Clinical Trials List
2024-10-01 - 2027-12-31
Phase II
Not yet recruiting5
Recruiting1
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, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients with Systemic Lupus Erythematosus
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Sponsor
PPD DEVELOPMENT (HK) LIMITED TAIWAN BRANCH
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/14
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Tzn-Min Lin Division of Rheumatology
- 李向嚴 Division of Rheumatology
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 Recruiting
Co-Principal Investigator
- Wei-Sheng Chen Division of Rheumatology
- Chien-Chih Lai Division of Rheumatology
- Hsien-Tzung Liao Division of Rheumatology
- 曹彥博 Division of Rheumatology
- Yi-Syuan Sun Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Ping-Han Tsai Division of Rheumatology
- 陳彥輔 Division of Rheumatology
- 張哲慈 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 EULAR/ACR classification criteria.
Patient has all 3 of the following based on features active on the day of the visits:
hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 at Day 1 Note: Clinical points exclude laboratory tests, except proteinuria.
BILAG-2004 Grade A or B in ≥ 1 organ system at screening and Day 1.
In the opinion of the investigator and the central adjudicator, there is sufficient disease activity to warrant enrollment into a clinical study with an investigational agent.
Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant.
Exclusion Criteria
A history of thrombosis or embolism in the previous 6 months before the Screening visit, or previous 12 months associated with antiphospholipid syndrome (APS) or another relevant hypercoagulable state.
Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as, but not limited to, psoriasis, dermatomyositis, and systemic sclerosis.
Active severe neuropsychiatric or central nervous system SLE.
Current inflammatory disease other than SLE (including, but not limited to, rheumatoid arthritis, psoriatic arthritis, spondyloarthropathy, reactive arthritis, scleroderma, dermatomyositis) that may interfere with the assessment of lupus signs and symptoms in the opinion of the investigator or central adjudicator.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
190 participants
