Clinical Trial Results:
A Randomized, Controlled, Multicenter, Open Label Study with Blinded Assessment of the Efficacy of the Humanized AntiIL23p19 Risankizumab Compared to FUMADERM® in Subjects with Moderate to Severe Plaque Psoriasis Who are Naïve to and Candidates for Systemic Therapy
Summary


EudraCT number 
201600371828 
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 

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


Trial identification


Sponsor protocol code 
M16178


Additional study identifiers


ISRCTN number 
  
US NCT number 
NCT03255382  
WHO universal trial number (UTN) 
  
Sponsors


Sponsor organisation name 
AbbVie Deutschland GmbH & Co. KG


Sponsor organisation address 
AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL64UB


Public contact 
Global Medical Services, AbbVie , 001 8006339110,


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


Paediatric regulatory details


Is trial part of an agreed paediatric investigation plan (PIP) 
No


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


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


Results analysis stage


Analysis stage 
Final


Date of interim/final analysis 
06 Jul 2018


Is this the analysis of the primary completion data? 
No


Global end of trial reached? 
Yes


Global end of trial date 
06 Jul 2018


Was the trial ended prematurely? 
No


General information about the trial


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 followup planned 
No


Independent data monitoring committee (IDMC) involvement? 
No


Population of trial subjects


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 
0


Preterm newborn  gestational age < 37 wk 
0


Newborns (027 days) 
0


Infants and toddlers (28 days23 months) 
0


Children (211 years) 
0


Adolescents (1217 years) 
0


Adults (1864 years) 
113


From 65 to 84 years 
7


85 years and over 
0



Recruitment


Recruitment details 
Intenttotreat (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).  
Preassignment


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


Period 1 title 
Overall Trial (overall period)


Is this the baseline period? 
Yes  
Allocation method 
Randomised  controlled


Blinding used 
Not blinded  
Arms


Are arms mutually exclusive 
Yes


Arm title

Fumaderm  
Arm description 
Participants randomized to receive openlabel 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


Arm title

Risankizumab  
Arm description 
Participants randomized to receive openlabel 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 
ABBV066, BI 655066


Pharmaceutical forms 
Injection


Routes of administration 
Subcutaneous use


Dosage and administration details 
Risankizumab administered by subcutaneous (SC) injection





Baseline characteristics reporting groups


Reporting group title 
Fumaderm


Reporting group description 
Participants randomized to receive openlabel 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.  
Reporting group title 
Risankizumab


Reporting group description 
Participants randomized to receive openlabel risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16.  



End points reporting groups


Reporting group title 
Fumaderm


Reporting group description 
Participants randomized to receive openlabel 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.  
Reporting group title 
Risankizumab


Reporting group description 
Participants randomized to receive openlabel risankizumab 150 mg by subcutaneous injection at Weeks 0, 4, and 16. 


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 5point 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 followup visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.


End point type 
Primary


End point timeframe 
Week 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue was calculated from the CochranMantelHaenszel (CMH) test adjusted for strata (prior phototherapy [yes/no]).


Comparison groups 
Fumaderm v Risankizumab


Number of subjects included in analysis 
120


Analysis specification 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
73.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
61.3  
upper limit 
85.3 


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 5point 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 followup visit) I PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 4




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
46.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
32.8  
upper limit 
60.8 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 8




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
63.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
50.2  
upper limit 
76.6 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 12




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
53.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
40.4  
upper limit 
65.7 


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 5point 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 followup visit) I PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 16




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
39.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
27.3  
upper limit 
51.9 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 20




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
36.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
24.1  
upper limit 
48.5 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
46.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
33.7  
upper limit 
59 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 4




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
= 0.047  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
9.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.1  
upper limit 
19.7 


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 5point 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 followup visit) I PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 8




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
66.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
53.8  
upper limit 
79.5 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 12




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
66.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
53.3  
upper limit 
79.9 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 16




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
66.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
53.8  
upper limit 
79.5 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 20




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
56.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
43  
upper limit 
70 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 24




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

Statistical analysis title 
Statistical Analysis 1  
Comparison groups 
Fumaderm v Risankizumab


Number of subjects included in analysis 
120


Analysis specification 
Prespecified


Analysis type 
other ^{[27]}  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
64.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
52.5  
upper limit 
77.2  
Notes [27]  Pvalue was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]). 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 4




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
= 0.392  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
1.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.1  
upper limit 
5.4 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 8




