Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986165 in Subjects With Moderate to Severe Psoriasis

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223467

Enrollment

250

Registered

2017-02-24

Start date

2017-02-24

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 Investiga

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of plaque psoriasis for 6 months Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test, must not be pregnant, lactating, breastfeeding or planning pregnancy Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of the study drug plus 90 days.

Exclusion criteria

Exclusion criteria: Any significant acute or chronic medical illness Blood transfusion within 4 weeks of study drug administration Inability to tolerate oral medication Positive hepatitis-B (HBV) surface antigen Positive hepatitis-C (HCV) antibody Any history or risk for tuberculosis (TB) Any major illness/condition or evidence of an unstable clinical condition Chest X-ray findings suspicious of infection at screening has received ustekinumab, secukinumab or ixekizumab within 6 months of first administration of study medication Has received anti-Tumor Necrosis Factor (TNF) inhibitor(s) within 2 months of first administration of study medication Has received Rituximab within 6 months of first administration of study medication Topical medications/treatments for psoriasis within 2 weeks of the first administration of any study medication Any systemic medications/treatments for psoriasis within 4 weeks of the first administration of any study medication

Design outcomes

Primary

Measure	Time frame
Proportion of subjects reaching a 75% reduction in Psoriasis Area and Severity Index (PASI-75) [ Time Frame: Day 1 to Day 85 ] Number of adverse events (AEs) [ Time Frame: Day 1 to 115 ]	—

Secondary

Measure	Time frame
Proportion of subjects at week 12 with PASI-50 [ Time Frame: Baseline to Week 12 ] Proportion of subjects at week 12 with PASI-75 [ Time Frame: Baseline to Week 12 ] Proportion of subjects at week 12 with PASI-90 [ Time Frame: Baseline to Week 12 ] Proportion of subjects at week 12 with PASI-100 [ Time Frame: Baseline to Week 12 ] static Physician Global Assessment score (sPGA) [ Time Frame: Day 1 to Day 85 ] Dermatology Life Quality Index score (DLQI) [ Time Frame: Day 1 to Day 85 ] Trough observed plasma concentration of BMS-986165 (Ctrough) [ Time Frame: Day 1 to Day 85 ]	—

Measure

Time frame

Proportion of subjects at week 12 with PASI-50 [ Time Frame: Baseline to Week 12 ] Proportion of subjects at week 12 with PASI-75 [ Time Frame: Baseline to Week 12 ] Proportion of subjects at week 12 with PASI-90 [ Time Frame: Baseline to Week 12 ] Proportion of subjects at week 12 with PASI-100 [ Time Frame: Baseline to Week 12 ] static Physician Global Assessment score (sPGA) [ Time Frame: Day 1 to Day 85 ] Dermatology Life Quality Index score (DLQI) [ Time Frame: Day 1 to Day 85 ] Trough observed plasma concentration of BMS-986165 (Ctrough) [ Time Frame: Day 1 to Day 85 ]

—

Outcome results

None listed

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