Deucravacitinib (BMS-986165) for Pityriasis Rubra Pilaris

Completed · Phase 2

Conditions studied: Pityriasis Rubra Pilaris

In brief

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.

Key facts

Study ID

NCT06444399

Run by

Mayo Clinic

People needed

7

Starts

2024-07-29

Expected to finish

2026-05-01

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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);
• Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS). In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
• In case local regulations deviate from the contraception methods listed above, local regulations apply and will be described in the informed consent form (ICF).
• Note: Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks prior to enrollment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of childbearing potential.
• Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the investigator, significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
• Moderate-to-severe renal impairment including patients with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m\^2.
• Active systemic infections during the 2 weeks prior to randomization (common cold viruses excluded) or any infection that reoccurs on a regular basis.
• Current severe progressive or uncontrolled disease which the investigator renders the subject unsuitable for the trial or puts the subject at increased risk.
• Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study that, in the opinion of the investigator would pose an unacceptable risk to the patient.
• Have experienced any of the following within 12 weeks of screening: VTE (DVT/pulmonary embolism [PE]), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure.
• Have a history of recurrent (≥ 2) VTE (DVT/PE).

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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