Deucravacitinib (BMS-986165) for Pityriasis Rubra Pilaris

NCT06444399 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 23-012923
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pityriasis Rubra Pilaris

Outcome Measures

Primary Outcomes (1)

• Change in PASI scores

  The Psoriasis Area and Severity Index (PASI) is used to assess the severity of psoriasis. The PASI score evaluates the discoloration, thickness, scaling, and coverage of psoriatic plaques on the skin. It ranges from 0 to 72, with higher scores indicating greater severity.

  Baseline, 24 weeks

Secondary Outcomes (4)

• Change in patient´s assessment of itch as measured by numeric rating scale

  Baseline, 24 weeks

• Change in the Dermatology life quality index (DLQI)

  Baseline, 24 weeks

• Change in the Skindex-16

  Baseline, 24 weeks

• Change in Investigator Global Assessment (IGA)

  Baseline, 24 weeks

Study Arms (1)

Pityriasis Rubra Pilaris

EXPERIMENTAL

Subjects will receive Deucravacitinib, twice daily for 24 weeks

Drug: Deucravacitinib

Interventions

Deucravacitinib DRUG

6 mg administered orally twice daily for 24 weeks.

Pityriasis Rubra Pilaris

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent must be obtained before any assessment is performed.
• Female and male patients ≥ 18 years of age.
• Subjects must have a diagnosis of PRP type 1, 2.
• Biopsy result consistent with PRP and not diagnostic for another disease.
• Moderate to severe disease defined as Psoriasis Area and Severity Index (PASI) ≥ 10.
• Candidates for systemic therapy.
• Inadequate response to or not suitable for topical therapy in the opinion of the investigator.
• If using any of the allowed topical treatments on the affected areas, the dose and application frequency should remain stable for 2 weeks prior to randomization and until Week 24.

You may not qualify if:

• On excluded therapies, not on a stable dose of a therapy, or incompletely washed out for a therapy (Table-1.).
• Previous use of a TYK2 inhibitor/enrollment in TYK2 inhibitor trials.
• Known hypersensitivity or other adverse reaction to Deucravacitinib (BMS-986165).
• HIV related PRP (PRP type 6).
• atypical forms of PRP, e.g. presenting with ichtyosiform dermatitis, coarse palmoplantar keratosis.
• Currently enrolled in any other clinical trial involving any investigational agent or device.
• Presence of any other skin condition that may affect the evaluations of the study disease.
• Current, severe, progressive or uncontrolled diseases that render the patient unsuitable for the trial, including any medical or psychiatric condition that, in the Investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
• Ongoing use of ANY treatment prohibited by the protocol (Tables 1 \& 2).
• Pregnant or nursing (lactating) women (pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test).
• Women of childbearing potential unless they are using basic methods of contraception which includes:
• Total abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;
• Female sterilization (have had surgical bilateral oophorectomy \[with or without hysterectomy\], total hysterectomy or tubal ligation at least six weeks before taking study; treatment). In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment;
• Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that patient;
• Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps);

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

MeSH Terms

Conditions

Pityriasis Rubra Pilaris

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Pityriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Aaron Mangold, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron Mangold, MD

CONTACT

(480) 301-8000; mangold.aaron@mayo.edu

Hannah Samuel Gnanadas

CONTACT

480-301-6232; samuelgnanadas.hannah@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 5, 2024
• Study Start: July 29, 2024
• Primary Completion: September 2, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)