.
[2] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

73.3

Confidence interval

level

95%

sides

2-sided

lower limit

61.3

upper limit

85.3

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4

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End point title

Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) I PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 4

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[3]	60 ^[4]
Units: Percentage of Participants
number (not applicable)	6.7	53.3

Notes
[3] - ITT analysis set
[4] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Risankizumab v Fumaderm

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

46.8

Confidence interval

level

95%

sides

2-sided

lower limit

32.8

upper limit

60.8

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8

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End point title

Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 8

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[5]	60 ^[6]
Units: Percentage of Participants
number (not applicable)	28.3	91.7

Notes
[5] - ITT analysis set
[6] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

63.4

Confidence interval

level

95%

sides

2-sided

lower limit

50.2

upper limit

76.6

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12

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End point title

Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 12

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[7]	60 ^[8]
Units: Percentage of Participants
number (not applicable)	46.7	100

Notes
[7] - ITT analysis set
[8] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

53.1

Confidence interval

level

95%

sides

2-sided

lower limit

40.4

upper limit

65.7

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16

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End point title

Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PAS150 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) I PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[9]	60 ^[10]
Units: Percentage of Participants
number (not applicable)	60.0	100

Notes
[9] - ITT analysis set
[10] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

39.6

Confidence interval

level

95%

sides

2-sided

lower limit

27.3

upper limit

51.9

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20

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End point title

Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 20

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[11]	60 ^[12]
Units: Percentage of Participants
number (not applicable)	63.3	100

Notes
[11] - ITT analysis set
[12] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

36.3

Confidence interval

level

95%

sides

2-sided

lower limit

24.1

upper limit

48.5

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24

Top of page

End point title

Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[13]	60 ^[14]
Units: Percentage of Participants
number (not applicable)	53.3	100

Notes
[13] - ITT analysis set
[14] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

46.4

Confidence interval

level

95%

sides

2-sided

lower limit

33.7

upper limit

Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4

Top of page

End point title

Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 4

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[15]	60 ^[16]
Units: Percentage of Participants
number (not applicable)	3.3	13.3

Notes
[15] - ITT analysis set
[16] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.047

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

9.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

19.7

Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8

Top of page

End point title

Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PAS175 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) I PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 8

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[17]	60 ^[18]
Units: Percentage of Participants
number (not applicable)	8.3	75.0

Notes
[17] - ITT analysis set
[18] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

66.6

Confidence interval

level

95%

sides

2-sided

lower limit

53.8

upper limit

79.5

Secondary: Percentage of Participants Achieving 75% Improvement in PAST Score (PAS175) at Week 12

Top of page

End point title

Percentage of Participants Achieving 75% Improvement in PAST Score (PAS175) at Week 12

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PAST score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 12

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[19]	60 ^[20]
Units: Percentage of Participants
number (not applicable)	20.0	86.7

Notes
[19] - ITT analysis set
[20] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

66.6

Confidence interval

level

95%

sides

2-sided

lower limit

53.3

upper limit

79.9

Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16

Top of page

End point title

Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[21]	60 ^[22]
Units: Percentage of Participants
number (not applicable)	26.7	93.3

Notes
[21] - ITT analysis set
[22] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

66.6

Confidence interval

level

95%

sides

2-sided

lower limit

53.8

upper limit

79.5

Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20

Top of page

End point title

Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 20

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[23]	60 ^[24]
Units: Percentage of Participants
number (not applicable)	38.3	95.0

Notes
[23] - ITT analysis set
[24] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

56.5

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24

Top of page

End point title

Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PAS175 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[25]	60 ^[26]
Units: Percentage of Participants
number (not applicable)	33.3	98.3

Notes
[25] - ITT analysis set
[26] - ITT analysis set

Statistical Analysis 1

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other ^[27]

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

64.8

Confidence interval

level

95%

sides

2-sided

lower limit

52.5

upper limit

77.2

Notes
[27] - P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4

Top of page

End point title

Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 4

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[28]	60 ^[29]
Units: Percentage of Participants
number (not applicable)	0	1.7

Notes
[28] - ITT analysis set
[29] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.392

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-2.1

upper limit

5.4

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8

Top of page

End point title

Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 8

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[30]	60 ^[31]
Units: Percentage of Participants
number (not applicable)	1.7	38.3

Notes
[30] - ITT analysis set
[31] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

36.6

Confidence interval

level

95%

sides

2-sided

lower limit

23.8

upper limit

49.3

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12

Top of page

End point title

Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 12

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[32]	60 ^[33]
Units: Percentage of Participants
number (not applicable)	5.0	61.7

Notes
[32] - ITT analysis set
[33] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

56.6

Confidence interval

level

95%

sides

2-sided

lower limit

43.2

upper limit

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16

Top of page

End point title

Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PAS190 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[34]	60 ^[35]
Units: Percentage of Participants
number (not applicable)	11.7	76.7

Notes
[34] - ITT analysis set
[35] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

64.9

Confidence interval

level

95%

sides

2-sided

lower limit

51.5

upper limit

78.3

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20

Top of page

End point title

Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 20

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[36]	60 ^[37]
Units: Percentage of Participants
number (not applicable)	16.7	83.3

Notes
[36] - ITT analysis set
[37] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

66.6

Confidence interval

level

95%

sides

2-sided

lower limit

53.3

upper limit

79.8

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4

Top of page

End point title

Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) I PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 4

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[38]	60 ^[39]
Units: Percentage of Participants
number (not applicable)	0	0

Notes
[38] - ITT analysis set
[39] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.991

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

2.1

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8

Top of page

End point title

Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data

End point type

Secondary

End point timeframe

Week 8

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[40]	60 ^[41]
Units: Percentage of Participants
number (not applicable)	1.7	5.0

Notes
[40] - ITT analysis set
[41] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.323

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

3.3

Confidence interval

level

95%

sides

2-sided

lower limit

-3.2

upper limit

9.8

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12

Top of page

End point title

Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 12

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[42]	60 ^[43]
Units: Percentage of Participants
number (not applicable)	1.7	23.3

Notes
[42] - ITT analysis set
[43] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

