Deucravacitinib (BMS-986165) in the Treatment of Pityriasis Rubra Pilaris

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
United States
Arizona
Mayo Clinic in Arizona
RECRUITING
Scottsdale
Contact Information
Primary
Aaron Mangold, MD
mangold.aaron@mayo.edu
(480) 301-8000
Backup
Hannah Samuel Gnanadas
samuelgnanadas.hannah@mayo.edu
480-301-6232
Time Frame
Start Date: 2024-07-29
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 12
Treatments
Experimental: Pityriasis Rubra Pilaris
Subjects will receive Deucravacitinib, twice daily for 24 weeks
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov

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