Clinical Trial Results:
A Phase 2 Multicenter, Randomized, Placebo- and Active-Comparator-Controlled, Dose-Ranging Trial to Evaluate CNTO1959 for the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis (X-PLORE)

Due to a system error, the data reported in v1 is not correct and has been removed from public view.

Summary
EudraCT number	2011-001066-17
Trial protocol	DE BE
Global end of trial date	05 Aug 2013

Results information
Results version number	v2(current)
This version publication date	15 Jul 2016
First version publication date	15 Aug 2015
Other versions	v1 (removed from public view)
Version creation reason	Correction of full data set Review of data

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

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Trial information

Top of page

Sponsor protocol code

CNTO1959PSO2001

ISRCTN number

US NCT number

NCT01483599

WHO universal trial number (UTN)

Sponsor organisation name

Janssen-Cilag International NV

Sponsor organisation address

Turnhoutseweg 30, Beerse, Belgium, B-2340

Public contact

Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com

Scientific contact

Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com

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

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

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

Analysis stage

Final

Date of interim/final analysis

20 Feb 2014

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

05 Aug 2013

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study was to evaluate the efficacy and safety of CNTO 1959 in the treatment of participants with moderate to severe plaque psoriasis.

Protection of trial subjects

Safety evaluation of this study included physical examinations, detection of injection site and allergic reactions, electrocardiograms (ECGs), clinical laboratory tests, vital signs and concomitant medications. Safety was to be monitored through Week 52 for all participants. Adverse events (AEs) were reported throughout the study period.

Background therapy

None

Evidence for comparator

Adalimumab: Particpants receiving 80 mg adalimumab at Week 0, 40 mg at Week 1 and every other week to Week 39 as active comparator.

Actual start date of recruitment

25 Oct 2011

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 5

Country: Number of subjects enrolled

Canada: 83

Country: Number of subjects enrolled

Germany: 23

Country: Number of subjects enrolled

Poland: 55

Country: Number of subjects enrolled

United States: 127

Worldwide total number of subjects

293

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

272

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

A total of 394 participants were screened, however 293 participants were randomized to receive treatment.

Period 1 title

Controlled period (Week 0 - 16)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Assessor

Are arms mutually exclusive

Yes

Placebo (CP)

Arm description

Participants received placebo at Week 0, 4 and 8.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received placebo at Week 0, 4 and 8.

5 mg CNTO1959 (CP)

Arm description

Participants received CNTO1959 5 milligram (mg) subcutaneously at Weeks 0 and 4.

Arm type

Experimental

Investigational medicinal product name

CNTO 1959

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received CNTO1959 5 milligram (mg) subcutaneously at Weeks 0 and 4.

15 mg CNTO1959 (CP)

Arm description

Participants received CNTO1959 15 milligram (mg) subcutaneously at Weeks 0 and 8.

Arm type

Experimental

Investigational medicinal product name

CNTO 1959

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received CNTO1959 15 milligram (mg) subcutaneously at Weeks 0 and 8.

50 mg CNTO1959 (CP)

Arm description

Participants received CNTO1959 50 milligram (mg) subcutaneously at weeks 0 and 4.

Arm type

Experimental

Investigational medicinal product name

CNTO 1959

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received CNTO1959 50 milligram (mg) subcutaneously at weeks 0 and 4.

100 mg CNTO1959 (CP)

Arm description

Participants received CNTO1959 100 milligram (mg) subcutaneously at weeks 0 and 8.

Arm type

Experimental

Investigational medicinal product name

CNTO 1959

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received CNTO1959 100 milligram (mg) subcutaneously at weeks 0 and 8.

200 mg CNTO1959 (CP)

Arm description

Participants received CNTO1959 200 milligram (mg) subcutaneously at weeks 0 and 4.

Arm type

Experimental

Investigational medicinal product name

CNTO 1959

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received CNTO1959 200 milligram (mg) subcutaneously at weeks 0 and 4.

Adalimumab (CP)

Arm description

Adalimumab (Week 0 - 16, Open label): Participants received Adalimumab 80 milligram (mg) as open label at week 0 followed by 40 mg at week 1 and every second week up to week 15. Efficacy for this arm was evaluated by a blinded assessor.

Arm type

Active comparator

Investigational medicinal product name

Adalimumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received Adalimumab 80 milligram (mg) at week 0 followed by 40 mg at week 1 and every second week up to week 15 (i.e., Weeks 3, 5, 7, etc.)

Number of subjects in period 1	Placebo (CP)	5 mg CNTO1959 (CP)	15 mg CNTO1959 (CP)	50 mg CNTO1959 (CP)	100 mg CNTO1959 (CP)	200 mg CNTO1959 (CP)	Adalimumab (CP)
Started	42	41	41	42	42	42	43
Completed	39	38	41	39	40	38	39
Not completed	3	3	0	3	2	4	4
Adverse event, non-fatal	2	-	-	1	1	4	3
Other	-	2	-	1	1	-	-
Lost to follow-up	-	1	-	1	-	-	1
Lack of efficacy	1	-	-	-	-	-	-

Period 2 title

After Controlled period (Week 16 - 52)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Assessor

Are arms mutually exclusive

Yes

Placebo --> 100 mg CNTO1959 (after CP)

Arm description

Participants received 100 mg CNTO1959 at Week 16 and every 8 weeks (q8w) thereafter through Week 40.