21.5

Confidence interval

level

95%

sides

2-sided

lower limit

10.4

upper limit

32.6

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16

Top of page

End point title

Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[44]	60 ^[45]
Units: Percentage of Participants
number (not applicable)	1.7	35.0

Notes
[44] - ITT analysis set
[45] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

33.1

Confidence interval

level

95%

sides

2-sided

lower limit

20.7

upper limit

45.5

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20

Top of page

End point title

Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 20

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[46]	60 ^[47]
Units: Percentage of Participants
number (not applicable)	6.7	48.3

Notes
[46] - ITT analysis set
[47] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

41.3

Confidence interval

level

95%

sides

2-sided

lower limit

27.3

upper limit

55.3

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24

Top of page

End point title

Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[48]	60 ^[49]
Units: Percentage of Participants
number (not applicable)	5.0	50.0

Notes
[48] - ITT analysis set
[49] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no])

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

44.7

Confidence interval

level

95%

sides

2-sided

lower limit

30.9

upper limit

58.5

Secondary: The Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4

Top of page

End point title

The Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4

End point description

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Last observation carried forward (LOCF) imputation was used for missing data.

End point type

Secondary

End point timeframe

Baseline, Week 4

End point values	Fumaderm	Risankizumab
Number of subjects analysed	58 ^[50]	60 ^[51]
Units: units on a scale
least squares mean (standard error)	-2.37 ( 0.669 )	-9.56 ( 0.673 )

Notes
[50] - ITT analysis set
[51] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-7.19

Confidence interval

level

95%

sides

2-sided

lower limit

-8.82

upper limit

-5.56

Variability estimate

Standard error of the mean

Dispersion value

0.825

Secondary: PASI: Change From Baseline to Week 8

Top of page

End point title

PASI: Change From Baseline to Week 8

End point description

End point type

Secondary

End point timeframe

Baseline, Week 8

End point values	Fumaderm	Risankizumab
Number of subjects analysed	58 ^[52]	60 ^[53]
Units: units on a scale
least squares mean (standard error)	-5.61 ( 0.759 )	-15.18 ( 0.763 )

Notes
[52] - ITT analysis set
[53] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-9.58

Confidence interval

level

95%

sides

2-sided

lower limit

-11.43

upper limit

-7.72

Variability estimate

Standard error of the mean

Dispersion value

0.936

Secondary: PASI: Change From Baseline to Week 12

Top of page

End point title

PASI: Change From Baseline to Week 12

End point description

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Fumaderm	Risankizumab
Number of subjects analysed	58 ^[54]	60 ^[55]
Units: units on a scale
least squares mean (standard error)	-7.69 ( 0.788 )	-16.49 ( 0.793 )

Notes
[54] - ITT analysis set
[55] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-8.8

Confidence interval

level

95%

sides

2-sided

lower limit

-10.72

upper limit

-6.87

Variability estimate

Standard error of the mean

Dispersion value

0.972

Secondary: PASI: Change From Baseline to Week 16

Top of page

End point title

PASI: Change From Baseline to Week 16

End point description

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	58 ^[56]	60 ^[57]
Units: units on a scale
least squares mean (standard error)	-9.11 ( 0.777 )	-16.89 ( 0.782 )

Notes
[56] - ITT analysis set
[57] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-7.78

Confidence interval

level

95%

sides

2-sided

lower limit

-9.68

upper limit

-5.88

Variability estimate

Standard error of the mean

Dispersion value

0.958

Secondary: PASI: Change From Baseline to Week 20

Top of page

End point title

PASI: Change From Baseline to Week 20

End point description

End point type

Secondary

End point timeframe

Baseline, Week 20

End point values	Fumaderm	Risankizumab
Number of subjects analysed	58 ^[58]	60 ^[59]
Units: units on a scale
least squares mean (standard error)	-9.46 ( 0.894 )	-17.35 ( 0.899 )

Notes
[58] - ITT analysis set
[59] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-7.89

Confidence interval

level

95%

sides

2-sided

lower limit

-10.07

upper limit

-5.71

Variability estimate

Standard error of the mean

Dispersion value

1.101

Secondary: PASI: Change From Baseline to Week 24

Top of page

End point title

PASI: Change From Baseline to Week 24

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	58 ^[60]	60 ^[61]
Units: units on a scale
least squares mean (standard error)	-9.31 ( 0.953 )	-17.69 ( 0.959 )

Notes
[60] - ITT analysis set
[61] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-8.39

Confidence interval

level

95%

sides

2-sided

lower limit

-10.71

upper limit

-6.06

Variability estimate

Standard error of the mean

Dispersion value

1.175

Secondary: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4

Top of page

End point title

Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4

End point description

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 4

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[62]	60 ^[63]
Units: Percentage of Participants
number (not applicable)	3.3	33.3

Notes
[62] - ITT analysis set
[63] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

29.7

Confidence interval

level

95%

sides

2-sided

lower limit

17.1

upper limit

42.4

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8

Top of page

End point title

Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8

End point description

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 8

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[64]	60 ^[65]
Units: Percentage of Participants
number (not applicable)	15.0	81.7

Notes
[64] - ITT analysis set
[65] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

66.7

Confidence interval

level

95%

sides

2-sided

lower limit

53.4

upper limit

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12

Top of page

End point title

Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12

End point description

End point type

Secondary

End point timeframe

Week 12

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[66]	60 ^[67]
Units: Percentage of Participants
number (not applicable)	33.3	90.0

Notes
[66] - ITT analysis set
[67] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

56.8

Confidence interval

level

95%

sides

2-sided

lower limit

42.7

upper limit

70.8

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16

Top of page

End point title

Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16

End point description

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[68]	60 ^[69]
Units: Percentage of Participants
number (not applicable)	31.7	91.7

Notes
[68] - ITT analysis set
[69] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

59.9

Confidence interval

level

95%

sides

2-sided

lower limit

46.3

upper limit

73.6

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20

Top of page

End point title

Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20

End point description

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 20

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[70]	60 ^[71]
Units: Percentage of Participants
number (not applicable)	48.3	93.3

Notes
[70] - ITT analysis set
[71] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

