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

Phase 1

Conditions: Moderate-to-Severe Plaque Psoriasis
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2019-000612-29-CZ

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1560

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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