Arm type

Experimental

Investigational medicinal product name

CNTO1959

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received 100 mg CNTO1959 at Week 16 and every 8 weeks (q8w) thereafter through Week 40.

5 mg CNTO1959 (after CP)

Arm description

Participants received CNTO1959 5 milligram (mg) subcutaneously at week 16, then every 12 weeks through Week 40.

Arm type

Experimental

Investigational medicinal product name

CNTO 1959

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received CNTO1959 5 milligram (mg) subcutaneously at week 16, then every 12 weeks through Week 40.

15 mg CNTO1959 (after CP)

Arm description

Participants received CNTO1959 15 milligram (mg) subcutaneously at week 16 and then every 8 weeks through Week 40.

Arm type

Experimental

Investigational medicinal product name

CNTO 1959

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received CNTO1959 15 milligram (mg) subcutaneously at week 16 and then every 8 weeks through Week 40.

50 mg CNTO1959 (after CP)

Arm description

Participants received CNTO1959 50 mg subcutaneously at week 16, then every 12 weeks through Week 40.

Arm type

Experimental

Investigational medicinal product name

CNTO 1959

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received CNTO1959 50 mg subcutaneously at week 16, then every 12 weeks through Week 40.

100 mg CNTO1959 (after CP)

Arm description

Participants received CNTO1959 100 milligram (mg) subcutaneously at week 16, then every 8 weeks through Week 40.

Arm type

Experimental

Investigational medicinal product name

CNTO 1959

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received CNTO1959 100 milligram (mg) subcutaneously at week 16, then every 8 weeks through Week 40.

200 mg CNTO1959 (after CP)

Arm description

Participants received CNTO1959 200 mg subcutaneously at week 16, then every 12 weeks through Week 40.

Arm type

Experimental

Investigational medicinal product name

CNTO 1959

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received CNTO1959 200 mg subcutaneously at week 16, then every 12 weeks through Week 40.

Adalimumab (after CP)

Arm description

Participants received Adalimumab 40 milligram (mg) at week 17 and every second week through Week 39 (i.e., Weeks 19, 21, 23, etc.)

Arm type

Experimental

Investigational medicinal product name

Adalimumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received Adalimumab 40 milligram (mg) at week 17 and every second week through Week 39 (i.e., Weeks 19, 21, 23, etc.)

Number of subjects in period 2	Placebo --> 100 mg CNTO1959 (after CP)	5 mg CNTO1959 (after CP)	15 mg CNTO1959 (after CP)	50 mg CNTO1959 (after CP)	100 mg CNTO1959 (after CP)	200 mg CNTO1959 (after CP)	Adalimumab (after CP)
Started	39	38	41	39	40	38	39
Completed	37	29	37	37	39	35	32
Not completed	2	9	4	2	1	3	7
Adverse event, serious fatal	-	1	-	-	-	-	-
Consent withdrawn by subject	-	1	-	2	-	-	1
Adverse event, non-fatal	1	1	-	-	-	1	1
Other	1	-	4	-	-	1	-
Lost to follow-up	-	1	-	-	1	-	1
Lack of efficacy	-	5	-	-	-	1	4

Baseline characteristics

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Reporting group title

Placebo (CP)

Reporting group description

Participants received placebo at Week 0, 4 and 8.

Reporting group title

5 mg CNTO1959 (CP)

Reporting group description

Participants received CNTO1959 5 milligram (mg) subcutaneously at Weeks 0 and 4.

Reporting group title

15 mg CNTO1959 (CP)

Reporting group description

Participants received CNTO1959 15 milligram (mg) subcutaneously at Weeks 0 and 8.

Reporting group title

50 mg CNTO1959 (CP)

Reporting group description

Participants received CNTO1959 50 milligram (mg) subcutaneously at weeks 0 and 4.

Reporting group title

100 mg CNTO1959 (CP)

Reporting group description

Participants received CNTO1959 100 milligram (mg) subcutaneously at weeks 0 and 8.

Reporting group title

200 mg CNTO1959 (CP)

Reporting group description

Participants received CNTO1959 200 milligram (mg) subcutaneously at weeks 0 and 4.

Reporting group title

Adalimumab (CP)

Reporting group description

Reporting group values	Placebo (CP)	5 mg CNTO1959 (CP)	15 mg CNTO1959 (CP)	50 mg CNTO1959 (CP)	100 mg CNTO1959 (CP)	200 mg CNTO1959 (CP)	Adalimumab (CP)	Total
Number of subjects	42	41	41	42	42	42	43	293
Title for AgeCategorical
Units: subjects
Children (2-11 years)	0	0	0	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0	0	0	0
Adults (18-64 years)	41	40	39	41	36	40	35	272
From 65 to 84 years	1	1	2	1	6	2	8	21
85 years and over	0	0	0	0	0	0	0	0
Title for AgeContinuous
Units: years
arithmetic mean (standard deviation)	45 ± 11.97	45.2 ± 13.92	43.8 ± 13.5	42.6 ± 12.14	45.3 ± 13.72	45.1 ± 10.96	47.5 ± 14.91	-
Title for Gender
Units: subjects
Female	14	13	13	12	10	11	13	86
Male	28	28	28	30	32	31	30	207

End points

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Reporting group title

Placebo (CP)

Reporting group description

Participants received placebo at Week 0, 4 and 8.

Reporting group title

5 mg CNTO1959 (CP)

Reporting group description

Participants received CNTO1959 5 milligram (mg) subcutaneously at Weeks 0 and 4.