44.9

Confidence interval

level

95%

sides

2-sided

lower limit

30.8

upper limit

59.1

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 24

Top of page

End point title

Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 24

End point description

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	58 ^[72]	60 ^[73]
Units: Percentage of Participants
number (not applicable)	38.3	93.3

Notes
[72] - ITT Analysis Set
[73] - ITT Analysis Set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

41.2

upper limit

68.8

Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 4

Top of page

End point title

Percentage of Participants Achieving sPGA Score of Clear at Week 4

End point description

End point type

Secondary

End point timeframe

Week 4

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[74]	60 ^[75]
Units: Percentage of Participants
number (not applicable)	0	1.7

Notes
[74] - ITT analysis set
[75] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Risankizumab v Fumaderm

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.392

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-2.1

upper limit

5.4

Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 8

Top of page

End point title

Percentage of Participants Achieving sPGA Score of Clear at Week 8

End point description

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 8

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[76]	60 ^[77]
Units: Percentage of Participants
number (not applicable)	1.7	10.0

Notes
[76] - ITT analysis set
[77] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.048

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

8.4

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

16.7

Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 12

Top of page

End point title

Percentage of Participants Achieving sPGA Score of Clear at Week 12

End point description

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 12

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[78]	60 ^[79]
Units: Percentage of Participants
number (not applicable)	3.3	21.7

Notes
[78] - ITT analysis set
[79] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

18.3

Confidence interval

level

95%

sides

2-sided

lower limit

7.1

upper limit

29.5

Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 16

Top of page

End point title

Percentage of Participants Achieving sPGA Score of Clear at Week 16

End point description

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[80]	60 ^[81]
Units: Percentage of Participants
number (not applicable)	3.3	36.7

Notes
[80] - ITT analysis set
[81] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

20.2

upper limit

45.9

Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 20

Top of page

End point title

Percentage of Participants Achieving sPGA Score of Clear at Week 20

End point description

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 20

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[82]	60 ^[83]
Units: Percentage of Participants
number (not applicable)	6.7	48.3

Notes
[82] - ITT analysis set
[83] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

41.3

Confidence interval

level

95%

sides

2-sided

lower limit

27.3

upper limit

55.3

Secondary: Percentage of Participants Achieving sPGA Score of Clear at Week 24

Top of page

End point title

Percentage of Participants Achieving sPGA Score of Clear at Week 24

End point description

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[84]	60 ^[85]
Units: Percentage of Participants
number (not applicable)	5.0	51.7

Notes
[84] - ITT analysis set
[85] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

46.4

Confidence interval

level

95%

sides

2-sided

lower limit

32.6

upper limit

60.1

Secondary: Percentage of Participants With Psoriasis Symptoms Scale (PSS) Score of 0 at Week 16

Top of page

End point title

Percentage of Participants With Psoriasis Symptoms Scale (PSS) Score of 0 at Week 16

End point description

The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[86]	60 ^[87]
Units: Percentage of Participants
number (not applicable)	5.0	25.0

Notes
[86] - ITT analysis set
[87] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

19.8

Confidence interval

level

95%

sides

2-sided

lower limit

7.6

upper limit

31.9

Secondary: Percentage of Participants With PSS Score of 0 at Week 24

Top of page

End point title

Percentage of Participants With PSS Score of 0 at Week 24

End point description

End point type

Secondary

End point timeframe

Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[88]	60 ^[89]
Units: Percentage of Participants
number (not applicable)	3.3	41.7

Notes
[88] - ITT analysis set
[89] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

38.3

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

51.5

Secondary: PSS Total Score: Change From Baseline to Week 16

Top of page

End point title

PSS Total Score: Change From Baseline to Week 16

End point description

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	55 ^[90]	59 ^[91]
Units: units on a scale
least squares mean (standard error)	-5.5 ( 0.52 )	-8.7 ( 0.51 )

Notes
[90] - ITT analysis set
[91] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated by stratified van Elteren test.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

114

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

van Elteren test

Parameter type

Least Squares Mean Difference

Point estimate

-3.2

Confidence interval

level

95%

sides

2-sided

lower limit

-4.5

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

0.63

Secondary: PSS Total Score: Change From Baseline to Week 24

Top of page

End point title

PSS Total Score: Change From Baseline to Week 24

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	55 ^[92]	60 ^[93]
Units: units on a scale
least squares mean (standard error)	-5.6 ( 0.49 )	-9.5 ( 0.48 )

Notes
[92] - ITT analysis set
[93] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated by stratified van Elteren test.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

van Elteren test

Parameter type

Least Squares Mean Difference

Point estimate

-3.9

Confidence interval

level

95%

sides

2-sided

lower limit

-5.1

upper limit

-2.7

Variability estimate

Standard error of the mean

Dispersion value

0.59

Secondary: Summary of Patient Benefit Index (PBI) at Week 16

Top of page

End point title

Summary of Patient Benefit Index (PBI) at Week 16

End point description

The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (Patient Needs Questionnaire [PNQ]). After treatment, the participant rates the degree of benefits achieved (Patient Benefits Questionnaire [PBQ]). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for "did not apply to me" (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data.

End point type

Secondary

End point timeframe

Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	54 ^[94]	59 ^[95]
Units: units on a scale
arithmetic mean (standard deviation)	1.970 ( 1.1971 )	3.118 ( 0.8246 )

Notes
[94] - ITT analysis set
[95] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

113

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

1.146

Confidence interval

level

95%

sides

2-sided

lower limit

0.764

upper limit

1.528

Secondary: Summary of PBI at Week 24

Top of page

End point title

Summary of PBI at Week 24

End point description

The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment. The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment. The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (PNQ). After treatment, the participant rates the degree of benefits achieved (PBQ). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for "did not apply to me" (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data.

