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Monoclonal Antibodies

guselkumab for Pityriasis Rubra Pilaris

Phase 2
Waitlist Available
Led By Teri Greiling, MD, PhD
Research Sponsored by Oregon Health and Science University
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 36 weeks
Awards & highlights

Study Summary

This trial will test the safety and efficacy of guselkumab for the treatment of 15 patients with PRP. Participants will be required to travel to Portland, OR for the first visit, week-4 visit, and week-24 visit, but 3 visits in between these times and one follow up visit may be performed by secure videoconferencing.

Eligible Conditions
  • Pityriasis Rubra Pilaris

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change from baseline PASI at week-24 after treatment with guselkumab.
Secondary outcome measures
Proportion of subjects achieving a 4-point improvement in quality of life measured by the Dermatology Life Quality Index (DLQI) at week-24.
Proportion of subjects with sustained remission at week-36, 16 weeks after the last guselkumab dose, as measured by the mean change in PASI from week-24 to week-36.

Trial Design

1Treatment groups
Experimental Treatment
Group I: guselkumab treatmentExperimental Treatment1 Intervention
Treatment with guselkumab for 20 weeks

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
973 Previous Clinical Trials
6,846,015 Total Patients Enrolled
1 Trials studying Pityriasis Rubra Pilaris
12 Patients Enrolled for Pityriasis Rubra Pilaris
Teri Greiling, MD, PhDPrincipal Investigator - Oregon Health and Science University
OHSU Healthcare
University Of Washington School Of Medicine (Medical School)
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Pityriasis Rubra Pilaris
12 Patients Enrolled for Pityriasis Rubra Pilaris

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the guselkumab success rate in terms of FDA approval?

"While there is some data supporting guselkumab's safety, it only received a score of 2 because Phase 2 trials have yet to establish efficacy."

Answered by AI

Does this experiment explore uncharted territory?

"There are a total of 21 ongoing guselkumab trials in 282 cities and 57 different countries. The first such trial was sponsored by Janssen Research & Development, LLC in 2018. This initial study involved 1406 patients and completed its Phase 2 & 3 drug approval stage. In the years since 2018, an additional 30 trials have been conducted."

Answered by AI

Will this clinical trial be recruiting new patients soon?

"Pityriasis rubra pilaris patients are not being recruited for this clinical trial at the moment. This study was originally posted on October 3, 2019 and was most recently updated on April 8, 2020. There are 1 other active clinical trials recruiting pityriasis rubra pilaris patients and 21 studies searching for guselkumab participants."

Answered by AI

How many people are currently signed up to help test this new medication?

"This study is not recruiting patients at the moment. It was originally posted on October 3rd, 2019 and updated most recently on April 8th, 2022. If you are looking for other trials, there are 1 trial enrolling patients with pityriasis rubra pilaris and 21 guselkumab trials that are actively searching for patients."

Answered by AI

Does this research include people aged 40 or above?

"From the eligibility requirements, it is clear that this trial is for patients aged 18-99. If an applicant is under 18 or over 65, there are 1 and 21 other studies respectively that they may be qualified for."

Answered by AI

What other data is available on guselkumab's efficacy?

"There are a total of 21 ongoing clinical trials for guselkumab, 7 of which are in Phase 3. The largest concentration of these research studies is in Milan and Kansas, but there are 2,682 locations worldwide where patients can participate."

Answered by AI

Are there any prerequisites for participants in this trial?

"The ideal candidate for this clinical trial is a female aged 18-99 with pityriasis rubra pilaris that covers at least 10% of their body. The patient must also be unresponsive to phototherapy and/or systemic therapy. If the patient is sexually active, they must agree to use birth control or remain abstinent throughout the study and for 12 weeks after the final dose of guselkumab. Male patients who meet the other criteria are also eligible for this trial."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Oregon Health and Science University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP)
Teri Greiling 2019. "Guselkumab in the Treatment of Pityriasis Rubra Pilaris (PRP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03975153.
~3 spots leftby Apr 2025
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