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
36.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
23.8  
upper limit 
49.3 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 12




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 

Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
56.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
43.2  
upper limit 
70 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 16




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
64.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
51.5  
upper limit 
78.3 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 20




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
66.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
53.3  
upper limit 
79.8 


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 5point 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 followup visit) I PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 4




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
= 0.991  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
0


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2  
upper limit 
2.1 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data


End point type 
Secondary


End point timeframe 
Week 8




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
= 0.323  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
3.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.2  
upper limit 
9.8 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 12




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
21.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10.4  
upper limit 
32.6 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 16




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
33.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
20.7  
upper limit 
45.5 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 20




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
41.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
27.3  
upper limit 
55.3 


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 5point 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 followup visit) / PASI score at Baseline * 100. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
44.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
30.9  
upper limit 
58.5 


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 5point 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
7.19


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
8.82  
upper limit 
5.56  
Variability estimate 
Standard error of the mean


Dispersion value 
0.825



End point title 
PASI: Change From Baseline to 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 5point 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. LOCF imputation was used for missing data.


End point type 
Secondary


End point timeframe 
Baseline, Week 8




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
9.58


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11.43  
upper limit 
7.72  
Variability estimate 
Standard error of the mean


Dispersion value 
0.936



End point title 
PASI: Change From Baseline to 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 5point 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. LOCF imputation was used for missing data.


End point type 
Secondary


End point timeframe 
Baseline, Week 12




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
8.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10.72  
upper limit 
6.87  
Variability estimate 
Standard error of the mean


Dispersion value 
0.972



End point title 
PASI: Change From Baseline to 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 5point 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. LOCF imputation was used for missing data.


End point type 
Secondary


End point timeframe 
Baseline, Week 16




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
7.78


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.68  
upper limit 
5.88  
Variability estimate 
Standard error of the mean


Dispersion value 
0.958



End point title 
PASI: Change From Baseline to 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 5point 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. LOCF imputation was used for missing data.


End point type 
Secondary


End point timeframe 
Baseline, Week 20




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
7.89


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10.07  
upper limit 
5.71  
Variability estimate 
Standard error of the mean


Dispersion value 
1.101



End point title 
PASI: Change From Baseline to 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 5point 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. LOCF imputation was used for missing data.


End point type 
Secondary


End point timeframe 
Baseline, Week 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
8.39


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10.71  
upper limit 
6.06  
Variability estimate 
Standard error of the mean


Dispersion value 
1.175



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 5point 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
29.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
17.1  
upper limit 
42.4 


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 5point 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
66.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
53.4  
upper limit 
80 


End point title 
Percentage of Participants Achieving sPGA Score of Clear or Almost 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 5point 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
56.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
42.7  
upper limit 
70.8 


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 5point 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
59.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
46.3  
upper limit 
73.6 


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 5point 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
44.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
30.8  
upper limit 
59.1 


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 5point 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
55


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
41.2  
upper limit 
68.8 


End point title 
Percentage of Participants Achieving sPGA Score of 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 5point 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
= 0.392  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
1.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.1  
upper limit 
5.4 


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 5point 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
= 0.048  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
8.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.1  
upper limit 
16.7 


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 5point 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
= 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
18.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
7.1  
upper limit 
29.5 


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 5point 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
33


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
20.2  
upper limit 
45.9 


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 5point 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
41.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
27.3  
upper limit 
55.3 


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 5point 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
46.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
32.6  
upper limit 
60.1 


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 5point 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
= 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
19.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
7.6  
upper limit 
31.9 


End point title 
Percentage of Participants With PSS Score of 0 at Week 24  
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 5point 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 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
38.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
25  
upper limit 
51.5 


End point title 
PSS Total Score: Change From Baseline to 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 5point 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. LOCF imputation was used for missing data.


End point type 
Secondary


End point timeframe 
Baseline, Week 16




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues were calculated by stratified van Elteren test.


Comparison groups 
Fumaderm v Risankizumab


Number of subjects included in analysis 
114


Analysis specification 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
van Elteren test  
Parameter type 
Least Squares Mean Difference  
Point estimate 
3.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
4.5  
upper limit 
2  
Variability estimate 
Standard error of the mean


Dispersion value 
0.63



End point title 
PSS Total Score: Change From Baseline to Week 24  
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 5point 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. LOCF imputation was used for missing data.