End point type

Secondary

End point timeframe

Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	54 ^[96]	60 ^[97]
Units: units on a scale
arithmetic mean (standard deviation)	1.997 ( 1.2710 )	3.316 ( 0.7487 )

Notes
[96] - ITT analysis set
[97] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

114

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

1.32

Confidence interval

level

95%

sides

2-sided

lower limit

0.936

upper limit

1.704

Secondary: Clinical Severity of Nail Psoriasis (NAPPA-CLIN) Total Score: Change From Baseline to Week 16

Top of page

End point title

Clinical Severity of Nail Psoriasis (NAPPA-CLIN) Total Score: Change From Baseline to Week 16

End point description

The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the Nail Psoriasis Severity Index (NAPSI) score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	56 ^[98]	58 ^[99]
Units: units on a scale
arithmetic mean (standard error)	-0.4 ( 0.51 )	-2.7 ( 0.51 )

Notes
[98] - ITT analysis set
[99] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

114

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-2.3

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

-1.1

Variability estimate

Standard error of the mean

Dispersion value

0.63

Secondary: NAPPA-CLIN Total Score: Change From Baseline to Week 24

Top of page

End point title

NAPPA-CLIN Total Score: Change From Baseline to Week 24

End point description

The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the NAPSI score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	56 ^[100]	58 ^[101]
Units: units on a scale
arithmetic mean (standard error)	-0.7 ( 0.53 )	-3.7 ( 0.54 )

Notes
[100] - ITT analysis set
[101] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

114

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-4.3

upper limit

-1.6

Variability estimate

Standard error of the mean

Dispersion value

0.66

Secondary: Palmoplantar Psoriasis Severity Index (PPASI): Change From Baseline to Week 16

Top of page

End point title

Palmoplantar Psoriasis Severity Index (PPASI): Change From Baseline to Week 16

End point description

The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	56 ^[102]	60 ^[103]
Units: units on a scale
arithmetic mean (standard error)	-0.76 ( 0.251 )	-1.04 ( 0.249 )

Notes
[102] - ITT analysis set
[103] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

116

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.352

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-0.29

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

0.32

Variability estimate

Standard error of the mean

Dispersion value

0.307

Secondary: PPASI: Change From Baseline to Week 24

Top of page

End point title

PPASI: Change From Baseline to Week 24

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	56 ^[104]	60 ^[105]
Units: units on a scale
arithmetic mean (standard error)	-0.87 ( 0.242 )	-1.17 ( 0.240 )

Notes
[104] - ITT analysis set
[105] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

116

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.315

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-0.88

upper limit

0.29

Variability estimate

Standard error of the mean

Dispersion value

0.296

Secondary: Body Surface Area (BSA) Affected by Psoriasis: Change From Baseline to Week 4

Top of page

End point title

Body Surface Area (BSA) Affected by Psoriasis: Change From Baseline to Week 4

End point description

BSA affected by psoriasis was measured by the physician selecting the participants right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.

End point type

Secondary

End point timeframe

Baseline, Week 4

End point values	Fumaderm	Risankizumab
Number of subjects analysed	58 ^[106]	60 ^[107]
Units: percentage estimated body surface area
least squares mean (standard error)	-0.3 ( 0.86 )	-5.2 ( 0.86 )

Notes
[106] - ITT Analysis Set
[107] - ITT Analysis Set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-4.8

Confidence interval

level

95%

sides

2-sided

lower limit

-6.9

upper limit

-2.7

Variability estimate

Standard error of the mean

Dispersion value

1.06

Secondary: BSA Affected by Psoriasis: Change From Baseline to Week 8

Top of page

End point title

BSA Affected by Psoriasis: Change From Baseline to Week 8

End point description

BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.

End point type

Secondary

End point timeframe

Baseline, Week 8

End point values	Fumaderm	Risankizumab
Number of subjects analysed	58 ^[108]	60 ^[109]
Units: percentage estimated body surface area
least squares mean (standard error)	-3.5 ( 1.33 )	-12.8 ( 1.33 )

Notes
[108] - ITT Analysis Set
[109] - ITT Analysis Set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-9.3

Confidence interval

level

95%

sides

2-sided

lower limit

-12.6

upper limit

-6.1

Variability estimate

Standard error of the mean

Dispersion value

1.64

Secondary: BSA Affected by Psoriasis: Change From Baseline to Week 12

Top of page

End point title

BSA Affected by Psoriasis: Change From Baseline to Week 12

End point description

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Fumaderm	Risankizumab
Number of subjects analysed	58 ^[110]	60 ^[111]
Units: percentage estimated body surface area
least squares mean (standard error)	-6.0 ( 1.22 )	-16.2 ( 1.23 )

Notes
[110] - ITT Analysis Set
[111] - ITT Analysis Set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-10.2

Confidence interval

level

95%

sides

2-sided

lower limit

-13.2

upper limit

-7.2

Variability estimate

Standard error of the mean

Dispersion value

1.51

Secondary: BSA Affected by Psoriasis: Change From Baseline to Week 16

Top of page

End point title

BSA Affected by Psoriasis: Change From Baseline to Week 16

End point description

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	58 ^[112]	60 ^[113]
Units: percentage estimated body surface area
least squares mean (standard error)	-8.2 ( 1.22 )	-18.0 ( 1.22 )

Notes
[112] - ITT Analysis Set
[113] - ITT Analysis Set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-9.8

Confidence interval

level

95%

sides

2-sided

lower limit

-12.8

upper limit

-6.8

Variability estimate

Standard error of the mean

Dispersion value

1.51

Secondary: BSA Affected by Psoriasis: Change From Baseline to Week 20

Top of page

End point title

BSA Affected by Psoriasis: Change From Baseline to Week 20

End point description

End point type

Secondary

End point timeframe

Baseline, Week 20

End point values	Fumaderm	Risankizumab
Number of subjects analysed	58 ^[114]	60 ^[115]
Units: percentage estimated body surface area
least squares mean (standard error)	-9.7 ( 1.13 )	-19.3 ( 1.13 )

Notes
[114] - ITT Analysis Set
[115] - ITT Analysis Set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-9.6

Confidence interval

level

95%

sides

2-sided

lower limit

-12.4

upper limit

-6.8

Variability estimate

Standard error of the mean

Dispersion value

1.39

Secondary: BSA Affected by Psoriasis: Change From Baseline to Week 24

Top of page

End point title

BSA Affected by Psoriasis: Change From Baseline to Week 24

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	58 ^[116]	60 ^[117]
Units: percentage estimated body surface area
least squares mean (standard error)	-9.8 ( 1.19 )	-19.8 ( 1.19 )

