Overview

This trial is active, not recruiting.

Condition psoriasis
Treatments guselkumab 100 mg, placebo for guselkumab, adalimumab, placebo for adalimumab
Phase phase 3
Target TNF-alpha
Sponsor Janssen Research & Development, LLC
Start date November 2014
End date October 2015
Trial size 992 participants
Trial identifier NCT02207244, 2014-000720-18, CNTO1959PSO3002, CR105048

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants will receive guselkumab 100 milligram (mg) at Weeks 0, 4, 12 and 20, starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 148 depending upon randomized treatment group and PASI response. Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending upon randomized treatment group and PASI response. Placebo for adalimumab [two 0.8 milliliter (mL) injections] at Week 0 followed by one 0.8 mL injection at Weeks 1, 3, 5, and every 2 week (q2w) through Week 23 to maintain the blind.
guselkumab 100 mg CNTO 1959
100 mg by subcutaneous injection at Weeks 0, 4, 12, and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 148 depending upon randomized treatment group and PASI response (Group I). 100 mg by subcutaneous injection at Weeks 16 and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 148 depending upon PASI response (Group II). Starting at Week 28, participants will receive guselkumab 100 mg through Week 148 depending upon PASI response (Group III).
placebo for guselkumab
Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 (Group I), at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response (Group II), at weeks 0, 4, 12, 16, and 20, starting at week 28 through week 72 depending upon PASI response (Group III).
placebo for adalimumab
Placebo for adalimumab [two 0.8 milliliter (mL) injections] at week 0 followed by one 0.8 mL injection at weeks 1, 3, 5, and every 2 week (q2w) through Week 23 (Group I and II).
(Placebo Comparator)
Participants will receive placebo for guselkumab at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response. Placebo for adalimumab (two 8 mL injections) at week 0, followed by one 0.8 mL injection at weeks 1, 3, and 5, and q2w through week 23. At week 16, placebo paticipants will cross over to receive guselkumab 100 mg at Weeks 16 and 20, starting at week 28, participants will continue to receive guselkumab 100 mg through week 148 depending upon PASI response.
guselkumab 100 mg CNTO 1959
100 mg by subcutaneous injection at Weeks 0, 4, 12, and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 148 depending upon randomized treatment group and PASI response (Group I). 100 mg by subcutaneous injection at Weeks 16 and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 148 depending upon PASI response (Group II). Starting at Week 28, participants will receive guselkumab 100 mg through Week 148 depending upon PASI response (Group III).
placebo for guselkumab
Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 (Group I), at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response (Group II), at weeks 0, 4, 12, 16, and 20, starting at week 28 through week 72 depending upon PASI response (Group III).
placebo for adalimumab
Placebo for adalimumab [two 0.8 milliliter (mL) injections] at week 0 followed by one 0.8 mL injection at weeks 1, 3, 5, and every 2 week (q2w) through Week 23 (Group I and II).
(Active Comparator)
Participants will receive adalimumab 80 mg (two 40 mg [0.8 mL] injections) at Week 0 followed by adalimumab 40 mg at weeks 1, 3, 5, and q2w through week 23 and placebo for guselkumab at weeks 0, 4, 12, 16, and 20, starting at week 28 through week 72 depending upon PASI response. Guselkumab 100 mg starting at week 28 through week 148 depending upon PASI response.
guselkumab 100 mg CNTO 1959
100 mg by subcutaneous injection at Weeks 0, 4, 12, and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 148 depending upon randomized treatment group and PASI response (Group I). 100 mg by subcutaneous injection at Weeks 16 and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 148 depending upon PASI response (Group II). Starting at Week 28, participants will receive guselkumab 100 mg through Week 148 depending upon PASI response (Group III).
placebo for guselkumab
Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 (Group I), at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response (Group II), at weeks 0, 4, 12, 16, and 20, starting at week 28 through week 72 depending upon PASI response (Group III).
adalimumab HUMIRA®
80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 23.

Primary Outcomes

Measure
Percentage of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 comparing the guselkumab group and the placebo group
time frame: Week 16
Percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response comparing the guselkumab group and the placebo group
time frame: Week 16

