A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

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).
    

Detailed 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 252 with a final safety follow-up visit at
      Week 264 (open label treatment period). The end of the study is defined as the time the last
      participant completes the Week 264 visit. The total duration of the study will be
      approximately 268 weeks (includes a 4-week screening period). Participants will be monitored
      for safety throughout the study.
    

Intervention name(s): Guselkumab 100 mg; Placebo for guselkumab; Adalimumab; Placebo for adalimumab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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 72 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 72 depending upon PASI response (Group II). Starting at Week 28, participants will receive guselkumab 100 mg through Week 72 depending upon PASI response (Group III). All participants will receive guselkumab q8w starting at Week 76 through Week 252.; Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending on randomized treatment group and PASI response (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).; 80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 23.; 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).
Other intervention name(s): CNTO 1959; HUMIRA®
Intervention MeSH terms: Adalimumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis; Plaque-type psoriasis; Guselkumab; Adalimumab; CNTO 1959; Monoclonal antibody