Notes
[116] - ITT Analysis Set
[117] - ITT Analysis Set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

118

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-10

Confidence interval

level

95%

sides

2-sided

lower limit

-12.9

upper limit

-7.1

Variability estimate

Standard error of the mean

Dispersion value

1.47

Secondary: Short Form Health Survey 36, Version 2 (SF-36 V2) Physical Component Summary (PCS) Score: Change From Baseline to Week 16

Top of page

End point title

Short Form Health Survey 36, Version 2 (SF-36 V2) Physical Component Summary (PCS) Score: Change From Baseline to Week 16

End point description

The SF-36 V2 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	55 ^[118]	59 ^[119]
Units: units on a scale
least squares mean (standard error)	2.87 ( 1.153 )	7.36 ( 1.135 )

Notes
[118] - ITT analysis set
[119] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

114

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.002

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

4.49

Confidence interval

level

95%

sides

2-sided

lower limit

1.74

upper limit

7.23

Variability estimate

Standard error of the mean

Dispersion value

1.385

Secondary: SF-36 V2 PCS Score: Change From Baseline to Week 24

Top of page

End point title

SF-36 V2 PCS Score: Change From Baseline to Week 24

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	55 ^[120]	60 ^[121]
Units: units on a scale
least squares mean (standard error)	3.68 ( 1.104 )	8.31 ( 1.083 )

Notes
[120] - ITT analysis set
[121] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

4.63

Confidence interval

level

95%

sides

2-sided

lower limit

2.01

upper limit

7.25

Variability estimate

Standard error of the mean

Dispersion value

1.322

Secondary: SF-36 V2 Mental Component Summary (MCS) Score: Change From Baseline: to Week 16

Top of page

End point title

SF-36 V2 Mental Component Summary (MCS) Score: Change From Baseline: to Week 16

End point description

The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	55 ^[122]	59 ^[123]
Units: units on a scale
least squares mean (standard error)	4.20 ( 1.493 )	10.86 ( 1.472 )

Notes
[122] - ITT analysis set
[123] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

114

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

6.66

Confidence interval

level

95%

sides

2-sided

lower limit

3.11

upper limit

10.2

Variability estimate

Standard error of the mean

Dispersion value

1.787

Secondary: SF-36 V2 MCS Score: Change From Baseline to Week 24

Top of page

End point title

SF-36 V2 MCS Score: Change From Baseline to Week 24

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	55 ^[124]	60 ^[125]
Units: units on a scale
least squares mean (standard error)	3.56 ( 1.494 )	11.41 ( 1.470 )

Notes
[124] - ITT analysis set
[125] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

7.85

Confidence interval

level

95%

sides

2-sided

lower limit

4.31

upper limit

11.38

Variability estimate

Standard error of the mean

Dispersion value

1.784

Secondary: Patient's Global Assessment (PtGA): Change From Baseline to Week 16

Top of page

End point title

Patient's Global Assessment (PtGA): Change From Baseline to Week 16

End point description

The PtGA is a patient-reported outcome instrument to assess the patient's assessment of disease severity. This self-reported measure is used to assess disease activity using a 4-point scale where a higher score indicates a higher level of disease activity. Disease activity is assessed from 0 ("complete disease control") to 3 ("uncontrolled disease"). LOCF imputation was used for missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	56 ^[126]	59 ^[127]
Units: units on a scale
least squares mean (standard error)	-1.0 ( 0.11 )	-1.9 ( 0.11 )

Notes
[126] - ITT analysis set
[127] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-1

Confidence interval

level

95%

sides

2-sided

lower limit

-1.2

upper limit

-0.7

Variability estimate

Standard error of the mean

Dispersion value

0.13

Secondary: PtGA: Change From Baseline to Week 24

Top of page

End point title

PtGA: Change From Baseline to Week 24

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	56 ^[128]	60 ^[129]
Units: units on a scale
least squares mean (standard error)	-1.0 ( 0.11 )	-2.0 ( 0.11 )

Notes
[128] - ITT analysis set
[129] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

116

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-1

Confidence interval

level

95%

sides

2-sided

lower limit

-1.3

upper limit

-0.8

Variability estimate

Standard error of the mean

Dispersion value

0.13

Secondary: Hospital Anxiety and Depression Scale (HADS) Total Score-Anxiety: Change From Baseline to Week 16

Top of page

End point title

Hospital Anxiety and Depression Scale (HADS) Total Score-Anxiety: Change From Baseline to Week 16

End point description

The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the selling of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	55 ^[130]	59 ^[131]
Units: units on a scale
least squares mean (standard error)	-2.2 ( 0.48 )	-4.3 ( 0.47 )

Notes
[130] - ITT analysis set
[131] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

114

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Confidence interval

level

95%

sides

2-sided

lower limit

-3.2

upper limit

-0.9

Variability estimate

Standard error of the mean

Dispersion value

0.57

Secondary: HADS Total Score-Anxiety: Change From Baseline to Week 24

Top of page

End point title

HADS Total Score-Anxiety: Change From Baseline to Week 24

End point description

The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	55 ^[132]	60 ^[133]
Units: units on a scale
least squares mean (standard error)	-1.8 ( 0.49 )	-4.0 ( 0.48 )

Notes
[132] - ITT analysis set
[133] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-2.3

Confidence interval

level

95%

sides

2-sided

lower limit

-3.5

upper limit

-1.1

Variability estimate

Standard error of the mean

Dispersion value

0.59

Secondary: HADS Total Score-Depression: Change From Baseline to Week 16

Top of page

End point title

HADS Total Score-Depression: Change From Baseline to Week 16

End point description

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	55 ^[134]	59 ^[135]
Units: units on a scale
least squares mean (standard error)	-1.8 ( 0.50 )	-4.9 ( 0.50 )

Notes
[134] - ITT analysis set
[135] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

114

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-3.1

Confidence interval

level

95%

sides

2-sided

lower limit

-4.3

upper limit

-1.9

Variability estimate

Standard error of the mean

Dispersion value

0.61

Secondary: HADS Total Score-Depression: Change From Baseline to Week 24

Top of page

End point title

HADS Total Score-Depression: Change From Baseline to Week 24

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	55 ^[136]	60 ^[137]
Units: units on a scale
least squares mean (standard error)	-1.7 ( 0.54 )	-4.8 ( 0.53 )

Notes
[136] - ITT analysis set
[137] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-3.1

Confidence interval

level

95%

sides

2-sided

lower limit

-4.4

upper limit

-1.8

Variability estimate

Standard error of the mean

Dispersion value

0.65

Secondary: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16

Top of page

End point title

Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16

End point description

The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.

