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Monoclonal Antibodies
Guselkumab for Scalp Psoriasis
Phase 4
Recruiting
Led By Raymond Cho, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 9 months
Awards & highlights
Study Summary
This trial looks at how an injection can reduce scalp psoriasis symptoms by blocking immune cells.
Who is the study for?
This trial is for individuals with moderate to severe scalp psoriasis, indicated by a PSSI score of 12 or higher. It's not suitable for those who've used systemic immunosuppressives recently, are pregnant or breastfeeding, have severe immune deficiencies, active serious infections like tuberculosis, any current cancers, or men trying to conceive.Check my eligibility
What is being tested?
The study focuses on Guselkumab and its effects on the immune cells in scalp psoriasis lesions. Specifically, it looks at how blocking IL-23 with this medication influences the condition.See study design
What are the potential side effects?
Guselkumab may cause side effects such as injection site reactions (like pain or swelling), headaches, joint pain, stomach issues and potential increased risk of infections due to its impact on the immune system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in psoriasis scalp severity index score (PSSI)
Side effects data
From 2020 Phase 4 trial • 1027 Patients • NCT035733238%
Upper respiratory tract infection
5%
Nasopharyngitis
1%
Endometrial cancer stage iv
1%
Injection site reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Guselkumab
Ixekizumab
Ixekizumab Post-Treatment Follow Up
Guselkumab Post-Treatment Follow Up
Trial Design
1Treatment groups
Experimental Treatment
Group I: Guselkumab treatmentExperimental Treatment1 Intervention
Guselkumab treatment for ~ 9 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~5990
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,545 Total Patients Enrolled
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,508 Total Patients Enrolled
Raymond Cho, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
90 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a severe immune system problem.I do not have tuberculosis or any serious infection.I have not taken any immunosuppressive drugs in the last 4 weeks.I have an active cancer that is affecting my whole body.I am a male trying to have a child.Your psoriasis on your scalp is very severe.
Research Study Groups:
This trial has the following groups:- Group 1: Guselkumab treatment
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Scalp Psoriasis Patient Testimony for trial: Trial Name: NCT05858632 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Guselkumab obtained regulatory authorization in the United States?
"Guselkumab has obtained a safety rating of 3, as this therapeutic intervention is approved and supported by Phase 4 trial data."
Answered by AI
Is there still availability for participants in this research project?
"This medical research, which was first announced on July 1st 2023 and recently updated on May 4th 2023, is urgently looking for participants according to clinicaltrials.gov."
Answered by AI
How many individuals have chosen to participate in this trial?
"Affirmative. Clinicaltrials.gov presents evidence that this clinical trial, originally posted on July 1st 2023, is actively searching for potential candidates. A total of 10 patients need to be admitted from a single medical institution."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
University of California San Francisco
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
scaring on my sclap. I would like to clear my psoriasis. I want to contribute to science development by volunteering. I'm also looking forward for the principle of beneficence hoping to address my medical condition.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How much is the pay?
PatientReceived no prior treatments
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