Reporting group title

15 mg CNTO1959 (CP)

Reporting group description

Participants received CNTO1959 15 milligram (mg) subcutaneously at Weeks 0 and 8.

Reporting group title

50 mg CNTO1959 (CP)

Reporting group description

Participants received CNTO1959 50 milligram (mg) subcutaneously at weeks 0 and 4.

Reporting group title

100 mg CNTO1959 (CP)

Reporting group description

Participants received CNTO1959 100 milligram (mg) subcutaneously at weeks 0 and 8.

Reporting group title

200 mg CNTO1959 (CP)

Reporting group description

Participants received CNTO1959 200 milligram (mg) subcutaneously at weeks 0 and 4.

Reporting group title

Adalimumab (CP)

Reporting group description

Reporting group title

Placebo --> 100 mg CNTO1959 (after CP)

Reporting group description

Participants received 100 mg CNTO1959 at Week 16 and every 8 weeks (q8w) thereafter through Week 40.

Reporting group title

5 mg CNTO1959 (after CP)

Reporting group description

Participants received CNTO1959 5 milligram (mg) subcutaneously at week 16, then every 12 weeks through Week 40.

Reporting group title

15 mg CNTO1959 (after CP)

Reporting group description

Participants received CNTO1959 15 milligram (mg) subcutaneously at week 16 and then every 8 weeks through Week 40.

Reporting group title

50 mg CNTO1959 (after CP)

Reporting group description

Participants received CNTO1959 50 mg subcutaneously at week 16, then every 12 weeks through Week 40.

Reporting group title

100 mg CNTO1959 (after CP)

Reporting group description

Participants received CNTO1959 100 milligram (mg) subcutaneously at week 16, then every 8 weeks through Week 40.

Reporting group title

200 mg CNTO1959 (after CP)

Reporting group description

Participants received CNTO1959 200 mg subcutaneously at week 16, then every 12 weeks through Week 40.

Reporting group title

Adalimumab (after CP)

Reporting group description

Participants received Adalimumab 40 milligram (mg) at week 17 and every second week through Week 39 (i.e., Weeks 19, 21, 23, etc.)

Subject analysis set title

Randomised Population

Subject analysis set type

Full analysis

Subject analysis set description

All randomized subjects were analyzed according to their assigned treatment group regardless of the actual treatment received (ie, adalimumab, placebo, CNTO 1959). For subjects randomized to placebo, only subjects who crossed over to receive CNTO 1959 100 mg q8w at Week 16 were included in the efficacy summaries after Week 16.

Primary: Number of Participants With Cleared or Minimal (0 or 1) Physician's Global Assessment (PGA) Score at Week 16

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End point title

Number of Participants With Cleared or Minimal (0 or 1) Physician's Global Assessment (PGA) Score at Week 16

End point description

Percentage of participants with cleared or minimal (0 or 1) at Week 16 was reported. The PGA score is a numeric scale which is completed by the physician and was designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded as: 0=cleared, 1=minimal, 2=mild, 3=moderate,4=marked, and 5=severe.

End point type

Primary

End point timeframe

Up to Week 16

End point values	Placebo (CP)	5 mg CNTO1959 (CP)	15 mg CNTO1959 (CP)	50 mg CNTO1959 (CP)	100 mg CNTO1959 (CP)	200 mg CNTO1959 (CP)	Adalimumab (CP)
Number of subjects analysed	42 ^[1]	41 ^[2]	41 ^[3]	42 ^[4]	42 ^[5]	42 ^[6]	43 ^[7]
Units: Participants	3	14	25	33	36	35	25

Notes
[1] - Randomised Population
[2] - Randomised Population
[3] - Randomised Population
[4] - Randomised Population
[5] - Randomised Population
[6] - Randomised Population
[7] - Randomised Population

Statistical analysis 1

Comparison groups

Placebo (CP) v 5 mg CNTO1959 (CP)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 2

Comparison groups

Placebo (CP) v 15 mg CNTO1959 (CP)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 3

Comparison groups

Placebo (CP) v 50 mg CNTO1959 (CP)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 4

Comparison groups

Placebo (CP) v 100 mg CNTO1959 (CP)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Statistical analysis 5

Comparison groups

Placebo (CP) v 200 mg CNTO1959 (CP)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Cochran-Mantel-Haenszel

Confidence interval

Secondary: Number of Participants With 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score

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End point title

Number of Participants With 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score

End point description

Percentage of participants with >=75% improvement in PASI score at Week 16 from Baseline was reported. PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).

End point type

Secondary

End point timeframe

Up to week 16

End point values	Placebo (CP)	5 mg CNTO1959 (CP)	15 mg CNTO1959 (CP)	50 mg CNTO1959 (CP)	100 mg CNTO1959 (CP)	200 mg CNTO1959 (CP)	Adalimumab (CP)
Number of subjects analysed	42 ^[8]	41 ^[9]	41 ^[10]	42 ^[11]	42 ^[12]	42 ^[13]	43 ^[14]
Units: Participants	2	18	31	34	33	34	30

Notes
[8] - Randomised Population
[9] - Randomised Population
[10] - Randomised Population
[11] - Randomised Population
[12] - Randomised Population
[13] - Randomised Population
[14] - Randomised Population

Statistical analysis 1

Comparison groups

Placebo (CP) v 5 mg CNTO1959 (CP)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[15]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[15] - p-Value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (≤ 90 kg, > 90 kg).

