Clinical Trials List
2019-12-01 - 2026-07-31
Phase III
Not yet recruiting4
Recruiting3
ICD-10L40.50
Arthropathic psoriasis, unspecified
ICD-10L40.51
Distal interphalangeal psoriatic arthropathy
ICD-10L40.52
Psoriatic arthritis mutilans
ICD-10L40.53
Psoriatic spondylitis
ICD-10L40.54
Psoriatic juvenile arthropathy
ICD-10L40.59
Other psoriatic arthropathy
ICD-9696.0
Psoriatic arthropathy
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.
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Trial Applicant
Pharmaceutical Research Associates Taiwan Inc.
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Sponsor
Bristol-Myers Squibb
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 吳貞宜 無
- Chih-Chiang Chen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: 96 weeks ]
Secondary Outcome Measures :
static Physician Global Assessment (sPGA)0/1 response [ Time Frame: 96 weeks ]
Psoriasis Area and Severity Index (PASI) 75 response [ Time Frame: 96 weeks ]
Inclution Criteria
1) Signed Written Informed Consent
a) Subjects must be willing to participate in IM011075 and must have the ability to sign the
informed consent form (ICF).
2) Type of Subject and Target Disease Characteristics
a) Completion of the protocol-required treatment period in an applicable study of
BMS-986165 in moderate-to-severe psoriasis
3) Reproductive Status
a) Women of childbearing potential (WOCBP) must have a negative urine pregnancy test
(minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin within
24 hours prior to the start of study drug)
b) Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the
study period
c) Not applicable per Revised Protocol 5 (replaced by 3e below)
d) Not applicable per Revised Protocol 5 (replaced by 3f below)
e) WOCBP must agree to use correctly at minimum 1 of the less than highly effective
method(s) of contraception for the duration of treatment with study drug BMS-986165.
WOCBP who are continuously not heterosexually active are exempt from contraceptive
requirements but must still undergo pregnancy testing as described in this protocol
f) For male subjects who are sexually active with WOCBP, no additional contraceptive
measures are required to be used.
Exclusion Criteria
1) Medical History and Concurrent Diseases
a) 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
b) Prior permanent discontinuation of study treatment in the parent study
2) Findings Related to Possible TB Infection
a) Evidence of active TB
The Estimated Number of Participants
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Taiwan
17 participants
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Global
1950 participants
