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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 116
Awards & highlights
VISIBLE 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.Check my eligibility
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.See study design
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.
VISIBLE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with plaque psoriasis for at least 6 months.
Select...
I am eligible for light therapy or medication for my psoriasis.
Select...
I am eligible for light therapy or medication for my psoriasis.
Select...
I have severe psoriasis affecting more than 10% of my body or 30% of my scalp.
VISIBLE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 116
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 116
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
+1 moreSecondary outcome measures
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
+14 moreSide effects data
From 2020 Phase 4 trial • 1027 Patients • NCT035733239%
Injection site reaction
8%
Upper respiratory tract infection
7%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab
Guselkumab
Ixekizumab Post-Treatment Follow Up
Guselkumab Post-Treatment Follow Up
VISIBLE Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~5990
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,095 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,692 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have severe ongoing health issues affecting my organs or mental health.You are not white or of Caucasian descent.You have a large area of your body or scalp affected by psoriasis, with specific measurements and severity ratings.I agree not to get any live vaccines during and up to 12 weeks after the study.I have been diagnosed with plaque psoriasis for at least 6 months.You do not identify as white or Caucasian.I have been diagnosed with plaque psoriasis for at least 6 months.My psoriasis is not the common plaque type.I am eligible for light therapy or medication for my psoriasis.You do not identify as white or Caucasian.You are allergic or have bad reactions to guselkumab or its ingredients.I have had a serious infection or was treated with IV antibiotics in the last 2 months.I have been diagnosed with plaque psoriasis for at least 6 months.I have taken ustekinumab, ixekizumab, secukinumab, or brodalumab in the last 12 weeks.I am eligible for light therapy or medication for my psoriasis.I am eligible for light therapy or medication for my psoriasis.I agree not to get any live vaccines during or 12 weeks after the study.I agree not to get a BCG vaccine during and for 12 weeks after the study.I have severe psoriasis affecting more than 10% of my body or 30% of my scalp.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: Moderate-to-severe Plaque Psoriasis
- Group 2: Cohort B: Moderate-to-severe Scalp Psoriasis
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there different hospitals or research facilities testing this in different states?
"Patients are being accepted by Dr. Lorne E. Albrecht in Surrey, British Columbia, Cahaba Research Inc in Birmingham, Alabama and Tory P. Sullivan, M.D., PA in North Miami Beach, Massachusetts as well as at 100 other medical facilities"
Answered by AI
What is the status of Guselkumab in regards to government regulation?
"There is some evidence to support Guselkumab's efficacy, as this is a Phase 3 trial. Furthermore, the safety of Guselkumab has been supported by multiple rounds of data collection, so it received a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
Texas
Florida
How old are they?
< 18
What site did they apply to?
Marietta Dermatology Clinical Research
Central Sooner Research
Suzanne Bruce and Associates - The Center for Skin Research
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
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