Psoriasis
Conditions
Brief summary
The purpose of this study is to investigate BMS-986165 given to Japanese participants with moderate-to-severe psoriasis.
Interventions
DRUGBMS-986165
Oral tablet administration
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: a. For participants with plaque psoriasis: i. Stable plaque psoriasis for at least 6 months ii. Moderate to severe disease iii. Candidate for phototherapy or systemic therapy b. Additional protocol-specified inclusion criteria apply for subjects with psoriatic arthritis, erythrodermic psoriasis, or generalized pustular psoriasis
Exclusion criteria
1. Guttate, inverse, or drug-induced psoriasis at Screening or Baseline 2. History of recent infection 3. Prior exposure to BMS-986165 Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 16 | 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) |
| 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 | Week 16 | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Deucravacitinib 6 mg QD Deucravacitinib (BMS-986165) 6 mg once daily (QD) | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Deucravacitinib 6 mg QD |
|---|---|
| Age, Continuous | 48.6 Years STANDARD_DEVIATION 11.72 |
| Race/Ethnicity, Customized Asian - Japanese | 73 Participants |
| Race/Ethnicity, Customized Asian - Non-Japanese | 1 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 74 |
| other Total, other adverse events | 40 / 74 |
| serious Total, serious adverse events | 5 / 74 |
Outcome results
Primary
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
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.
Time frame: Week 16
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plaque Psoriasis 6 mg 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 |
| Generalized Pustular Psoriasis 6 mg 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 | 2 Participants |
| Erythrodemic Psoriasis 6 mg 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 | 3 Participants |
Primary
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
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)
Time frame: Week 16
Population: All treated participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plaque Psoriasis 6 mg 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 |
| Generalized Pustular Psoriasis 6 mg 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 | 0 Participants |
| Erythrodemic Psoriasis 6 mg 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 | 4 Participants |