Guselkumab for Psoriasis Vulgaris (Plaque Psoriasis)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Psoriasis Vulgaris (Plaque Psoriasis)+2 More
Guselkumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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
  • Psoriasis Vulgaris (Plaque Psoriasis)
  • Psoriasis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

4 Primary · 17 Secondary · Reporting Duration: Up to Week 116

Baseline and Week 16
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 B: Change from Baseline in PSSI Score at Week 16
Cohort B: Change from Baseline in Scalp Surface Area (SSA) at Week 16
Cohorts A and B: Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
Cohorts A and B: Change from Baseline in PSSD Symptom Score at Week 16
Up to Week 116
Cohorts A and B: Number of Participants with Adverse Events (AEs)
Cohorts A and B: Number of Participants with Serious Adverse Events (SAEs)
Up to Week 16
Cohort A: Time to >=90% Reduction in PASI Score
Cohort B: Time to >=90% Reduction in PSSI Score
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
Cohort A: Percentage of Participants who Achieve IGA Score of Cleared (0) at Week 16
Cohort A: Percentage of Participants who Achieve PASI 100 Response at Week 16
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 PSSI 100 Response at Week 16
Cohort B: Percentage of Participants who Achieve Psoriasis Scalp Severity Index (PSSI) 90 Response at Week 16
Cohort B: Percentage of Participants who Achieve Scalp-specific Investigator Global Assessment (ss-IGA) Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16
Cohort B: Percentage of Participants who Achieve ss-IGA Score of Absence of Disease (0) at Week 16
Cohort B: Percentage of Participants with >= 4 Point Reduction (Improvement) from Baseline in the Scalp Itch NRS Score at Week 16, Among Participants with Baseline Scalp Itch >=4 at Baseline
Cohorts A and B: Percentage of Participants who Achieve a PSSD Symptom Score of 0 at Week 16, Among Randomized Participants with Baseline PSSD Symptom Score >=1

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Ixekizumab
9%Injection site reaction
8%Upper respiratory tract infection
7%Nasopharyngitis
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03573323) in the Ixekizumab ARM group. Side effects include: Injection site reaction with 9%, Upper respiratory tract infection with 8%, Nasopharyngitis with 7%.

Trial Design

2 Treatment Groups

Cohort B: Moderate-to-severe Scalp Psoriasis
1 of 2
Cohort A: Moderate-to-severe Plaque Psoriasis
1 of 2

Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: Guselkumab · Has Placebo Group · Phase 3

Cohort B: Moderate-to-severe Scalp PsoriasisExperimental Group · 2 Interventions: Placebo, Guselkumab · Intervention Types: Drug, Drug
Cohort A: Moderate-to-severe Plaque PsoriasisExperimental Group · 2 Interventions: Placebo, Guselkumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Guselkumab
2015
Completed Phase 4
~5280

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 116

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
918 Previous Clinical Trials
6,326,685 Total Patients Enrolled
4 Trials studying Psoriasis Vulgaris (Plaque Psoriasis)
574 Patients Enrolled for Psoriasis Vulgaris (Plaque Psoriasis)
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
707 Previous Clinical Trials
3,899,663 Total Patients Enrolled
4 Trials studying Psoriasis Vulgaris (Plaque Psoriasis)
574 Patients Enrolled for Psoriasis Vulgaris (Plaque Psoriasis)

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have plaque psoriasis for at least 6 months before the first administration of study drug.
You are non-white or non-caucasian.
You are a candidate for phototherapy or systemic treatment for psoriasis.
You agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: November 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Georgia100.0%
How old are they?
< 18100.0%
What site did they apply to?
Marietta Dermatology Clinical Research100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%