Secondary Outcomes

Measure
Percentage of participants who achieve an IGA Score 0, comparing the guselkumab group and the adalimumab group
time frame: Week 24
Percentage of participants who achieve an IGA Score 0 or 1, comparing the guselkumab group and the adalimumab group
time frame: Week 24
Percentage of participants who achieve a PASI 90 Response, comparing the guselkumab group and the adalimumab group
time frame: Week 24
The time to loss of PASI 90 response through Week 48, comparing participants randomized to placebo and participants randomized to continue guselkumab 100 mg every 8 weeks (q8w) at Week 28
time frame: Week 28 through Week 48
The change from Baseline in Dermatology Life Quality Index (DLQI) score, comparing the guselkumab group and the placebo group
time frame: Week 16
The percentage of participants who achieve an IGA score of 0 or 1, comparing the guselkumab group and the adalimumab group
time frame: Week 16
The percentage of participants who achieve a PASI 90 response, comparing the guselkumab group and the adalimumab group
time frame: Week 16
The percentage of participants who achieve a PASI 75 response, comparing the guselkumab group and the adalimumab group
time frame: Week 16
The percentage of participants who achieve a Scalp Specific (ss) IGA score of 0 or 1 and have at least a 2-grade improvement from Baseline, comparing the guselkumab group and the adalimumab group
time frame: Week 16
The change from Baseline in Psoriasis Symptom and Sign Diary (PSSD) symptom score, comparing the guselkumab group and the placebo group
time frame: Week 16
The percentage of participants who achieve a PSSD symptom score of 0, comparing the guselkumab group and adalimumab group
time frame: Week 24
The percentage of participants who achieve an IGA score of 0 and the percentage of participants achieving an IGA score of ≤2
time frame: Week 16
The percentage of participants who achieve a PASI 100 response, PASI 75 response, and a PASI 50 response
time frame: Week 16
The percent improvement from Baseline in PASI response
time frame: Week 16
The percentage of participants who achieve a DLQI score=0 or 1
time frame: Week 16
The percentage of participants with a reduction of 5 or more points in DLQI score
time frame: Week 16
The percent improvement from Baseline in Nail Psoriasis Area and Severity Index (NAPSI)
time frame: Week 16
The percentage of participants who achieve an Fingernail Physician's Global Assessment (f-PGA) score of 0 or 1 and have at least 1-grade improvement from Baseline
time frame: Week 16
The percentage of participants who achieve a PSSD symptom score of 0
time frame: Week 16
The percentage of participants who achieve a PSSD sign score of 0
time frame: Week 16
The change from Baseline in individual scale score of PSSD components
time frame: Week 16
The percentage of participants who achieve a PSSD individual scale score of 0
time frame: Week 16
The percentage of participants who achieve an hf-PGA score of 0 or 1 and a reduction of at least 2 grades on the hf-PGA scale from Baseline
time frame: Week 16
Change from Baseline in the physical and mental component summary scores of the SF-36
time frame: Week 16
The change from Baseline in Hospital Anxiety and Depression Scale (HADS)
time frame: Week 16
The change from Baseline in Work Limitations Questionnaire (WLQ)
time frame: Week 16
The percentage of participants who achieve a PASI 75 response and a PASI 100 response
time frame: Week 24
The percentage of participants who achieve an ss-IGA score of 0 or 1 and at least a 2-grade improvement from Baseline
time frame: Week 24
The percent improvement from Baseline in NAPSI
time frame: Week 24
The percentage of participants who achieve an f-PGA score of 0 or 1 and have at least a 1-grade improvement from Baseline
time frame: Week 24
The percentage of participants who achieve an hf-PGA score of 0 or 1 and at least a 2-grade improvement from Baseline
time frame: Week 24
The percentage of participants who achieve a DLQI score of 0 or 1
time frame: Week 24
The change from Baseline in the PSSD symptom score
time frame: Week 24
The percentage of participants who achieve PSSD sign score=0
time frame: Week 24
The change from Baseline in individual scale score of PSSD components
time frame: Week 24
The percentage of participants who achieve PSSD individual scale score of 0
time frame: Week 24
The percentage of participants who achieve an IGA score of 0 or 1
time frame: Week 48
The percentage of participants who achieve a PASI 90 response
time frame: Week 48
The percentage of participants who achieve a PASI 90 response
time frame: Week 76

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent - Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline - Have an Investigator's Global Assessment (IGA) score >=3 at Screening and at Baseline - Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline - Must be a candidate for either systemic therapy or phototherapy for psoriasis Exclusion Criteria: - Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) - Participants who have ever received guselkumab or adalimumab - History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances - Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments - Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug

Additional Information

Official title A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis With Randomized Withdrawal and Retreatment
Description This is a randomized (assignment of study drug by chance), double-blind (neither the participant or study staff will know the identity of study drugs), placebo- (inactive substance identical in appearance to study drug) and active-comparator-controlled (use of an approved drug to compare with study drug) study of guselkumab. The active comparator study drug is adalimumab, an approved drug for the treatment of moderate to severe plaque psoriasis. Participants who satisfy all inclusion and exclusion criteria will be randomly assigned in a 2:1:1 ratio to one of three treatment groups (arms): Group I (guselkumab 100 mg dose regimen), Group II (placebo then crossover to guselkumab at Week 16), or Group III (adalimumab at standard psoriasis dosing). From Week 28 up to Week 76, treatment for all participants will be based on their level of response. All participants will receive guselkumab every 8 weeks from Week 76 through Week 148 (open label treatment period). The end of the study is defined as the time the last participant completes the Week 160 visit. Participants will primarily be assessed for Investigator's Global Assessment (IGA) Score of 0 or 1 and Psoriasis Area and Severity Index (PASI) 90 Response at Week 16. The total duration of the study will be approximately 164 weeks (includes a 4-week screening period). Participants will be monitored for safety throughout the study.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Janssen Research & Development, LLC.