An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate to Severe Plaque Psoriasis

A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224152

Enrollment

600

Registered

2018-11-21

Start date

2018-08-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Interventions

investigational material(s) Generic name etc : BMS-986165 INN of investigational material : - Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Plaque psoriasis for at least 6 months Moderate to severe disease Candidate for phototherapy or systemic therapy

Exclusion criteria

Exclusion criteria: Other forms of psoriasis History of recent infection Prior exposure to BMS-986165 or active comparator

Design outcomes

Primary

Measure	Time frame
efficacy Percentage of participants who achieve static Physician's Global Assessment (sPGA) score of 0 to 1 response [ Time Frame: Baseline to Week 16 ] Percentage of participants who achieve PASI 75 (75% reduction in Psoriasis Area and Severity Index) [ Time Frame: Baseline to Week 16 ] The sPGA score is the investigator's assessment of a participant's psoriasis lesions at a given point in time. Overall lesions are graded and averaged for thickness, erythema, and scaling based on a 0 (normal) to 4 (severe) scale. The PASI is a scoring system used by investigators to grade the severity and extent of psoriatic lesions. In the PASI system, the body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved and scored for erythema, induration, and scaling to generate a composite PASI score that ranges from 0 (normal) to 72 (most severe).	—

Measure

Time frame

efficacy Percentage of participants who achieve static Physician's Global Assessment (sPGA) score of 0 to 1 response [ Time Frame: Baseline to Week 16 ] Percentage of participants who achieve PASI 75 (75% reduction in Psoriasis Area and Severity Index) [ Time Frame: Baseline to Week 16 ] The sPGA score is the investigator's assessment of a participant's psoriasis lesions at a given point in time. Overall lesions are graded and averaged for thickness, erythema, and scaling based on a 0 (normal) to 4 (severe) scale. The PASI is a scoring system used by investigators to grade the severity and extent of psoriatic lesions. In the PASI system, the body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved and scored for erythema, induration, and scaling to generate a composite PASI score that ranges from 0 (normal) to 72 (most severe).

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Secondary

Measure	Time frame
efficacy Percentage of participants who achieve PASI 90 [ Time Frame: Baseline to Week 16 ] Percentage of participants who achieve PASI 100 [ Time Frame: Baseline to Week 16 ] Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) score [ Time Frame: Baseline to Week 16 ] Percentage of participants who achieve scalp specific Physician's Global Assessment (ss-PGA) score 0 or 1 among participants with a baseline ss-PGA score more than 3 [ Time Frame: Baseline to Week 16 ] Change from baseline in Dermatology Life Quality Index (DLQI) score [ Time Frame: Baseline to Week 16 ] Percentage of participants who achieve Physician Global Assessment-Fingernails (PGA-F) score 0 or 1 among participants with a baseline PGA-F score more than 3 [ Time Frame: Baseline to Week 16 ] Percentage of participants who achieve palmoplantar Physician's Global Assessment (pp-PGA) score 0 or 1 among participants with a baseline pp- PGA score more than 3 [ Time Frame: Baseline to Week 16 ] Percentage of participants who achieve PASI 75 [ Time Frame: Baseline to Week 52 ] Percentage of participants who achieve PASI 90 [ Time Frame: Baseline to Week 52 ] Percentage of participants who achieve sPGA score of 0 or 1 response [ Time Frame: Baseline to Week 52 ] The PSSD is a participant questionnaire to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consists of 11 items covering various symptoms and patient-observable signs and averaged to generate a score from 0 (normal) to 10 (most severe). The ss-PGA measure is used to evaluate the overall disease severity of scalp psoriasis. Lesions are assessed by investigators in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 0 (normal) to 4 (severe) scale. The DLQI is a 10-item participant questionnaire that measures the impact of skin disease on a participant's quality of life. Each question is evaluated on a 4-point scale ranging from 0 to 3 and added to gene	—

Measure

Time frame

efficacy Percentage of participants who achieve PASI 90 [ Time Frame: Baseline to Week 16 ] Percentage of participants who achieve PASI 100 [ Time Frame: Baseline to Week 16 ] Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) score [ Time Frame: Baseline to Week 16 ] Percentage of participants who achieve scalp specific Physician's Global Assessment (ss-PGA) score 0 or 1 among participants with a baseline ss-PGA score more than 3 [ Time Frame: Baseline to Week 16 ] Change from baseline in Dermatology Life Quality Index (DLQI) score [ Time Frame: Baseline to Week 16 ] Percentage of participants who achieve Physician Global Assessment-Fingernails (PGA-F) score 0 or 1 among participants with a baseline PGA-F score more than 3 [ Time Frame: Baseline to Week 16 ] Percentage of participants who achieve palmoplantar Physician's Global Assessment (pp-PGA) score 0 or 1 among participants with a baseline pp- PGA score more than 3 [ Time Frame: Baseline to Week 16 ] Percentage of participants who achieve PASI 75 [ Time Frame: Baseline to Week 52 ] Percentage of participants who achieve PASI 90 [ Time Frame: Baseline to Week 52 ] Percentage of participants who achieve sPGA score of 0 or 1 response [ Time Frame: Baseline to Week 52 ] The PSSD is a participant questionnaire to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consists of 11 items covering various symptoms and patient-observable signs and averaged to generate a score from 0 (normal) to 10 (most severe). The ss-PGA measure is used to evaluate the overall disease severity of scalp psoriasis. Lesions are assessed by investigators in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 0 (normal) to 4 (severe) scale. The DLQI is a 10-item participant questionnaire that measures the impact of skin disease on a participant's quality of life. Each question is evaluated on a 4-point scale ranging from 0 to 3 and added to gene

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Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026