Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis

Conditions

• Plaque Psoriasis
• Scalp Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Guselkumab — DRUG
  Participants will receive guselkumab as subcutaneous injection.
• Placebo — DRUG
  Participants will receive placebo as subcutaneous injection.

Study Details

The purpose of this study is to evaluate the efficacy of guselkumab treatment versus placebo in skin of color participants with predominant moderate-to-severe body psoriasis or predominant moderate-to-severe scalp psoriasis by assessing improvements in the signs and symptoms of psoriasis.

Key Dates

Start date

Jul 13, 2022

Status verified

Sep 2025

Primary completion

May 30, 2025

Completion

May 30, 2025

Study Design

Enrollment

213 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A: Moderate-to-severe Plaque Psoriasis
  Participants will receive either guselkumab subcutaneously (SC) or placebo SC. Placebo participants will then crossover to receive guselkumab SC.
• Experimental: Cohort B: Moderate-to-severe Scalp Psoriasis
  Participants will receive either guselkumab SC or placebo SC. Placebo participants will then crossover to receive guselkumab SC.

Primary Outcome Measure

Cohort A: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 [ Time Frame: Week 16 ]

Locations (79)

Related coverage on Hipa.ai

• Guselkumab Phase 3 Psoriasis Trial in Skin of Color Completes Primary Data
  Guselkumab · May 30, 2025 · ClinicalTrials.gov

Find similar trials in Birmingham, AL

Related Studies

• Triamcinolone With Vitamin D Synergistic Efficacy in Psoriasis
  EARLY_PHASE1 · Recruiting · Wright State University · Fairborn, Ohio
• Understanding Participation Habits Among Plaque Psoriasis Patients
  Not Yet Recruiting · Power Life Sciences Inc. · San Francisco, California
• A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
  PHASE3 · Recruiting · Bristol-Myers Squibb · Birmingham, Alabama
• A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ASC50 Tables in Healthy Participants and Participants With Plaque Psoriasis
  PHASE1 · Recruiting · Ascletis Pharma (China) Co., Limited · Miami, Florida