Guselkumab for Psoriasis
(VISIBLE Trial)

Recruiting in Palo Alto (17 mi)

+103 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for non-white individuals with moderate-to-severe plaque or scalp psoriasis. Participants must have a body surface area involvement of at least 10% or a scalp surface area of at least 30%, among other severity criteria. They should not have received certain psoriasis treatments recently and cannot get live vaccines during the study.

Inclusion Criteria

I agree not to get a BCG vaccine during and for 12 weeks after the study.

I agree not to get any live vaccines during or up to 12 weeks after the study.

You are not white or of Caucasian descent.

+13 more

Exclusion Criteria

I have severe ongoing health issues affecting my organs or mental health.

My psoriasis is not the common plaque type.

You are allergic or have bad reactions to guselkumab or its ingredients.

+2 more

Participant Groups

The study tests the effectiveness of Guselkumab, an injectable medication, compared to a placebo in improving symptoms of psoriasis in skin of color participants. The goal is to see if there's significant improvement in those receiving Guselkumab.

2Treatment groups

Experimental Treatment

Group I: Cohort B: Moderate-to-severe Scalp PsoriasisExperimental Treatment2 Interventions

Participants will receive either guselkumab SC or placebo SC. Placebo participants will then crossover to receive guselkumab SC.

Group II: Cohort A: Moderate-to-severe Plaque PsoriasisExperimental Treatment2 Interventions

Participants will receive either guselkumab subcutaneously (SC) or placebo SC. Placebo participants will then crossover to receive guselkumab SC.

Guselkumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tremfya for: