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Monoclonal Antibodies

Guselkumab for Psoriasis(VISIBLE Trial)

Skin Care Physicians of Georgia, Macon, GA
Targeting 2 different conditionsGuselkumab +1 morePhase 3Waitlist AvailableResearch Sponsored by Janssen Research & Development, LLC

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.

Eligible Conditions
  • Plaque Psoriasis
  • Scalp Psoriasis

VISIBLE Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You are scheduled to receive light therapy or medication for psoriasis treatment.
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You cannot receive any live virus or bacteria vaccines during the study or for 12 weeks after the study ends.
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You have been diagnosed with plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before starting the study.

VISIBLE Trial Timeline

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

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 more
Secondary 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 more

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Guselkumab Post-Treatment Follow Up
Ixekizumab
Guselkumab
Ixekizumab Post-Treatment Follow Up

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~5720
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
963 Previous Clinical Trials
6,378,482 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
739 Previous Clinical Trials
3,958,266 Total Patients Enrolled

Media Library

Guselkumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05272150 — Phase 3
Scalp Psoriasis Research Study Groups: Cohort A: Moderate-to-severe Plaque Psoriasis, Cohort B: Moderate-to-severe Scalp Psoriasis
Scalp Psoriasis Clinical Trial 2023: Guselkumab Highlights & Side Effects. Trial Name: NCT05272150 — Phase 3
Guselkumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05272150 — Phase 3

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, 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
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
Recent research and studies
clinicaltrials.govStudy
Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis
2022. "Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05272150.
All > Paid Studies Georgia > Maryland
~116 spots leftby Jul 2025
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