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

An Open-Label, Single-arm, Multi-Center, Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Japanese Subjects with Moderate-to-Severe Psoriasis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224603

Enrollment

Registered

2019-03-20

Start date

2019-04-10

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 : deucruvacitinib Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administratio

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1.Guttate, inverse, or drug-induced psoriasis at Screening or Baseline 2.History of recent infection 3.Prior exposure to BMS-986165

Design outcomes

Primary

Measure	Time frame
efficacy - sPGA 0/1 response assessed as a proportion of subjects with a sPGA score of 0 or 1 at Week 16 - PASI 75 response assessed as a proportion of subjects who achieve a 75% improvement from baseline in the PASI score at Week 16	—

Secondary

Measure	Time frame
safety efficacy The following additional endopoints will be meaured through Week 52 -Percentage of participants who achieve sPGA score of 0 or 1 response -Percentage of participants who achieve PASI 75 -Percentage of participants who achieve PASI 90 -Percentage of participants who achieve PASI 100 -American College of Rheumatology Criteria (ACR20) response in participants with psoriatic arthritis -Change from baseline in the ACR core set in participants with psoriatic arthritis -Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) score -Percentage of participants who achieve Scalp Specific (ss)-PGA score 0 or 1 among participants with a baseline ss-PGA score more than 3 -Percentage of participants who achieve PGA-F score 0 or 1 among participants with a baseline PGA-F score more than 3 -Percentage of participants who achieve palmoplantar (pp)-PGA score of 0 or 1 among participants with a baseline pp-PGA score more than 3	—

Measure

Time frame

safety efficacy The following additional endopoints will be meaured through Week 52 -Percentage of participants who achieve sPGA score of 0 or 1 response -Percentage of participants who achieve PASI 75 -Percentage of participants who achieve PASI 90 -Percentage of participants who achieve PASI 100 -American College of Rheumatology Criteria (ACR20) response in participants with psoriatic arthritis -Change from baseline in the ACR core set in participants with psoriatic arthritis -Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) score -Percentage of participants who achieve Scalp Specific (ss)-PGA score 0 or 1 among participants with a baseline ss-PGA score more than 3 -Percentage of participants who achieve PGA-F score 0 or 1 among participants with a baseline PGA-F score more than 3 -Percentage of participants who achieve palmoplantar (pp)-PGA score of 0 or 1 among participants with a baseline pp-PGA score more than 3

—

Countries

Japan

Outcome results

None listed

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