Statistical analysis 2

Comparison groups

Placebo (CP) v 15 mg CNTO1959 (CP)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[16]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[16] - P-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (≤ 90 kg, > 90 kg).

Statistical analysis 3

Comparison groups

Placebo (CP) v 50 mg CNTO1959 (CP)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[17]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[17] - P-value is based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (≤ 90 kg, > 90 kg).

Statistical analysis 4

Comparison groups

Placebo (CP) v 100 mg CNTO1959 (CP)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[18]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[18] - P-value is based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (≤ 90 kg, > 90 kg).

Statistical Analysis 5

Comparison groups

Placebo (CP) v 200 mg CNTO1959 (CP)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[19]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[19] - P-value is based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (≤ 90 kg, > 90 kg).

Secondary: Percentage of Participants Achieving the Physician's Global Assessment (PGA) score of cleared (0) or minimal (1) at Week 16 and Week 40

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End point title

Percentage of Participants Achieving the Physician's Global Assessment (PGA) score of cleared (0) or minimal (1) at Week 16 and Week 40 ^[20]

End point description

Difference and the 95% confidence intervals in the percentage of participants achieving a PGA score of cleared (0) or minimal (1) at Week 16 and Week 40 between each of the CNTO 1959 treatment groups and the adalimumab treatment group was calculated. The PGA score is a numeric scale which was completed by the physician and was designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions was graded as: 0=cleared, 1=minimal, 2=mild, 3=moderate,4=marked, and 5=severe. The proportion of subjects achieving a PGA score of cleared (0) or minimal (1) was lower in theCNTO 1959 5 mg q12w group as compared with the adalimumab group, however the 95% CI incudes 0. Here 'n' signifies the number of participants evaluated at this time point.

End point type

Secondary

End point timeframe

Weeks 16 and 40

Notes
[20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Subjects randomized in placebo group were not evaluated for this endpoint.

End point values	5 mg CNTO1959 (CP)	15 mg CNTO1959 (CP)	50 mg CNTO1959 (CP)	100 mg CNTO1959 (CP)	200 mg CNTO1959 (CP)	Adalimumab (CP)
Number of subjects analysed	41	41	42	42	42	43
Units: `Percentage of participants
number (confidence interval 95%)
Week 16 (n=41, 41, 42, 42, 42, 43)	-24 (-44 to -4)	2.8 (-17.9 to 23.5)	20.4 (1.5 to 39.3)	27.7 (9.8 to 45.6)	25.4 (7.2 to 43.6)	0 (0 to 0)
Week 40 (n=34, 37, 38, 39, 37,37)	-15.4 (-37.7 to 6.9)	10.8 (-10.7 to 32.4)	22.7 (1.8 to 43.6)	28.7 (8.5 to 49)	32.9 (13 to 52.8)	0 (0 to 0)

No statistical analyses for this end point

Secondary: Change from baseline in Dermatology Life Quality Index (DLQI) at Week 16

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End point title

Change from baseline in Dermatology Life Quality Index (DLQI) at Week 16

End point description

The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).

End point type

Secondary

End point timeframe

Up to week 16

End point values	Placebo (CP)	5 mg CNTO1959 (CP)	15 mg CNTO1959 (CP)	50 mg CNTO1959 (CP)	100 mg CNTO1959 (CP)	200 mg CNTO1959 (CP)	Adalimumab (CP)
Number of subjects analysed	42 ^[21]	39 ^[22]	41 ^[23]	40 ^[24]	40 ^[25]	39 ^[26]	39 ^[27]
Units: Units on a scale
arithmetic mean (standard deviation)	-2.3 ± 6.8	-6.2 ± 5.24	-10.3 ± 5.49	-11.1 ± 7.38	-10.8 ± 7.34	-11.4 ± 6.83	-10.1 ± 9

Notes
[21] - Randomised Population
[22] - Randomised Population
[23] - Randomised Population
[24] - Randomised Population
[25] - Randomised Population
[26] - Randomised Population
[27] - Randomised Population

Statistical analysis 1

Comparison groups

Placebo (CP) v 5 mg CNTO1959 (CP)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.008 ^[28]

Method

ANOVA

Confidence interval

Notes
[28] - P-value was based on the analysis of variance (ANOVA) on the van der Waerden normal scores adjusted with baseline weight (≤90 kg, >90 kg) as a binary covariate.

Statistical analysis 2

Comparison groups

Placebo (CP) v 15 mg CNTO1959 (CP)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[29]

Method

ANOVA

Confidence interval

Notes
[29] - P-value was based on the analysis of variance (ANOVA) on the van der Waerden normal scores adjusted with baseline weight (≤90 kg, >90 kg) as a binary covariate.

Statistical analysis 3

Comparison groups

Placebo (CP) v 50 mg CNTO1959 (CP)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[30]

Method

ANOVA

Confidence interval

Notes
[30] - P-value was based on the analysis of variance (ANOVA) on the van der Waerden normal scores adjusted with baseline weight (≤90 kg, >90 kg) as a binary covariate.

Statistical analysis 4

Comparison groups

Placebo (CP) v 100 mg CNTO1959 (CP)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[31]

Method

ANOVA

Confidence interval

Notes
[31] - P-value is based on the analysis of variance (ANOVA) on the van der Waerden normal scores adjusted with baseline weight (≤90 kg, >90 kg) as a binary covariate.