End point type

Secondary

End point timeframe

Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[138]	60 ^[139]
Units: Percentage of Participants
number (not applicable)	10.0	48.3

Notes
[138] - ITT analysis set
[139] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

38.3

Confidence interval

level

95%

sides

2-sided

lower limit

23.6

upper limit

53.1

Secondary: Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 24

Top of page

End point title

Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 24

End point description

End point type

Secondary

End point timeframe

Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	60 ^[140]	60 ^[141]
Units: Percentage of Participants
number (not applicable)	10.0	66.7

Notes
[140] - ITT analysis set
[141] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

120

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted percentage difference

Point estimate

56.8

Confidence interval

level

95%

sides

2-sided

lower limit

42.7

upper limit

70.9

Secondary: DLQI Total Score: Change From Baseline to Week 16

Top of page

End point title

DLQI Total Score: Change From Baseline to Week 16

End point description

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	56 ^[142]	59 ^[143]
Units: units on a scale
least squares mean (standard error)	-9.7 ( 0.94 )	-17.0 ( 0.94 )

Notes
[142] - ITT analysis set
[143] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with prior phototherapy (yes/no), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-7.4

Confidence interval

level

95%

sides

2-sided

lower limit

-9.6

upper limit

-5.1

Variability estimate

Standard error of the mean

Dispersion value

1.15

Secondary: DLQI: Change From Baseline to Week 24

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End point title

DLQI: Change From Baseline to Week 24

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	56 ^[144]	60 ^[145]
Units: units on a scale
least squares mean (standard error)	-11.2 ( 0.87 )	-18.8 ( 0.87 )

Notes
[144] - ITT analysis set
[145] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

116

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-7.6

Confidence interval

level

95%

sides

2-sided

lower limit

-9.7

upper limit

-5.5

Variability estimate

Standard error of the mean

Dispersion value

1.06

Secondary: Psoriasis Scalp Severity Index (PSSI): Change From Baseline at Week 16

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End point title

Psoriasis Scalp Severity Index (PSSI): Change From Baseline at Week 16

End point description

The physician assessed the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved). The composite score is calculated as the sum of symptom scores multiplied by the score for the area of scalp involved. The PSSI ranges from 0 (best) to 72 (worst). A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	56 ^[146]	60 ^[147]
Units: units on a scale
least squares mean (standard error)	-14.6 ( 1.01 )	-21.2 ( 1.01 )

Notes
[146] - ITT analysis set
[147] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

116

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-6.6

Confidence interval

level

95%

sides

2-sided

lower limit

-9

upper limit

-4.1

Variability estimate

Standard error of the mean

Dispersion value

1.23

Secondary: PSSI: Change From Baseline at Week 24

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End point title

PSSI: Change From Baseline at Week 24

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	56 ^[148]	60 ^[149]
Units: units on a scale
least squares mean (standard error)	-13.9 ( 1.25 )	-22.0 ( 1.25 )

Notes
[148] - ITT analysis set
[149] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

116

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-8.1

Confidence interval

level

95%

sides

2-sided

lower limit

-11.1

upper limit

-5

Variability estimate

Standard error of the mean

Dispersion value

1.53

Secondary: European Quality of Life 5 Dimensions (EQ-5D-5L) Total Score: Change From Baseline to Week 16

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End point title

European Quality of Life 5 Dimensions (EQ-5D-5L) Total Score: Change From Baseline to Week 16

End point description

The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-50-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	55 ^[150]	58 ^[151]
Units: units on a scale
least squares mean (standard error)	0.083 ( 0.0179 )	0.171 ( 0.0176 )

Notes
[150] - ITT analysis set
[151] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

113

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

0.087

Confidence interval

level

95%

sides

2-sided

lower limit

0.045

upper limit

0.13

Variability estimate

Standard error of the mean

Dispersion value

0.0215

Secondary: EQ-5D-5L Total Score: Change From Baseline to Week 24

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End point title

EQ-5D-5L Total Score: Change From Baseline to Week 24

End point description

The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data.

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	55 ^[152]	60 ^[153]
Units: units on a scale
least squares mean (standard error)	0.106 ( 0.0155 )	0.165 ( 0.0152 )

Notes
[152] - ITT analysis set
[153] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.002

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

0.059

Confidence interval

level

95%

sides

2-sided

lower limit

0.022

upper limit

0.096

Variability estimate

Standard error of the mean

Dispersion value

0.0186

Secondary: EQ-5D-5L Visual Analog Scale (VAS): Change From Baseline to Week 16

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End point title

EQ-5D-5L Visual Analog Scale (VAS): Change From Baseline to Week 16

End point description

The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). The VAS score from the scale is then entered as a number by the participant. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. An increase in the EQ-5D-5L VAS score indicates improvement. LOCF imputation was used for missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	55 ^[154]	58 ^[155]
Units: units on a scale
least squares mean (standard error)	11.0 ( 2.32 )	26.0 ( 2.28 )

Notes
[154] - ITT analysis set
[155] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

113

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

14.9

Confidence interval

level

95%

sides

2-sided

lower limit

9.4

upper limit

20.5

Variability estimate

Standard error of the mean

Dispersion value

2.8

Secondary: EQ-5D-5L VAS: Change From Baseline to Week 24

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End point title

EQ-5D-5L VAS: Change From Baseline to Week 24

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	55 ^[156]	60 ^[157]
Units: units on a scale
least squares mean (standard error)	11.6 ( 2.29 )	28.4 ( 2.23 )

Notes
[156] - ITT analysis set
[157] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

