Actively Recruiting
Deucravacitinib (BMS-986165) in the Treatment of Pityriasis Rubra Pilaris
Led by Mayo Clinic · Updated on 2026-02-10
12
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Deucravacitinib (BMS-986165) for treating Pityriasis Rubra Pilaris (PRP), a skin condition, in this Phase 2 study. The study also aims to identify unique biomarkers of PRP using single-cell RNA sequencing to predict patient responses to treatment. The main measures of effectiveness include changes in Investigator Global Assessment (IGA), Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), Numeric Rating Scale (NRS) for itch, and Skindex-16 at 24 weeks. Participants will receive Deucravacitinib orally at a dose of 6 mg twice daily for 24 weeks. The treatment is given continuously during this period with no placebo or comparison group described. The study focuses on patients with moderate to severe PRP who have not responded adequately to topical therapies and are candidates for systemic treatment. Throughout the study, participants will undergo evaluations of their skin condition and quality of life using various scales and questionnaires at baseline and at 24 weeks. Safety and treatment effects will be monitored, including changes in PASI scores. The total duration for each participant is 24 weeks of treatment with assessments aimed at understanding treatment impact and identifying biomarkers related to response.
CONDITIONS
Brief Title
Deucravacitinib (BMS-986165) for Pityriasis Rubra Pilaris
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent must be obtained before any assessment is performed.
- Female and male patients 18 years of age or older.
- Diagnosis of Pityriasis Rubra Pilaris (PRP) type 1 or 2.
- Biopsy result consistent with PRP and not diagnostic for another disease.
- Moderate to severe disease defined by Psoriasis Area and Severity Index (PASI) of 10 or higher.
- Candidates for systemic therapy.
- Inadequate response to or not suitable for topical therapy as judged by the investigator.
- Stable dose and application frequency of any 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 of therapies as defined in study tables.
- Previous use of TYK2 inhibitors or participation in TYK2 inhibitor trials.
- Known allergy or adverse reaction to Deucravacitinib.
- HIV-related PRP (type 6).
- Atypical forms of PRP such as ichthyosiform dermatitis or coarse palmoplantar keratosis.
- Current participation in another clinical trial with investigational agents or devices.
- Presence of other skin conditions that may affect study evaluations.
- Severe, progressive, or uncontrolled diseases or medical/psychiatric conditions precluding study adherence.
- Use of any protocol-prohibited treatments.
- Pregnant or nursing women.
- Women of childbearing potential not using approved contraception methods.
- Significant immunocompromising conditions or unacceptable risk for immunomodulatory therapy.
- Moderate-to-severe renal impairment (eGFR < 60 mL/min/1.73m2).
- Active systemic infections within 2 weeks before randomization (excluding common cold).
- Recent major surgery or planned major surgery posing unacceptable risk.
- Recent serious cardiovascular events or history of recurrent venous thromboembolism.
- History or signs of lymphoproliferative or malignant diseases within 5 years.
- Recent symptomatic or complicated herpes zoster infection.
- Abnormal liver function tests or blood cell counts outside defined limits.
- Positive tests for hepatitis B or C infections unless appropriately treated.
- Evidence of HIV infection.
- Household contact with active tuberculosis without proper prophylaxis.
- Evidence of active or inadequately treated latent tuberculosis.
- Recent or planned live vaccine administration (except herpes zoster vaccine).
- Recent blood donation exceeding one unit or planned donation during the study.
- History of substance abuse within 2 years prior to screening or expected use during the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive Deucravacitinib, taken orally twice daily for 24 weeks.
Visits scheduled at baseline and periodically during treatment up to 24 weeks
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
Research Team
A
Aaron Mangold, MD
H
Hannah Samuel Gnanadas
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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