Statistical analysis 5

Comparison groups

200 mg CNTO1959 (CP) v Placebo (CP)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001 ^[32]

Method

ANOVA

Confidence interval

Notes
[32] - P-value is based on the analysis of variance (ANOVA) on the van der Waerden normal scores adjusted with baseline weight (≤90 kg, >90 kg) as a binary covariate.

Adverse events

Top of page

Timeframe for reporting adverse events

Baseline to followup (Week 52)

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

16.0

Reporting group title

Placebo (CP)

Reporting group description

Placebo (Week 0 - 16): Placebo SC administration at Week 0, Week 4, and Week 8

Reporting group title

5 mg CNTO1959 (CP)

Reporting group description

5 mg CNTO 1959 (Week 0 - 16): 5 mg CNTO1959 SC administration at Week 0 and Week 4

Reporting group title

15 mg CNTO1959 (CP)

Reporting group description

15 mg CNTO1959 (Week 0 - 16): 15 mg CNTO1959 SC administration at Week 0 and Week 8

Reporting group title

50 mg CNTO1959 (CP)

Reporting group description

50 mg CNTO1959 (Week 0 - 16): 50 mg CNTO1959 SC administration at Week 0 and Week 4

Reporting group title

100 mg CNTO1959 (CP)

Reporting group description

100 mg CNTO1959 (Week 0 - 16): 100 mg CNTO1959 SC administration at Week 0 and Week 8

Reporting group title

200 mg CNTO1959 (CP)

Reporting group description

200 mg CNTO1959 (Week 0 - 16): 200 mg CNTO1959 SC administration at Week 0 and Week 4

Reporting group title

Adalimumab (CP)

Reporting group description

Adalimumab (Week 0 - 16): Patients receiving 80 mg adalimumab at Week 0, 40 mg at Week 1 and every other week to week 15

Reporting group title

Placebo --> 100 mg CNTO1959 (after CP)

Reporting group description

Placebo --> 100 mg CNTO1959 (Week 16 - 40): Patients receiving Placebo at Week 0, 4, and week 8 --> receiving 100 mg CNTO1959 at Week 16 and every 8 weeks (q8w) thereafter through Week 40

Reporting group title

5 mg CNTO1959 (after CP)

Reporting group description

5 mg CNTO1959 (after CP): patients receiving 5 mg CNTO1959 at Week 0 and 4 --> receiving 5 mg CNTO1959 at Week 16 and every 12 weeks (q12w) thereafter through Week 40

Reporting group title

15 mg CNTO1959 (after CP)

Reporting group description

15 mg CNTO1959 (after CP): patients receiving 15 mg CNTO1959 at Week 0 and 8 --> receiving 15 mg CNTO1959 at Week 16 and every 8 weeks (q8w) thereafter through Week 40

Reporting group title

50 mg CNTO1959 (after CP)

Reporting group description

50 mg CNTO1959 (after CP): patients receiving 50 mg CNTO1959 at Week 0 and 4 --> receiving 50 mg CNTO1959 at Week 16 and every 12 weeks (q12w) thereafter through Week 40

Reporting group title

100 mg CNTO1959 (after CP)

Reporting group description

100 mg CNTO1959 (after CP): patients receiving 100 mg CNTO1959 at Week 0 and 8 --> receiving 100 mg CNTO1959 at Week 16 and every 8 weeks (q8w) thereafter through Week 40

Reporting group title

200 mg CNTO1959 (after CP)

Reporting group description

200 mg CNTO1959 (after CP): patients receiving 200 mg CNTO1959 at Week 0 and 4 --> receiving 200 mg CNTO1959 at Week 16 and every 12 weeks (q12w) thereafter through Week 40

Reporting group title

Adalimumab (after CP)

Reporting group description

Adalimumab (after CP): Patients receiving 80 mg adalimumab at Week 0, 40 mg at Week 1 and every other week to week 15 --> receiving 40 mg adalimumab at week 17 and every other week through Week 39

Placebo (CP)

5 mg CNTO1959 (CP)

15 mg CNTO1959 (CP)

50 mg CNTO1959 (CP)

100 mg CNTO1959 (CP)

200 mg CNTO1959 (CP)

Adalimumab (CP)

Placebo --> 100 mg CNTO1959 (after CP)

5 mg CNTO1959 (after CP)

15 mg CNTO1959 (after CP)

50 mg CNTO1959 (after CP)

100 mg CNTO1959 (after CP)

200 mg CNTO1959 (after CP)

Adalimumab (after CP)

Total subjects affected by serious adverse events

subjects affected / exposed

1 / 42 (2.38%)

0 / 41 (0.00%)

3 / 42 (7.14%)

0 / 42 (0.00%)

0 / 41 (0.00%)

1 / 43 (2.33%)

0 / 39 (0.00%)

2 / 38 (5.26%)

0 / 41 (0.00%)

0 / 39 (0.00%)

2 / 40 (5.00%)

0 / 38 (0.00%)

1 / 39 (2.56%)

number of deaths (all causes)

number of deaths resulting from adverse events

Vascular disorders

Haematoma

subjects affected / exposed

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 42 (0.00%)

0 / 41 (0.00%)

1 / 43 (2.33%)

0 / 39 (0.00%)

0 / 38 (0.00%)

0 / 41 (0.00%)

0 / 39 (0.00%)

0 / 40 (0.00%)

0 / 38 (0.00%)

0 / 39 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Atrial Flutter

subjects affected / exposed

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 42 (0.00%)

0 / 41 (0.00%)

1 / 43 (2.33%)

0 / 39 (0.00%)

0 / 38 (0.00%)