End point type 
Secondary


End point timeframe 
Baseline, Week 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues were calculated by stratified van Elteren test.


Comparison groups 
Fumaderm v Risankizumab


Number of subjects included in analysis 
115


Analysis specification 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
van Elteren test  
Parameter type 
Least Squares Mean Difference  
Point estimate 
3.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
5.1  
upper limit 
2.7  
Variability estimate 
Standard error of the mean


Dispersion value 
0.59



End point title 
Summary of Patient Benefit Index (PBI) at Week 16  
End point description 
The PBI is a patientreported 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 5point 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
1.146


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.764  
upper limit 
1.528 


End point title 
Summary of PBI at Week 24  
End point description 
The PBI is a patientreported outcome instrument that assesses the benefit of psoriasis treatment. The PBI is a patientreported 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 5point 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
1.32


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.936  
upper limit 
1.704 


End point title 
Clinical Severity of Nail Psoriasis (NAPPACLIN) Total Score: Change From Baseline to Week 16  
End point description 
The NAPPACLIN 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). NAPPACLIN has been developed from the Nail Psoriasis Severity Index (NAPSI) score, a nail psoriasisspecific 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 NAPPACLIN 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 NAPPACLIN 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
2.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.6  
upper limit 
1.1  
Variability estimate 
Standard error of the mean


Dispersion value 
0.63



End point title 
NAPPACLIN Total Score: Change From Baseline to Week 24  
End point description 
The NAPPACLIN 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). NAPPACLIN has been developed from the NAPSI score, a nail psoriasisspecific 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 NAPPACLIN 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 NAPPACLIN 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
4.3  
upper limit 
1.6  
Variability estimate 
Standard error of the mean


Dispersion value 
0.66



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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
= 0.352  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.29


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.9  
upper limit 
0.32  
Variability estimate 
Standard error of the mean


Dispersion value 
0.307



End point title 
PPASI: Change From Baseline to Week 24  
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 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
= 0.315  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.88  
upper limit 
0.29  
Variability estimate 
Standard error of the mean


Dispersion value 
0.296



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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
4.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
6.9  
upper limit 
2.7  
Variability estimate 
Standard error of the mean


Dispersion value 
1.06



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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
9.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
12.6  
upper limit 
6.1  
Variability estimate 
Standard error of the mean


Dispersion value 
1.64



End point title 
BSA Affected by Psoriasis: Change From Baseline to Week 12  
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 12




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
10.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
13.2  
upper limit 
7.2  
Variability estimate 
Standard error of the mean


Dispersion value 
1.51



End point title 
BSA Affected by Psoriasis: Change From Baseline to Week 16  
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 16




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
9.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
12.8  
upper limit 
6.8  
Variability estimate 
Standard error of the mean


Dispersion value 
1.51



End point title 
BSA Affected by Psoriasis: Change From Baseline to Week 20  
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 20




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
9.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
12.4  
upper limit 
6.8  
Variability estimate 
Standard error of the mean


Dispersion value 
1.39



End point title 
BSA Affected by Psoriasis: Change From Baseline to Week 24  
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 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
10


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
12.9  
upper limit 
7.1  
Variability estimate 
Standard error of the mean


Dispersion value 
1.47



End point title 
Short Form Health Survey 36, Version 2 (SF36 V2) Physical Component Summary (PCS) Score: Change From Baseline to Week 16  
End point description 
The SF36 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 14 comprise the physical component of the SF36. Scores on each item were summed and averaged (PCS Score; range = 0100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.


End point type 
Secondary


End point timeframe 
Baseline, Week 16




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
= 0.002  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
4.49


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.74  
upper limit 
7.23  
Variability estimate 
Standard error of the mean


Dispersion value 
1.385



End point title 
SF36 V2 PCS Score: Change From Baseline to Week 24  
End point description 
The SF36 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 14 comprise the physical component of the SF36. Scores on each item were summed and averaged (PCS Score; range = 0100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.


End point type 
Secondary


End point timeframe 
Baseline, Week 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
4.63


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.01  
upper limit 
7.25  
Variability estimate 
Standard error of the mean


Dispersion value 
1.322



End point title 
SF36 V2 Mental Component Summary (MCS) Score: Change From Baseline: to Week 16  
End point description 
The SF36 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 58 comprise the mental component of the SF36. Scores on each item were summed and averaged (MCS Score; range = 0100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.


