A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis

Conditions

• Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Guselkumab 100 mg — DRUG
  100 mg by subcutaneous injection at Weeks 0, 4 and q8w thereafter through Week 252 (Group 1). 100 mg by subcutaneous injection at Weeks 16, 20 and q8w thereafter through Week 252 (Group II). 100 mg by subcutaneous injection at Week 52 and q8w thereafter through Week 252 (Group III).
• Placebo for guselkumab — DRUG
  Subcutaneous injections to maintain the blind.
• Adalimumab — DRUG
  80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 47.
• Placebo for adalimumab — DRUG
  Subcutaneous injections to maintain the blind.

Study Details

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.

Key Dates

Start date

Nov 26, 2014

Status verified

Jul 2021

Primary completion

Sep 29, 2015

Completion

Jun 17, 2020

Study Design

Enrollment

837 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group I
  Participants received Guselkumab 100 milligram (mg) at Weeks 0, 4, and 12 and every 8 weeks (q8w) thereafter through Week 252, placebo for guselkumab at Week 16, and placebo for adalimumab (two 0.8 milliliter \[mL\] injections) at Week 0 followed by one 0.8 mL injection at Weeks 1, 3, and 5, and every 2 weeks (q2w) thereafter through Week 47.
• Placebo Comparator: Group II
  Participants received Placebo for guselkumab at Weeks 0, 4, and 12, and placebo for adalimumab (two 0.8 mL injections) at Week 0, followed by one 0.8 mL injection at Weeks 1, 3, and 5, and q2w through Week 15. At Week 16, placebo participants will cross over to receive guselkumab 100 mg at Weeks 16 and 20 and q8w thereafter through Week 252, as well as placebo for adalimumab at Weeks 17, 19, 21, and 23, and q2w thereafter through Week 47.
• Active Comparator: Group III
  Participants received Adalimumab 80 mg at Week 0 (two 40 mg \[0.8 mL\] injections) and 40 mg at Weeks 1, 3, 5, and q2w thereafter through Week 47, placebo for guselkumab at Weeks 0, 4, 12, 16, and 20, and q8w thereafter through Week 44 and guselkumab 100 mg at Weeks 52, 60, and q8w thereafter through Week 252.

Primary Outcome Measure

Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16 [ Time Frame: Week 16 ]

Locations (26)

Find similar trials in Los Angeles, CA

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