Pityriasis Rubra PilarisPhase 2NCT06444399
Deucravacitinib (BMS-986165) for Pityriasis Rubra Pilaris
A Phase 2 study testing Deucravacitinib in people with Pityriasis Rubra Pilaris, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pityriasis Rubra Pilaris
- What is being tested?
- Deucravacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2024to 1 May 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
- Have a history of lymphoproliferative disease; have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for < 5 years prior to randomization.
- Have had symptomatic herpes zoster infection within 12 weeks prior to randomization.
- Have a history of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement).
- ALT or AST > 2 x upper limits of normal (ULN); alkaline phosphatase (ALP) ≥ 2 x ULN; total bilirubin ≥ 1.5 x ULN; hemoglobin < 10 g/dL (100.0 g/L); total white blood cell count < 3000 cells/μL (< 3.00 x 10^3/μL or < 3.00 billion/L); neutropenia (absolute neutrophil count [ANC] < 1500 cells/μL) (< 1.50 x 10^3/μL or < 1.50 billion/L); lymphopenia (lymphocyte count < 1000 cells/μL) (< 1.00 x 10^3/μL or < 1.00 bilion/L); thrombocytopenia (platelets < 100,000 cells/μL) (< 100 x 10^3/μL or < 100 billion/L).
- Have a positive test for hepatitis B virus (HBV) defined as:
- Positive for hepatitis B surface antigen (HBsAg); or
- Positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) Note: Patients who are HBcAb-positive and HBV DNA-negative may be enrolled in the study but will require additional HBV DNA monitoring during the study.
- Have hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV ribonucleic acid [RNA]-positive). Note: Patients who have documented anti-HCV treatment for a past HCV infection AND are HCV RNA-negative may be enrolled in the study.
- Have evidence of HIV infection and/or positive HIV antibodies.
- Have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB.
- Have evidence of active TB or latent TB.
- Have evidence of active TB, defined in this study as the following:
- Positive purified protein derivative (PPD) test (≥ 5 mm induration between approximately 2 and 3 days after application, regardless of vaccination history), medical history, clinical features, and abnormal chest x-ray at screening;
- QuantiFERON®-TB Gold test or T-SPOT®.TB test (as available and if compliant with local TB guidelines) may be used instead of the PPD test. Patients are excluded from the study if the test is not negative and there is clinical evidence of active TB. Exception: patients with a history of active TB who have documented evidence of appropriate treatment, have no history of re-exposure since their treatment was completed, have no clinical features of active TB, and have a screening chest x-ray with no evidence of active TB may be enrolled if other entry criteria met. Such patients would not be required to undergo the protocol-specific TB testing for PPD, QuantiFERON®-TB Gold test, or T-SPOT®.TB test but must have a chest x-ray at screening (i.e., chest imaging performed within the past 6 months will not be accepted).
- Have evidence of untreated/inadequately or inappropriately treated latent TB, defined in this study as the following:
- Positive PPD test, no clinical features consistent with active TB, and a chest x-ray with no evidence of active TB at screening; or
- If the PPD test is positive and the patient has no medical history or chest x-ray findings consistent with active TB, the patient may have a QuantiFERON®-TB Gold test or T-SPOT®.TB test (as available and if compliant with local TB guidelines). If the test results are not negative, the patient will be considered to have latent TB (for purposes of this study); or
- QuantiFERON®-TB Gold test or T- SPOT®.TB test (as available and if compliant with local TB guidelines) may be used instead of the PPD test. If the test results are positive, the patient will be considered to have latent TB. If the test is not negative, the test may be repeated once within approximately 2 weeks of the initial value. If the repeat test results are again not negative, the patient will be considered to have latent TB (for purposes of this study).
- Have been exposed to a live vaccine within 12 weeks of randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination).
- Have donated more than a single unit of blood within 4 weeks prior to screening or intend to donate blood during the course of the study.
- Have a history of intravenous drug abuse, other illicit drug abuse, or chronic alcohol abuse within the 2 years prior to screening or are concurrently using, or expected to use during the study, illicit drugs (including marijuana).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deucravacitinib (BMS-986165) in the Treatment of Pityriasis Rubra Pilaris
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
- Being tested
- Deucravacitinib
- Medical subject headings
- Pityriasis Rubra Pilaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
6 mg administered orally twice daily for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pityriasis Rubra Pilaris | Experimental | Subjects will receive Deucravacitinib, twice daily for 24 weeks Receives: Drug: Deucravacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psoriasis Area and Severity Index (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.