0 / 41 (0.00%)

0 / 39 (0.00%)

0 / 40 (0.00%)

0 / 38 (0.00%)

0 / 39 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Myocardial Infarction

subjects affected / exposed

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 43 (0.00%)

0 / 39 (0.00%)

1 / 38 (2.63%)

0 / 41 (0.00%)

0 / 39 (0.00%)

1 / 40 (2.50%)

0 / 38 (0.00%)

0 / 39 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

1 / 1

0 / 0

Nervous system disorders

Cerebrovascular Accident

subjects affected / exposed

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 43 (0.00%)

0 / 39 (0.00%)

0 / 38 (0.00%)

0 / 41 (0.00%)

0 / 39 (0.00%)

1 / 40 (2.50%)

0 / 38 (0.00%)

0 / 39 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Oesophagitis Haemorrhagic

subjects affected / exposed

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 43 (0.00%)

0 / 39 (0.00%)

0 / 38 (0.00%)

0 / 41 (0.00%)

0 / 39 (0.00%)

0 / 40 (0.00%)

0 / 38 (0.00%)

1 / 39 (2.56%)

occurrences causally related to treatment / all

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Umbilical Hernia

subjects affected / exposed

0 / 42 (0.00%)

0 / 41 (0.00%)

1 / 42 (2.38%)

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 43 (0.00%)

0 / 39 (0.00%)

0 / 38 (0.00%)

0 / 41 (0.00%)

0 / 39 (0.00%)

0 / 40 (0.00%)

0 / 38 (0.00%)

0 / 39 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Reproductive system and breast disorders

Uterine Prolapse

subjects affected / exposed

1 / 42 (2.38%)

0 / 41 (0.00%)

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 43 (0.00%)

0 / 39 (0.00%)

0 / 38 (0.00%)

0 / 41 (0.00%)

0 / 39 (0.00%)

0 / 40 (0.00%)

0 / 38 (0.00%)

0 / 39 (0.00%)

occurrences causally related to treatment / all

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Osteoarthritis

subjects affected / exposed

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 43 (0.00%)

0 / 39 (0.00%)

1 / 38 (2.63%)

0 / 41 (0.00%)

0 / 39 (0.00%)

0 / 40 (0.00%)

0 / 38 (0.00%)

0 / 39 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Appendicitis

subjects affected / exposed

0 / 42 (0.00%)

0 / 41 (0.00%)

1 / 42 (2.38%)

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 43 (0.00%)

0 / 39 (0.00%)

0 / 38 (0.00%)

0 / 41 (0.00%)

0 / 39 (0.00%)

0 / 40 (0.00%)

0 / 38 (0.00%)

0 / 39 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lung Abscess

subjects affected / exposed

0 / 42 (0.00%)

0 / 41 (0.00%)

1 / 42 (2.38%)

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 43 (0.00%)

0 / 39 (0.00%)

0 / 38 (0.00%)

0 / 41 (0.00%)

0 / 39 (0.00%)

0 / 40 (0.00%)

0 / 38 (0.00%)

0 / 39 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 43 (0.00%)

0 / 39 (0.00%)

0 / 38 (0.00%)

0 / 41 (0.00%)

0 / 39 (0.00%)

0 / 40 (0.00%)

0 / 38 (0.00%)

1 / 39 (2.56%)

occurrences causally related to treatment / all

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Hyperglycaemia

subjects affected / exposed

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 42 (0.00%)

0 / 41 (0.00%)

0 / 43 (0.00%)

0 / 39 (0.00%)

0 / 38 (0.00%)

0 / 41 (0.00%)

0 / 39 (0.00%)

0 / 40 (0.00%)

0 / 38 (0.00%)

1 / 39 (2.56%)

