Trial Outcomes & Findings for Deucravacitinib (BMS-986165) for Pityriasis Rubra Pilaris (NCT NCT06444399)

Last Updated: 2026-08-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Baseline, 24 weeks

Results posted on

2026-08-26

Participant Flow

7 subjects were enrolled in the study; however, 1 subject was excluded prior to receiving the study drug due to subject withdrawal.

Participant milestones

Participant milestones
Measure	Pityriasis Rubra Pilaris Subjects received Deucravacitinib, twice daily for 24 weeks Deucravacitinib: 6 mg administered orally twice daily for 24 weeks.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Deucravacitinib (BMS-986165) for Pityriasis Rubra Pilaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pityriasis Rubra Pilaris n=6 Participants Subjects received Deucravacitinib, twice daily for 24 weeks Deucravacitinib: 6 mg administered orally twice daily for 24 weeks.
Age, Continuous	59.0 years STANDARD_DEVIATION 9.5 • n=31 Participants
Sex: Female, Male Female	1 Participants n=31 Participants
Sex: Female, Male Male	5 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	1 Participants n=31 Participants
Race (NIH/OMB) White	5 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=31 Participants
Region of Enrollment United States	6 participants n=31 Participants

PRIMARY outcome

Timeframe: Baseline, 24 weeks

Outcome measures

Outcome measures
Measure	Pityriasis Rubra Pilaris n=6 Participants Subjects received Deucravacitinib, twice daily for 24 weeks Deucravacitinib: 6 mg administered orally twice daily for 24 weeks.
Change in Psoriasis Area and Severity Index (PASI) Scores	-22.2 score on a scale Standard Deviation 12.9

SECONDARY outcome

Timeframe: Baseline, 24 weeks

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.

Outcome measures

Outcome measures
Measure	Pityriasis Rubra Pilaris n=6 Participants Subjects received Deucravacitinib, twice daily for 24 weeks Deucravacitinib: 6 mg administered orally twice daily for 24 weeks.
Change in Patient´s Assessment of Itch as Measured by Numeric Rating Scale	-3.2 score on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: Baseline, 24 weeks

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.

Outcome measures

Outcome measures
Measure	Pityriasis Rubra Pilaris n=6 Participants Subjects received Deucravacitinib, twice daily for 24 weeks Deucravacitinib: 6 mg administered orally twice daily for 24 weeks.
Change in the Dermatology Life Quality Index (DLQI)	-12.7 score on a scale Standard Deviation 10.0

SECONDARY outcome

Timeframe: Baseline, 24 weeks

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.

Outcome measures

Outcome measures
Measure	Pityriasis Rubra Pilaris n=6 Participants Subjects received Deucravacitinib, twice daily for 24 weeks Deucravacitinib: 6 mg administered orally twice daily for 24 weeks.
Change in the Skindex-16	-36.2 score on a scale Standard Deviation 29.4

SECONDARY outcome

Timeframe: Baseline; 24 weeks

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.

Outcome measures

Outcome measures
Measure	Pityriasis Rubra Pilaris n=6 Participants Subjects received Deucravacitinib, twice daily for 24 weeks Deucravacitinib: 6 mg administered orally twice daily for 24 weeks.
Number of Subject's Who Were Responsive to Treatment Based on the Physician Global Assessment (PGA)	4 Participants

SECONDARY outcome

Timeframe: Baseline; Week 24

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.

Outcome measures

Outcome measures
Measure	Pityriasis Rubra Pilaris n=6 Participants Subjects received Deucravacitinib, twice daily for 24 weeks Deucravacitinib: 6 mg administered orally twice daily for 24 weeks.
Change in Total Body Surface Area (BSA) Affected by Pityriasis Rubra Pilaris	-51.5 percentage of total BSA affected Standard Deviation 36.1

SECONDARY outcome

Timeframe: Baseline; 24 Weeks

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.

Outcome measures

Outcome measures
Measure	Pityriasis Rubra Pilaris n=6 Participants Subjects received Deucravacitinib, twice daily for 24 weeks Deucravacitinib: 6 mg administered orally twice daily for 24 weeks.
Change in Regional Body Surface Area (BSA) Affected by Pityriasis Rubra Pilaris (PRP) Head BSA	-4.7 percentage points of total BSA affected Standard Deviation 4.1
Change in Regional Body Surface Area (BSA) Affected by Pityriasis Rubra Pilaris (PRP) Upper-limb BSA	-9.1 percentage points of total BSA affected Standard Deviation 8.1
Change in Regional Body Surface Area (BSA) Affected by Pityriasis Rubra Pilaris (PRP) Trunk BSA	-15.6 percentage points of total BSA affected Standard Deviation 14.4
Change in Regional Body Surface Area (BSA) Affected by Pityriasis Rubra Pilaris (PRP) Lower-limb BSA	-22.2 percentage points of total BSA affected Standard Deviation 12.3

Adverse Events

Pityriasis Rubra Pilaris

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pityriasis Rubra Pilaris n=6 participants at risk Subjects received Deucravacitinib, twice daily for 24 weeks Deucravacitinib: 6 mg administered orally twice daily for 24 weeks.
Skin and subcutaneous tissue disorders Impetigo	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Skin and subcutaneous tissue disorders Atopic Dermatitis	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Skin and subcutaneous tissue disorders Basel Cell Carcinoma	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Infections and infestations Common Cold	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Gastrointestinal disorders Diarrhea	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Ear and labyrinth disorders Ear fullness/tinnitus	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Investigations Elevated Creatinine	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Investigations Elevated Creatinine Kinase	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
General disorders Fatigue	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Nervous system disorders Headache	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Musculoskeletal and connective tissue disorders Joint Pain	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
General disorders Loss of Appetite	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Gastrointestinal disorders Nausea	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
General disorders Pain	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Skin and subcutaneous tissue disorders Periocular dermatitis	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Skin and subcutaneous tissue disorders Pruritus	66.7% 4/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Respiratory, thoracic and mediastinal disorders Sore Throat	33.3% 2/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Skin and subcutaneous tissue disorders Squamous Cell Carcinoma In Situ	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Infections and infestations Upper Respiratory Tract Infection/Nasopharyngitis	33.3% 2/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.
Musculoskeletal and connective tissue disorders Worsening Rheumatoid Arthritis	16.7% 1/6 • Adverse events were collected from the time of informed consent through study completion, approximately 28 weeks. At each contact with the subject, the study team sought information on adverse events by specific questioning and, as appropriate, by examination.

Additional Information

Aaron Mangold, M.D.

Mayo Clinic

Phone: 480-301-6169

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place