Measured: Baseline, 24 weeks
Secondary outcomes (6)
Change in Patient´s Assessment of Itch as Measured by Numeric Rating Scale
The Itch Numeric Rating Scale is a self-administered patient-reported outcome instrument used to assess the severity of itching in patients with atopic dermatitis. It asks patients to rate their worst level of itching in the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst itch imaginable), with higher scores indicating a worse itch.
Measured: Baseline, 24 weeks
Change in the Dermatology Life Quality Index (DLQI)
The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Measured: Baseline, 24 weeks
Change in the Skindex-16
Skindex-16 consists of domain scores that assess how symptoms, emotions, and functioning from the skin issue affect the QOL of patients with skin conditions. The overall score averages the 3 domain scores, all of which are normalized to a 0 to 100 scale, where 0 indicates that their skin condition has no impact on QOL and 100 represents maximal impact on QOL for the worse.
Measured: Baseline, 24 weeks
Number of Subject's Who Were Responsive to Treatment Based on the Physician Global Assessment (PGA)
The Physician Global Assessment (PGA) is a clinician-reported tool used to evaluate a patient's overall disease severity and overall treatment response at a given point in time. The clinician rates a patient's overall disease severity and overall treatment response from +4 (markedly improved) to -4 (markedly worse). A treatment response is defined as a score of +1 or higher.
Measured: Baseline; 24 weeks
Change in Total Body Surface Area (BSA) Affected by Pityriasis Rubra Pilaris
Body Surface Area is an investigator-estimated measure of the extent of skin involvement from pityriasis rubra pilaris. The percentage of total body surface area affected was recorded for the head, upper limbs, trunk, and lower limbs and combined to obtain total affected BSA. Change from baseline was calculated as the follow-up value (week 24) minus the baseline value; negative values indicate improvement.
Measured: Baseline; Week 24
Change in Regional Body Surface Area (BSA) Affected by Pityriasis Rubra Pilaris (PRP)
Regional Body Surface Area is an investigator-estimated measure of the extent of skin involvement from pityriasis rubra pilaris (PRP). For each body region, the percentage points of the participant's total body surface area affected by PRP were estimated using the Rule of Nines (head: 0-9%; upper limbs: 0-18%; trunk: 0-36%; lower limbs: 0-36%). Change from baseline was calculated as week 24 value minus the baseline value; negative values indicate improvement. Values represent percentage points of total body surface area affected rather than percent change from a previous assessment.
Measured: Baseline; 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start29 Jul 2024
- Primary completion2 Sep 2025
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pityriasis Rubra PilarisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron R. Mangold, Mayo Clinic
- Investigators
- Aaron Mangold, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444399
- Sponsor's protocol ID
- 23-012923
- Status last verified
- Aug 2026
- First submitted
- 31 May 2024
- Last updated
- 26 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deucravacitinib (BMS-986165) in the Treatment of Pityriasis Rubra Pilaris
- ClinicalTrials.gov ID
- NCT06444399
- Acronym / sponsor ID
- 23-012923
- Conditions
- Pityriasis Rubra Pilaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 2 Sep 2025 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 5 Jun 2024 (actual)
- Results
- Posted 26 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pityriasis Rubra Pilaris | Experimental | Drug: DeucravacitinibSubjects will receive Deucravacitinib, twice daily for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (46 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deucravacitinib6 mg administered orally twice daily for 24 weeks. | Drug | Pityriasis Rubra Pilaris |
Primary outcome
Change in Psoriasis Area and Severity Index (PASI) Scores
Time frame: Baseline, 24 weeks
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.
6 secondary outcomes
Change in Patient´s Assessment of Itch as Measured by Numeric Rating Scale
Time frame: Baseline, 24 weeks
Change in the Dermatology Life Quality Index (DLQI)
Time frame: Baseline, 24 weeks
Change in the Skindex-16
Time frame: Baseline, 24 weeks
Number of Subject's Who Were Responsive to Treatment Based on the Physician Global Assessment (PGA)
Time frame: Baseline; 24 weeks
Change in Total Body Surface Area (BSA) Affected by Pityriasis Rubra Pilaris
Time frame: Baseline; Week 24
Change in Regional Body Surface Area (BSA) Affected by Pityriasis Rubra Pilaris (PRP)
Time frame: Baseline; 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pityriasis Rubra Pilaris
Not yet recruitingPhase 4
Bimzelx (Bimekizumab) For The Treatment Of Adult Onset Pityriasis Rubra Pilaris (PRP)
Pityriasis Rubra Pilaris
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Mangold, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deucravacitinib in people with Pityriasis Rubra Pilaris, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psoriasis Area and Severity Index (PASI) Scores (time frame: Baseline, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.