Actively Recruiting
Deucravacitinib (BMS-986165) for Pityriasis Rubra Pilaris
Led by Mayo Clinic · Updated on 2026-02-10
12
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and effectiveness of Deucravacitinib (BMS-986165) in Pityriasis Rubra Pilaris as assessed by the change in Investigator Global Assessment (IGA), PASI- 50, 75, 90, DLQI, NRS itch, and Skindex-16 at week 24. To predict responses through the identification of unique biomarkers of PRP utilizing single-cell RNA sequencing.
CONDITIONS
Official Title
Deucravacitinib (BMS-986165) for Pityriasis Rubra Pilaris
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before any assessments
- Male or female patients aged 18 years or older
- Diagnosis of Pityriasis Rubra Pilaris type 1 or 2
- Biopsy confirming PRP and excluding other diseases
- Moderate to severe disease with PASI score of 10 or higher
- Candidates for systemic therapy
- Inadequate response to or unsuitable for topical therapy as judged by the investigator
- Stable dose and application frequency of allowed topical treatments for at least 2 weeks before randomization and until week 24
You will not qualify if you...
- Use of excluded therapies, unstable doses, or incomplete washout as defined in protocol
- Previous use of TYK2 inhibitors or participation in TYK2 inhibitor trials
- Known allergy or adverse reaction to Deucravacitinib
- HIV-related PRP (type 6) or atypical PRP forms
- Participation in another clinical trial with investigational agents or devices
- Other skin conditions affecting study evaluations
- Severe, uncontrolled medical or psychiatric conditions preventing study adherence
- Use of prohibited treatments per protocol
- Pregnant or nursing women
- Women of childbearing potential not using effective contraception
- Significant immunocompromising conditions or unacceptable risk for immunomodulatory therapy
- Moderate to severe kidney impairment (eGFR < 60 mL/min/1.73m2)
- Active systemic infections within 2 weeks prior to randomization (except common colds)
- Recent major surgery or planned surgery posing unacceptable risk
- Recent serious cardiovascular events or history of recurrent venous thromboembolism
- History or signs of lymphoproliferative or malignant disease within 5 years
- Recent or complicated herpes zoster infection
- Abnormal liver function tests or blood counts outside protocol limits
- Positive tests for hepatitis B or C infection without appropriate treatment or monitoring
- Evidence or history of active or latent tuberculosis without proper treatment
- Exposure to live vaccines within 12 weeks prior to randomization or expected during study
- Recent blood donation exceeding one unit or planned donation during study
- History of substance abuse within 2 years or current illicit drug use
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
Research Team
A
Aaron Mangold, MD
CONTACT
H
Hannah Samuel Gnanadas
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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