16.8

Confidence interval

level

95%

sides

2-sided

lower limit

11.4

upper limit

22.2

Variability estimate

Standard error of the mean

Dispersion value

2.73

Secondary: Nail Psoriasis Severity Index (NAPSI): Change From Baseline to Week 16

Top of page

End point title

Nail Psoriasis Severity Index (NAPSI): Change From Baseline to Week 16

End point description

The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	56 ^[158]	58 ^[159]
Units: units on a scale
least squares mean (standard error)	-2.2 ( 2.13 )	-13.6 ( 2.14 )

Notes
[158] - ITT analysis set
[159] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

114

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-11.4

Confidence interval

level

95%

sides

2-sided

lower limit

-16.6

upper limit

-6.2

Variability estimate

Standard error of the mean

Dispersion value

2.64

Secondary: NAPSI: Change From Baseline to Week 24

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End point title

NAPSI: Change From Baseline to Week 24

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	56 ^[160]	58 ^[161]
Units: units on a scale
least squares mean (standard error)	-4.4 ( 2.18 )	-18.1 ( 2.19 )

Notes
[160] - ITT analysis set
[161] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

114

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-13.7

Confidence interval

level

95%

sides

2-sided

lower limit

-19.1

upper limit

-8.4

Variability estimate

Standard error of the mean

Dispersion value

2.7

Secondary: Participants With Baseline NAPSI >0: Change From Baseline to Week 16

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End point title

Participants With Baseline NAPSI >0: Change From Baseline to Week 16

End point description

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Fumaderm	Risankizumab
Number of subjects analysed	33 ^[162]	42 ^[163]
Units: units on a scale
least squares mean (standard error)	-4.2 ( 3.11 )	-21.4 ( 2.86 )

Notes
[162] - ITT analysis set
[163] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-17.3

Confidence interval

level

95%

sides

2-sided

lower limit

-24.8

upper limit

-9.8

Variability estimate

Standard error of the mean

Dispersion value

3.75

Secondary: Participants With Baseline NAPSI >0: Change From Baseline to Week 24

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End point title

Participants With Baseline NAPSI >0: Change From Baseline to Week 24

End point description

End point type

Secondary

End point timeframe

Baseline, Week 24

End point values	Fumaderm	Risankizumab
Number of subjects analysed	33 ^[164]	42 ^[165]
Units: units on a scale
least squares mean (standard error)	-6.0 ( 3.03 )	-27.5 ( 2.79 )

Notes
[164] - ITT analysis set
[165] - ITT analysis set

Statistical Analysis 1

Statistical analysis description

P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.

Comparison groups

Fumaderm v Risankizumab

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

ANCOVA

Parameter type

Least Squares Mean Difference

Point estimate

-21.5

Confidence interval

level

95%

sides

2-sided

lower limit

-28.8

upper limit

-14.2

Variability estimate

Standard error of the mean

Dispersion value

3.66

Adverse events

Top of page

Timeframe for reporting adverse events

Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of risankizumab (up to 31 weeks) or until 1 week after the last dose of Fumaderm (up to 25 weeks)

Adverse event reporting additional description

Safety analysis set included all participants enrolled in the study and who received at least 1 dose of study drug (N = 117).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.0

Reporting group title

Fumaderm

Reporting group description

Participants randomized to receive open-label Fumaderm Initial once daily from Week 0 to Week 2 and Fumaderm once daily from Week 3 to Week 24.

Reporting group title

Risankizumab

Reporting group description

Participants randomized to receive open-label risankizumab 150 mg at Weeks 0, 4, and 16.

Serious adverse events	Fumaderm	Risankizumab
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 57 (3.51%)	1 / 60 (1.67%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
subjects affected / exposed	0 / 57 (0.00%)	1 / 60 (1.67%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 57 (1.75%)	0 / 60 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Influenza
subjects affected / exposed	0 / 57 (0.00%)	1 / 60 (1.67%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Obesity
subjects affected / exposed	1 / 57 (1.75%)	0 / 60 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Fumaderm	Risankizumab
Total subjects affected by non serious adverse events
subjects affected / exposed	54 / 57 (94.74%)	45 / 60 (75.00%)
Vascular disorders
Flushing
subjects affected / exposed	23 / 57 (40.35%)	0 / 60 (0.00%)
occurrences all number	28	0
Hypertension
subjects affected / exposed	2 / 57 (3.51%)	4 / 60 (6.67%)
occurrences all number	2	4
Nervous system disorders
Dizziness
subjects affected / exposed	4 / 57 (7.02%)	0 / 60 (0.00%)
occurrences all number	4	0
Headache
subjects affected / exposed	7 / 57 (12.28%)	5 / 60 (8.33%)
occurrences all number	15	6
Migraine
subjects affected / exposed	3 / 57 (5.26%)	0 / 60 (0.00%)
occurrences all number	3	0
Blood and lymphatic system disorders
Lymphopenia
subjects affected / exposed	8 / 57 (14.04%)	0 / 60 (0.00%)
occurrences all number	9	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	11 / 57 (19.30%)	0 / 60 (0.00%)
occurrences all number	13	0
Abdominal pain upper
subjects affected / exposed	26 / 57 (45.61%)	1 / 60 (1.67%)
occurrences all number	34	1
Diarrhoea
subjects affected / exposed	32 / 57 (56.14%)	4 / 60 (6.67%)
occurrences all number	57	4
Nausea
subjects affected / exposed	9 / 57 (15.79%)	0 / 60 (0.00%)
occurrences all number	12	0
Toothache
subjects affected / exposed	0 / 57 (0.00%)	3 / 60 (5.00%)
occurrences all number	0	4
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
subjects affected / exposed	2 / 57 (3.51%)	5 / 60 (8.33%)
occurrences all number	2	5
Skin and subcutaneous tissue disorders
Pruritus
subjects affected / exposed	5 / 57 (8.77%)	2 / 60 (3.33%)
occurrences all number	8	2
Skin burning sensation
subjects affected / exposed	3 / 57 (5.26%)	0 / 60 (0.00%)
occurrences all number	3	0
Urticaria
subjects affected / exposed	4 / 57 (7.02%)	0 / 60 (0.00%)
occurrences all number	4	0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	3 / 57 (5.26%)	2 / 60 (3.33%)
occurrences all number	3	2
Pain in extremity
subjects affected / exposed	3 / 57 (5.26%)	2 / 60 (3.33%)
occurrences all number	3	2
Infections and infestations
Bronchitis
subjects affected / exposed	3 / 57 (5.26%)	3 / 60 (5.00%)
occurrences all number	3	3
Influenza
subjects affected / exposed	3 / 57 (5.26%)	4 / 60 (6.67%)
occurrences all number	3	4
Nasopharyngitis
subjects affected / exposed	26 / 57 (45.61%)	35 / 60 (58.33%)
occurrences all number	32	47
Rhinitis
subjects affected / exposed	3 / 57 (5.26%)	3 / 60 (5.00%)
occurrences all number	4	4

