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-DE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-12
• Last Update Posted: 31 July 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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