End point type 
Secondary


End point timeframe 
Baseline, Week 16




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
6.66


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.11  
upper limit 
10.2  
Variability estimate 
Standard error of the mean


Dispersion value 
1.787



End point title 
SF36 V2 MCS Score: Change From Baseline to Week 24  
End point description 
The SF36 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 58 comprise the mental component of the SF36. Scores on each item were summed and averaged (MCS Score; range = 0100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data


End point type 
Secondary


End point timeframe 
Baseline, Week 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
7.85


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
4.31  
upper limit 
11.38  
Variability estimate 
Standard error of the mean


Dispersion value 
1.784



End point title 
Patient's Global Assessment (PtGA): Change From Baseline to Week 16  
End point description 
The PtGA is a patientreported outcome instrument to assess the patient's assessment of disease severity. This selfreported measure is used to assess disease activity using a 4point 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.2  
upper limit 
0.7  
Variability estimate 
Standard error of the mean


Dispersion value 
0.13



End point title 
PtGA: Change From Baseline to Week 24  
End point description 
The PtGA is a patientreported outcome instrument to assess the patient's assessment of disease severity. This selfreported measure is used to assess disease activity using a 4point 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 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.3  
upper limit 
0.8  
Variability estimate 
Standard error of the mean


Dispersion value 
0.13



End point title 
Hospital Anxiety and Depression Scale (HADS) Total ScoreAnxiety: Change From Baseline to Week 16  
End point description 
The HADS was a patientreported 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 021, 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.2  
upper limit 
0.9  
Variability estimate 
Standard error of the mean


Dispersion value 
0.57



End point title 
HADS Total ScoreAnxiety: Change From Baseline to Week 24  
End point description 
The HADS was a patientreported 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 021, 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
2.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.5  
upper limit 
1.1  
Variability estimate 
Standard error of the mean


Dispersion value 
0.59



End point title 
HADS Total ScoreDepression: Change From Baseline to Week 16  
End point description 
The HADS was a patientreported 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 021, 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
3.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
4.3  
upper limit 
1.9  
Variability estimate 
Standard error of the mean


Dispersion value 
0.61



End point title 
HADS Total ScoreDepression: Change From Baseline to Week 24  
End point description 
The HADS was a patientreported 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 021, 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
3.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
4.4  
upper limit 
1.8  
Variability estimate 
Standard error of the mean


Dispersion value 
0.65



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 10question 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 01 = no effect on patient's life, 25 = small effect, 610 = moderate effect, 1120 = very large effect, and 2130 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5point change from baseline is considered a clinically important difference. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 16




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
38.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
23.6  
upper limit 
53.1 


End point title 
Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 24  
End point description 
The DLQI is a 10question 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 01 = no effect on patient's life, 25 = small effect, 610 = moderate effect, 1120 = very large effect, and 2130 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5point change from baseline is considered a clinically important difference. NRI was used for missing data.


End point type 
Secondary


End point timeframe 
Week 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalue 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
CochranMantelHaenszel  
Parameter type 
Adjusted percentage difference  
Point estimate 
56.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
42.7  
upper limit 
70.9 


End point title 
DLQI Total Score: Change From Baseline to Week 16  
End point description 
The DLQI is a 10question 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 01 = no effect on patient's life, 25 = small effect, 610 = moderate effect, 1120 = very large effect, and 2130 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data.


End point type 
Secondary


End point timeframe 
Baseline, Week 16




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
7.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.6  
upper limit 
5.1  
Variability estimate 
Standard error of the mean


Dispersion value 
1.15



End point title 
DLQI: Change From Baseline to Week 24  
End point description 
The DLQI is a 10question 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 01 = no effect on patient's life, 25 = small effect, 610 = moderate effect, 1120 = very large effect, and 2130 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data.


End point type 
Secondary


End point timeframe 
Baseline, Week 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
7.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.7  
upper limit 
5.5  
Variability estimate 
Standard error of the mean


Dispersion value 
1.06



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 (90100% 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
6.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9  
upper limit 
4.1  
Variability estimate 
Standard error of the mean


Dispersion value 
1.23



End point title 
PSSI: Change From Baseline at Week 24  
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 (90100% 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 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
8.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11.1  
upper limit 
5  
Variability estimate 
Standard error of the mean


Dispersion value 
1.53



End point title 
European Quality of Life 5 Dimensions (EQ5D5L) Total Score: Change From Baseline to Week 16  
End point description 
The EQ5D5L is a standardized nondisease specific instrument for describing and valuing healthrelated quality of life. The EQ5D5L 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 EQ505L 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 EQ5D5L total score indicates improvement. LOCF imputation was used for missing data.


