Long-Term Safety and Efficacy of BMS-986165 in Subjects with Psoriasis

An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000612-29-CZ

Enrollment

1560

Registered

2019-11-12

Start date

2020-02-10

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Moderate-to-Severe Plaque Psoriasis

Interventions

Product Name: BMS-986165 Product Code: BMS-986165 Pharmaceutical Form: Film-coated tablet CAS Number: 1609392-28-0 Current Sponsor code: BMS986165 Other descriptive name: BMS986165 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis 2) Subjects must be willing to participate in IM011075 and must have the ability to sign the informed consent form (ICF). 3) Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the study period (must have a negative urine pregnancy test 24 hours prior to the start of study drug. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1404 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 156

Exclusion criteria

Exclusion criteria: 1) Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or is considered unsuitable by the investigator for any other reason 2) Prior permanent discontinuation of study treatment in the parent study 3) Findings Related to Possible TB Infection 4) Evidence of active TB

Design outcomes

Primary

Measure	Time frame
Main Objective: To characterize the safety and tolerability of long-term use of BMS-986165 in subjects with moderate-to-severe plaque psoriasis;Secondary Objective: To characterize the maintenance of response to BMS-986165 in the treatment of subjects with moderateto- severe plaque psoriasis;Primary end point(s): Adverse events and serious adverse events;Timepoint(s) of evaluation of this end point: Each visit (10)	—

Measure

Time frame

Main Objective: To characterize the safety and tolerability of long-term use of BMS-986165 in subjects with moderate-to-severe plaque psoriasis;Secondary Objective: To characterize the maintenance of response to BMS-986165 in the treatment of subjects with moderateto- severe plaque psoriasis;Primary end point(s): Adverse events and serious adverse events;Timepoint(s) of evaluation of this end point: Each visit (10)

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Secondary

Measure	Time frame
Secondary end point(s): sPGA 0/1 response PASI 75 response sPGA 0 response PASI 90 response PASI 100 response Change from baseline and percent change from baseline in BSA Change from baseline in PSSD total score Change from baseline in PSSD symptom score Change from baseline in PSSD sign score PSSD total score of 0 PSSD symptom score of 0 PSSD sign score of 0 Change from baseline in DLQI score DLQI 0/1 EQ-5D-3L Change from baseline in WLQ score ss-PGA 0/1 response PGA-F 0/1 response;Timepoint(s) of evaluation of this end point: Please see schedule of events in the Protocol for timepoints.	—

Measure

Time frame

Secondary end point(s): sPGA 0/1 response PASI 75 response sPGA 0 response PASI 90 response PASI 100 response Change from baseline and percent change from baseline in BSA Change from baseline in PSSD total score Change from baseline in PSSD symptom score Change from baseline in PSSD sign score PSSD total score of 0 PSSD symptom score of 0 PSSD sign score of 0 Change from baseline in DLQI score DLQI 0/1 EQ-5D-3L Change from baseline in WLQ score ss-PGA 0/1 response PGA-F 0/1 response;Timepoint(s) of evaluation of this end point: Please see schedule of events in the Protocol for timepoints.

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Countries

Australia, Canada, China, Czechia, Czech Republic, Finland, France, Germany, Hungary, Israel, Japan, Korea, Republic of, New Zealand, Poland, Russian Federation, Spain, Sweden, Taiwan, United Kingdom, United States

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026