Clinical Trials List
2015-01-01 - 2018-01-31
Phase II
Terminated4
ICD-10L93.0
Discoid lupus erythematosus
ICD-10L93.1
Subacute cutaneous lupus erythematosus
ICD-10L93.2
Other local lupus erythematosus
ICD-9695.4
Lupus erythematosus
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects with Active Systemic Lupus Erythematosus
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Trial Applicant
BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
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Sponsor
Bristol-Myers Squibb
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 黃建中 風濕免疫科
- Chung-Ming Huang 風濕免疫科
- Po-Hao Huang 風濕免疫科
- 吳柏樟 風濕免疫科
- Jiunn-Horng Chen 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Yao-Fan Fang Division of Rheumatology
- 郭宏輝 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 郭佑民 風濕免疫科
- PING-NING HSU 風濕免疫科
- CHENG-HAN WU 風濕免疫科
- CHIEH-YU SHEN 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The primary objective (to compare the BICLA response rate at Day 169 following 24-week
treatment with BMS-931699 or placebo administered on a stable background therapy) will be
measured by the following primary endpoint:
Proportion of subjects who achieve BICLA response (BICLA response rate) at Day 169.
Secondary Endpoint(s)
Efficacy Endpoints
Proportion of subjects who meet response criteria for the SLE Responder Index(4) [SRI(4)],
SRI(5) and SRI(6) at Day 169
Proportion of subjects who meet response criteria for the SLE Responder Index(4) [SRI(4)],
SRI(5) and SRI(6) at Day 85
Proportion of subjects with BICLA response at Day 85
Change from baseline in CLASI score at Day 85 and Day 169
Percentage of subjects with an improvement of >4 or a decrease of >50% from baseline in
their CLASI score at Day 85 and Day 169
Change from baseline in arthritis, as assessed by American College of Rheumatology (ACR)
28-joint count of tender and swollen joints at Day 85 and at Day 169
The change from baseline in the following other indices SLE activity over time:
The overall BILAG-2004 score
The overall SLEDAI-2K score
The overall MDGA score
The cumulative corticosteroid and immunosuppressant use over time
8.3.2.2 Safety Endpoints
Incidence and severity of all Adverse Events (AEs), Serious AEs, and pre-established Events
of Special Interest
Incidence and severity of clinically significant changes in vital signs
Incidence and severity of clinically significant electrocardiogram (ECG) abnormalities
Incidence and severity of clinically significant abnormalities in general laboratory tests
Inclution Criteria
• Male or female aged between 18 to 70 (included)
• Diagnosed with active systemic lupus erythematosus by a doctor
• Disease must be in patient's joints or on the skin at a minimum
• Taking other medications is allowed but some are excluded
Exclusion Criteria
• Diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis
• Diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus
The Estimated Number of Participants
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Taiwan
16 participants
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Global
350 participants