End point type 
Secondary


End point timeframe 
Baseline, Week 16




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.087


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.045  
upper limit 
0.13  
Variability estimate 
Standard error of the mean


Dispersion value 
0.0215



End point title 
EQ5D5L Total Score: Change From Baseline to Week 24  
End point description 
The EQ5D5L is a standardized nondisease specific instrument for describing and valuing healthrelated quality of life. The EQ5D5L 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 EQ5D5L 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 EQ5D5L total score indicates improvement. LOCF imputation was used for missing data.


End point type 
Secondary


End point timeframe 
Baseline, Week 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
= 0.002  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.059


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.022  
upper limit 
0.096  
Variability estimate 
Standard error of the mean


Dispersion value 
0.0186



End point title 
EQ5D5L Visual Analog Scale (VAS): Change From Baseline to Week 16  
End point description 
The EQ5D5L is a standardized nondisease specific instrument for describing and valuing healthrelated quality of life. The EQ5D5L VAS records the participant's selfrated 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 EQ5D5L VAS score indicates improvement. LOCF imputation was used for missing data.


End point type 
Secondary


End point timeframe 
Baseline, Week 16




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
14.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.4  
upper limit 
20.5  
Variability estimate 
Standard error of the mean


Dispersion value 
2.8



End point title 
EQ5D5L VAS: Change From Baseline to Week 24  
End point description 
The EQ5D5L is a standardized nondisease specific instrument for describing and valuing healthrelated quality of life. The EQ5D5L VAS records the participant's selfrated 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 EQ5D5L VAS score indicates improvement. LOCF imputation was used for missing data.


End point type 
Secondary


End point timeframe 
Baseline, Week 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
16.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11.4  
upper limit 
22.2  
Variability estimate 
Standard error of the mean


Dispersion value 
2.73



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 (04) and a nail bed score (04). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (08). 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
11.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
16.6  
upper limit 
6.2  
Variability estimate 
Standard error of the mean


Dispersion value 
2.64



End point title 
NAPSI: Change From Baseline to Week 24  
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 (04) and a nail bed score (04). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (08). 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 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
13.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
19.1  
upper limit 
8.4  
Variability estimate 
Standard error of the mean


Dispersion value 
2.7



End point title 
Participants With Baseline NAPSI >0: 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. 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




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
75


Analysis specification 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
17.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
24.8  
upper limit 
9.8  
Variability estimate 
Standard error of the mean


Dispersion value 
3.75



End point title 
Participants With Baseline NAPSI >0: Change From Baseline to Week 24  
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. 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 24




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

Statistical analysis title 
Statistical Analysis 1  
Statistical analysis description 
Pvalues 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 
75


Analysis specification 
Prespecified


Analysis type 
other  
Pvalue 
< 0.001  
Method 
ANCOVA  
Parameter type 
Least Squares Mean Difference  
Point estimate 
21.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
28.8  
upper limit 
14.2  
Variability estimate 
Standard error of the mean


Dispersion value 
3.66



Adverse events information


Timeframe for reporting adverse events 
Treatmentemergent 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 used for adverse event reporting


Dictionary name 
MedDRA  
Dictionary version 
21.0


Reporting groups


Reporting group title 
Fumaderm


Reporting group description 
Participants randomized to receive openlabel 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 openlabel risankizumab 150 mg at Weeks 0, 4, and 16.  


Frequency threshold for reporting nonserious adverse events: 5%  



Substantial protocol amendments (globally) 

Were there any global substantial amendments to the protocol? Yes  
Date 
Amendment 

13 Mar 2017 
Revisions included changing the pharmacokinetic and antidrug 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 UVtherapy and balneotherapy are considered systemic therapy when associated with UVsensitizing agents and are not considered systemic therapy when they are not associated with UVsensitizing 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 NAPPACLIN: 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 eCRF 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 UVtherapy or balneotherapy) notassociated with systemic UVsensitizing 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, αhydroxy acid, fruit acids) are prohibited from 14 days prior to Screening to 14 days prior to Baseline. The halflife 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.


Interruptions (globally) 

Were there any global interruptions to the trial? No  
Limitations and caveats 

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.  
None reported 