occurrences causally related to treatment / all

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

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

Non-serious adverse events	Placebo (CP)	5 mg CNTO1959 (CP)	15 mg CNTO1959 (CP)	50 mg CNTO1959 (CP)	100 mg CNTO1959 (CP)	200 mg CNTO1959 (CP)	Adalimumab (CP)	Placebo --> 100 mg CNTO1959 (after CP)	5 mg CNTO1959 (after CP)	15 mg CNTO1959 (after CP)	50 mg CNTO1959 (after CP)	100 mg CNTO1959 (after CP)	200 mg CNTO1959 (after CP)	Adalimumab (after CP)
Total subjects affected by non serious adverse events
subjects affected / exposed	13 / 42 (30.95%)	15 / 41 (36.59%)	10 / 41 (24.39%)	10 / 42 (23.81%)	7 / 42 (16.67%)	8 / 41 (19.51%)	10 / 43 (23.26%)	16 / 39 (41.03%)	12 / 38 (31.58%)	4 / 41 (9.76%)	11 / 39 (28.21%)	16 / 40 (40.00%)	12 / 38 (31.58%)	13 / 39 (33.33%)
Injury, poisoning and procedural complications
Muscle Strain
subjects affected / exposed	0 / 42 (0.00%)	0 / 41 (0.00%)	1 / 41 (2.44%)	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 41 (0.00%)	1 / 43 (2.33%)	2 / 39 (5.13%)	0 / 38 (0.00%)	0 / 41 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	0 / 38 (0.00%)	0 / 39 (0.00%)
occurrences all number	0	0	1	0	0	0	1	2	0	0	0	1	0	0
Vascular disorders
Hypertension
subjects affected / exposed	1 / 42 (2.38%)	1 / 41 (2.44%)	0 / 41 (0.00%)	3 / 42 (7.14%)	1 / 42 (2.38%)	1 / 41 (2.44%)	0 / 43 (0.00%)	1 / 39 (2.56%)	0 / 38 (0.00%)	0 / 41 (0.00%)	1 / 39 (2.56%)	2 / 40 (5.00%)	1 / 38 (2.63%)	1 / 39 (2.56%)
occurrences all number	1	1	0	4	1	1	0	1	0	0	1	2	1	1
Nervous system disorders
Headache
subjects affected / exposed	1 / 42 (2.38%)	3 / 41 (7.32%)	4 / 41 (9.76%)	1 / 42 (2.38%)	2 / 42 (4.76%)	0 / 41 (0.00%)	0 / 43 (0.00%)	1 / 39 (2.56%)	1 / 38 (2.63%)	0 / 41 (0.00%)	1 / 39 (2.56%)	2 / 40 (5.00%)	1 / 38 (2.63%)	0 / 39 (0.00%)
occurrences all number	1	3	4	1	2	0	0	1	2	0	1	2	1	0
General disorders and administration site conditions
Fatigue
subjects affected / exposed	3 / 42 (7.14%)	1 / 41 (2.44%)	1 / 41 (2.44%)	2 / 42 (4.76%)	0 / 42 (0.00%)	0 / 41 (0.00%)	0 / 43 (0.00%)	0 / 39 (0.00%)	0 / 38 (0.00%)	0 / 41 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 38 (2.63%)	0 / 39 (0.00%)
occurrences all number	3	1	1	4	0	0	0	0	0	0	0	0	1	0
Influenza Like Illness
subjects affected / exposed	0 / 42 (0.00%)	0 / 41 (0.00%)	1 / 41 (2.44%)	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 41 (0.00%)	0 / 43 (0.00%)	0 / 39 (0.00%)	0 / 38 (0.00%)	0 / 41 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	0 / 38 (0.00%)	2 / 39 (5.13%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	2
Injection Site Erythema
subjects affected / exposed	1 / 42 (2.38%)	0 / 41 (0.00%)	0 / 41 (0.00%)	0 / 42 (0.00%)	1 / 42 (2.38%)	1 / 41 (2.44%)	5 / 43 (11.63%)	0 / 39 (0.00%)	0 / 38 (0.00%)	0 / 41 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	0 / 38 (0.00%)	2 / 39 (5.13%)
occurrences all number	1	0	0	0	1	6	18	0	0	0	0	0	0	12
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	1 / 42 (2.38%)	1 / 41 (2.44%)	0 / 41 (0.00%)	0 / 42 (0.00%)	0 / 42 (0.00%)	2 / 41 (4.88%)	0 / 43 (0.00%)	0 / 39 (0.00%)	0 / 38 (0.00%)	0 / 41 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	2 / 38 (5.26%)	1 / 39 (2.56%)
occurrences all number	1	1	0	0	0	3	0	0	0	0	0	1	2	1
Oropharyngeal Pain
subjects affected / exposed	0 / 42 (0.00%)	0 / 41 (0.00%)	0 / 41 (0.00%)	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 41 (0.00%)	0 / 43 (0.00%)	0 / 39 (0.00%)	0 / 38 (0.00%)	0 / 41 (0.00%)	1 / 39 (2.56%)	2 / 40 (5.00%)	0 / 38 (0.00%)	0 / 39 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	2	0	0
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	4 / 42 (9.52%)	1 / 41 (2.44%)	0 / 41 (0.00%)	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 41 (0.00%)	0 / 43 (0.00%)	0 / 39 (0.00%)	0 / 38 (0.00%)	0 / 41 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	0 / 38 (0.00%)	1 / 39 (2.56%)
occurrences all number	4	1	0	0	0	0	0	0	0	0	0	0	0	1
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 42 (2.38%)	1 / 41 (2.44%)	0 / 41 (0.00%)	1 / 42 (2.38%)	1 / 42 (2.38%)	1 / 41 (2.44%)	2 / 43 (4.65%)	3 / 39 (7.69%)	2 / 38 (5.26%)	0 / 41 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	1 / 38 (2.63%)	1 / 39 (2.56%)
occurrences all number	1	1	0	1	1	1	2	4	2	0	0	1	1	1
Back Pain
subjects affected / exposed	0 / 42 (0.00%)	3 / 41 (7.32%)	1 / 41 (2.44%)	0 / 42 (0.00%)	2 / 42 (4.76%)	0 / 41 (0.00%)	0 / 43 (0.00%)	0 / 39 (0.00%)	0 / 38 (0.00%)	1 / 41 (2.44%)	1 / 39 (2.56%)	2 / 40 (5.00%)	1 / 38 (2.63%)	0 / 39 (0.00%)
occurrences all number	0	3	1	0	2	0	0	0	0	1	1	2	1	0
Infections and infestations
Gastroenteritis
subjects affected / exposed	0 / 42 (0.00%)	1 / 41 (2.44%)	1 / 41 (2.44%)	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 41 (0.00%)	0 / 43 (0.00%)	2 / 39 (5.13%)	1 / 38 (2.63%)	0 / 41 (0.00%)	0 / 39 (0.00%)	2 / 40 (5.00%)	1 / 38 (2.63%)	1 / 39 (2.56%)
occurrences all number	0	1	1	0	0	0	0	4	1	0	0	2	1	1
Influenza
subjects affected / exposed	0 / 42 (0.00%)	0 / 41 (0.00%)	1 / 41 (2.44%)	0 / 42 (0.00%)	0 / 42 (0.00%)	0 / 41 (0.00%)	0 / 43 (0.00%)	1 / 39 (2.56%)	0 / 38 (0.00%)	0 / 41 (0.00%)	0 / 39 (0.00%)	2 / 40 (5.00%)	1 / 38 (2.63%)	1 / 39 (2.56%)
occurrences all number	0	0	1	0	0	0	0	1	0	0	0	2	1	1
Nasopharyngitis
subjects affected / exposed	1 / 42 (2.38%)	6 / 41 (14.63%)	4 / 41 (9.76%)	1 / 42 (2.38%)	1 / 42 (2.38%)	2 / 41 (4.88%)	2 / 43 (4.65%)	4 / 39 (10.26%)	6 / 38 (15.79%)	1 / 41 (2.44%)	7 / 39 (17.95%)	4 / 40 (10.00%)	5 / 38 (13.16%)	6 / 39 (15.38%)
occurrences all number	1	6	4	1	1	2	2	4	8	1	7	5	11	7
Sinusitis
subjects affected / exposed	1 / 42 (2.38%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 42 (2.38%)	2 / 42 (4.76%)	0 / 41 (0.00%)	0 / 43 (0.00%)	2 / 39 (5.13%)	1 / 38 (2.63%)	1 / 41 (2.44%)	1 / 39 (2.56%)	0 / 40 (0.00%)	0 / 38 (0.00%)	0 / 39 (0.00%)
occurrences all number	1	0	0	1	2	0	0	2	1	1	1	0	0	0
Upper Respiratory Tract Infection
subjects affected / exposed	1 / 42 (2.38%)	3 / 41 (7.32%)	0 / 41 (0.00%)	1 / 42 (2.38%)	0 / 42 (0.00%)	3 / 41 (7.32%)	2 / 43 (4.65%)	4 / 39 (10.26%)	4 / 38 (10.53%)	1 / 41 (2.44%)	0 / 39 (0.00%)	3 / 40 (7.50%)	2 / 38 (5.26%)	3 / 39 (7.69%)
occurrences all number	1	3	0	2	0	3	2	5	5	1	0	4	2	3

