Trial Outcomes & Findings for An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe Psoriasis (NCT NCT03924427)

Results Overview

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as clear (0) or almost clear (1) with at least 2-point improvement from baseline at week 16 using the non-responder imputation (NRI) method. The higher sPGA score denotes to more severe disease activity: * Clear (0) * Almost clear (1) * Mild (2) * Moderate (3) * Severe (4)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

74 participants

Primary outcome timeframe

Week 16

Results posted on

2022-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Deucravacitinib 6 mg QD Deucravacitinib (BMS-986165) 6 mg once daily (QD)
Overall Study STARTED	74
Overall Study COMPLETED	68
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Deucravacitinib 6 mg QD Deucravacitinib (BMS-986165) 6 mg once daily (QD)
Overall Study Adverse Event	4
Overall Study Lack of Efficacy	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Deucravacitinib 6 mg QD n=74 Participants Deucravacitinib (BMS-986165) 6 mg once daily (QD)
Age, Continuous	48.6 Years STANDARD_DEVIATION 11.72 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese	73 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Non-Japanese	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: All treated participants

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as clear (0) or almost clear (1) with at least 2-point improvement from baseline at week 16 using the non-responder imputation (NRI) method. The higher sPGA score denotes to more severe disease activity: * Clear (0) * Almost clear (1) * Mild (2) * Moderate (3) * Severe (4)

Outcome measures

Outcome measures
Measure	Plaque Psoriasis 6 mg QD n=63 Participants Subgroup of the all treated population with plaque psoriasis that received Deucravacitinib (BMS-986165) 6 mg once daily (QD)	Generalized Pustular Psoriasis 6 mg QD n=3 Participants Subgroup of the all treated population with generalized pustular psoriasis that received Deucravacitinib (BMS-986165) 6 mg once daily (QD)	Erythrodemic Psoriasis 6 mg QD n=8 Participants Subgroup of the all treated population with Erythrodemic psoriasis that received Deucravacitinib (BMS-986165) 6 mg once daily (QD)
Static Physician's Global Assessment (sPGA) 0/1 Response as a Number of Participants With a sPGA Score of 0 or 1 at Week 16	52 Participants	0 Participants	4 Participants

PRIMARY outcome

Timeframe: Week 16

Population: All treated participants

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method.

Outcome measures

Outcome measures
Measure	Plaque Psoriasis 6 mg QD n=63 Participants Subgroup of the all treated population with plaque psoriasis that received Deucravacitinib (BMS-986165) 6 mg once daily (QD)	Generalized Pustular Psoriasis 6 mg QD n=3 Participants Subgroup of the all treated population with generalized pustular psoriasis that received Deucravacitinib (BMS-986165) 6 mg once daily (QD)	Erythrodemic Psoriasis 6 mg QD n=8 Participants Subgroup of the all treated population with Erythrodemic psoriasis that received Deucravacitinib (BMS-986165) 6 mg once daily (QD)
Psoriasis Area and Severity Index (PASI) 75 Response Assessed as a Number of Participants Who Achieve a 75% Improvement From Baseline in the PASI Score at Week 16	48 Participants	2 Participants	3 Participants

Adverse Events

Deucravacitinib 6 mg QD

Serious events: 5 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Deucravacitinib 6 mg QD n=74 participants at risk Deucravacitinib (BMS-986165) 6 mg once daily (QD)
Infections and infestations COVID-19	1.4% 1/74 • Serious Adverse Events and Adverse Events were monitored from first dose to 30 days post last dose (Up to approximately 3 months). Participants were assessed for All Cause Mortality from their date of randomization until study completion (Up to approximately 23 months)
Infections and infestations Pneumonia	1.4% 1/74 • Serious Adverse Events and Adverse Events were monitored from first dose to 30 days post last dose (Up to approximately 3 months). Participants were assessed for All Cause Mortality from their date of randomization until study completion (Up to approximately 23 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	1.4% 1/74 • Serious Adverse Events and Adverse Events were monitored from first dose to 30 days post last dose (Up to approximately 3 months). Participants were assessed for All Cause Mortality from their date of randomization until study completion (Up to approximately 23 months)
Nervous system disorders Normal pressure hydrocephalus	1.4% 1/74 • Serious Adverse Events and Adverse Events were monitored from first dose to 30 days post last dose (Up to approximately 3 months). Participants were assessed for All Cause Mortality from their date of randomization until study completion (Up to approximately 23 months)
Respiratory, thoracic and mediastinal disorders Asthma	1.4% 1/74 • Serious Adverse Events and Adverse Events were monitored from first dose to 30 days post last dose (Up to approximately 3 months). Participants were assessed for All Cause Mortality from their date of randomization until study completion (Up to approximately 23 months)

Other adverse events

Other adverse events
Measure	Deucravacitinib 6 mg QD n=74 participants at risk Deucravacitinib (BMS-986165) 6 mg once daily (QD)
Gastrointestinal disorders Constipation	5.4% 4/74 • Serious Adverse Events and Adverse Events were monitored from first dose to 30 days post last dose (Up to approximately 3 months). Participants were assessed for All Cause Mortality from their date of randomization until study completion (Up to approximately 23 months)
Gastrointestinal disorders Stomatitis	5.4% 4/74 • Serious Adverse Events and Adverse Events were monitored from first dose to 30 days post last dose (Up to approximately 3 months). Participants were assessed for All Cause Mortality from their date of randomization until study completion (Up to approximately 23 months)
Infections and infestations Nasopharyngitis	31.1% 23/74 • Serious Adverse Events and Adverse Events were monitored from first dose to 30 days post last dose (Up to approximately 3 months). Participants were assessed for All Cause Mortality from their date of randomization until study completion (Up to approximately 23 months)
Infections and infestations Periodontitis	5.4% 4/74 • Serious Adverse Events and Adverse Events were monitored from first dose to 30 days post last dose (Up to approximately 3 months). Participants were assessed for All Cause Mortality from their date of randomization until study completion (Up to approximately 23 months)
Infections and infestations Upper respiratory tract infection	5.4% 4/74 • Serious Adverse Events and Adverse Events were monitored from first dose to 30 days post last dose (Up to approximately 3 months). Participants were assessed for All Cause Mortality from their date of randomization until study completion (Up to approximately 23 months)
Skin and subcutaneous tissue disorders Acne	9.5% 7/74 • Serious Adverse Events and Adverse Events were monitored from first dose to 30 days post last dose (Up to approximately 3 months). Participants were assessed for All Cause Mortality from their date of randomization until study completion (Up to approximately 23 months)
Skin and subcutaneous tissue disorders Psoriasis	5.4% 4/74 • Serious Adverse Events and Adverse Events were monitored from first dose to 30 days post last dose (Up to approximately 3 months). Participants were assessed for All Cause Mortality from their date of randomization until study completion (Up to approximately 23 months)

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email:

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
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Restriction type: OTHER