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Monoclonal Antibodies

Guselkumab for Psoriasis (VISIBLE Trial)

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a diagnosis of plaque psoriasis (with or without psoriatic arthritis [PsA]) for at least 6 months before the first administration of study drug

Be a candidate for phototherapy or systemic treatment for psoriasis

Must not have

Has a nonplaque form of psoriasis (example: erythrodermic, guttate, or pustular)

Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 116

Awards & highlights

Pivotal Trial

Summary

This trial will test whether the drug guselkumab is better than placebo at improving the signs and symptoms of psoriasis in people with dark skin.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include allergic reactions to ingredients in Guselkumab, infections like pneumonia or sepsis due to immune system changes caused by the drug, and possibly other disturbances across various body systems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with plaque psoriasis for at least 6 months.

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I am eligible for light therapy or medication for my psoriasis.

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I am eligible for light therapy or medication for my psoriasis.

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I have severe psoriasis affecting more than 10% of my body or 30% of my scalp.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My psoriasis is not the common plaque type.

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

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I have had a serious infection or was treated with IV antibiotics in the last 2 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 116

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 116

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 116 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Cohort A: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16

Cohort B: Percentage of Participants who Achieve Psoriasis Scalp Severity Index (PSSI) 90 Response at Week 16

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Secondary study objectives

Cohort A: Change from Baseline in Body Surface Area (BSA) at Week 16

Cohort A: Change from Baseline in PASI Score at Week 16

Cohort A: Percentage of Participants who Achieve >= 4-point Reduction (Improvement) from Baseline in the Psoriasis Symptom and Sign Diary (PSSD) Itch Score at Week 16, Among Participants with Baseline PSSD Itch >= 4 at Baseline

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