More information

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Were there any global substantial amendments to the protocol? Yes

28 Sep 2011

The first amendment was implemented before the study was initiated, and included the following changes: addition of an exclusion criterion regarding the use of anti-TNFα agents, clarification of the reference time point for receiving treatments targeted to IL -12, IL 17A, or IL 23 in inclusion/exclusion criteria, updating of exclusion criterion regarding time frame for receiving live vaccines, removal of interactive voice response system (IVRS) as a method of collecting unblinding information, clarification of the time frame for the observation for severe allergic reactions, and other minor editorial changes.

27 Feb 2012

The second amendment included the following changes: an inclusion criterion was updated to allow entry of participants willing to receive adalimumab injections by a care provider at home, the exclusion criterion requiring participants not to have a known history of human immunodeficiency virus (HIV) was updated to require documentation of a negative HIV test prior to enrollment. In addition, text was added to clarify the exact duration of sample storage, the Sponsor’s name was changed from Centocor to Janssen Research & Development, and other minor editorial changes.

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Clinical Trial Results:
A Phase 2 Multicenter, Randomized, Placebo- and Active-Comparator-Controlled, Dose-Ranging Trial to Evaluate CNTO1959 for the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis (X-PLORE)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Participants With Cleared or Minimal (0 or 1) Physician's Global Assessment (PGA) Score at Week 16

Primary: Number of Participants With Cleared or Minimal (0 or 1) Physician's Global Assessment (PGA) Score at Week 16

Secondary: Number of Participants With 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score

Secondary: Number of Participants With 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score

Secondary: Percentage of Participants Achieving the Physician's Global Assessment (PGA) score of cleared (0) or minimal (1) at Week 16 and Week 40

Secondary: Percentage of Participants Achieving the Physician's Global Assessment (PGA) score of cleared (0) or minimal (1) at Week 16 and Week 40

Secondary: Change from baseline in Dermatology Life Quality Index (DLQI) at Week 16

Secondary: Change from baseline in Dermatology Life Quality Index (DLQI) at Week 16

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical trials

Clinical Trial Results: A Phase 2 Multicenter, Randomized, Placebo- and Active-Comparator-Controlled, Dose-Ranging Trial to Evaluate CNTO1959 for the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis (X-PLORE)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Participants With Cleared or Minimal (0 or 1) Physician's Global Assessment (PGA) Score at Week 16

Primary: Number of Participants With Cleared or Minimal (0 or 1) Physician's Global Assessment (PGA) Score at Week 16

Secondary: Number of Participants With 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score

Secondary: Number of Participants With 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score

Secondary: Percentage of Participants Achieving the Physician's Global Assessment (PGA) score of cleared (0) or minimal (1) at Week 16 and Week 40

Secondary: Percentage of Participants Achieving the Physician's Global Assessment (PGA) score of cleared (0) or minimal (1) at Week 16 and Week 40

Secondary: Change from baseline in Dermatology Life Quality Index (DLQI) at Week 16

Secondary: Change from baseline in Dermatology Life Quality Index (DLQI) at Week 16

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 2 Multicenter, Randomized, Placebo- and Active-Comparator-Controlled, Dose-Ranging Trial to Evaluate CNTO1959 for the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis (X-PLORE)