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

13 Mar 2017

Revisions included changing the pharmacokinetic and anti-drug antibody sample collection from plasma to serum as the bioanalysis method utilizes serum instead of plasma. The study schematic was updated to reflect timing of dosing of FUMADERM® INITIAL and FUMADERM®.

05 Jul 2017

Revisions included updating the number of study sites from approximately 20 to approximately 25 sites, clarifying that the duration of treatment is 16 weeks for risankizumab vs 24 weeks for FUMADERM®. Changes made to Exclusion Criteria included changing language of complete blood count and microalbuminuria and specifying that the relevant values are from Screening. Exclusion Criterion 14 was modified to make the language closer to medical practice and closely control blood pressure to prevent the risk of renal insufficiency associated with FUMADERM®. Prior phototherapy was modified, as UV-therapy and balneotherapy are considered systemic therapy when associated with UV-sensitizing agents and are not considered systemic therapy when they are not associated with UV-sensitizing agents. A cap for stratum of participants with prior phototherapy resulted in changes regarding stratification of randomization and corresponding analyses. Blood pressure measurement technique was provided to improve screening of the participants who will request a consultation to explore elevated blood pressure values at the Screening visit. Study Procedures clarification was made that differential white blood cell count should be transferred as absolute (not relative) values for consistency within the protocol. A slow increase in FUMADERM® INITIAL or FUMADERM® dose or a return to FUMADERM® INITIAL after initiation of FUMADERM® clarification was added in order to increase the retention of participants randomized to FUMADERM®. For NAPPA-CLIN: specifying that use of artificial nails and/or nail polish should be avoided for participants with nail psoriasis to optimize nail assessment and to record the severity of nail psoriasis for all fingers and toes in the e-CRF instead of only the worst affected one and the least affected one. The Rheumatology Common Toxicity Criteria v.2.0 was removed as this is no longer used in the risankizumab program.

28 Nov 2017

Revisions included a change to Prohibited Therapy: moving the time point from which phototherapy (e.g., UVA, UVB, any other UV-therapy or balneotherapy) not-associated with systemic UV-sensitizing agents, topical treatment for psoriasis or any other skin condition (e.g., corticosteroids,c vitamin D analogues, vitamin A analogues, pimecrolimus, retinoids, salicylvaseline, salicylic acid, lactic acid, tacrolimus, tar, urea, andanthralin, α-hydroxy acid, fruit acids) are prohibited from 14 days prior to Screening to 14 days prior to Baseline. The half-life of those therapies is short and no interaction with study medication is to be expected if they are discontinued 14 weeks before 1st dose of study medication, i.e., 14 days before Baseline (Day 1, Week 0). FUMADERM® INITIAL and FUMADERM® Subject Diary: Clarified that the subject diary dispensed at every visit, starting at the Week 0/Baseline Visit rather than at the Screening Visit, and training will occur at the Week 0/Baseline Visit. Discontinuation of Subjects on FUMADERM®: Restriction of the discontinuation of the participants on FUMADERM® for rash/flush to those with severe rash/flush to be consistent with clinical practice where only severe persistent rash/flush leads to discontinuation of patients from FUMADERM®. FUMADERM® label does not request discontinuation of FUMADERM® treatment for all adverse events of rash/flush, but says: "... severe forms (of rash/flush) may lead to (FUMADERM®) treatment discontinuation." Treatments Administered: "Additional dosing instructions will be provided separately from this protocol" was removed as risankizumab administered by site personnel only, so no additional instructions on administering SC injection required. Prohibition of artificial nail and/or nail polish to all participants instead of participants with nail psoriasis only changed as analysis of efficacy on nail psoriasis planned on all participants regardless of concomitant nail psoriasis.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Randomized, Controlled, Multicenter, Open Label Study with Blinded Assessment of the Efficacy of the Humanized Anti-IL-23p19 Risankizumab Compared to FUMADERM® in Subjects with Moderate to Severe Plaque Psoriasis Who are Naïve to and Candidates for Systemic Therapy

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24

Primary: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24

Secondary: Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24

Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4

Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4

Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8

Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8

Secondary: Percentage of Participants Achieving 75% Improvement in PAST Score (PAS175) at Week 12

Secondary: Percentage of Participants Achieving 75% Improvement in PAST Score (PAS175) at Week 12

Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16

Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16

Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20

Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20

Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24

Secondary: Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20

Secondary: Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24

Secondary: Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24

Secondary: The Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4

Secondary: The Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4

Secondary: PASI: Change From Baseline to Week 8

Secondary: PASI: Change From Baseline to Week 8

Secondary: PASI: Change From Baseline to Week 12

Secondary: PASI: Change From Baseline to Week 12

Secondary: PASI: Change From Baseline to Week 16

Secondary: PASI: Change From Baseline to Week 16

Secondary: PASI: Change From Baseline to Week 20

Secondary: PASI: Change From Baseline to Week 20

Secondary: PASI: Change From Baseline to Week 24

Secondary: PASI: Change From Baseline to Week 24

Secondary: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4

Secondary: Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20

Secondary: Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20

Clinical Trial Results:
A Randomized, Controlled, Multicenter, Open Label Study with Blinded Assessment of the Efficacy of the Humanized Anti-IL-23p19 Risankizumab Compared to FUMADERM® in Subjects with Moderate to Severe Plaque Psoriasis Who are Naïve to and Candidates for Systemic Therapy