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
Zenas BioPharma (USA) LLC
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 張哲慈 Division of Rheumatology
- Ping-Han Tsai Division of Rheumatology
- 陳彥輔 Division of Rheumatology
- Shue-Fen Lo 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 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yi-Syuan Sun Division of Rheumatology
- Hsien-Tzung Liao Division of Rheumatology
- Wei-Sheng Chen Division of Rheumatology
- 曹彥博 Division of Rheumatology
- Chien-Chih Lai Division of Rheumatology
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
Week 24, defined according to the BILAG-
Based Composite Lupus Assessment (BICLA)
Response
Inclution Criteria
1. ≥ 18 to ≤ 70 years of age.
2. Capable of giving signed informed consent, which includes compliance with the requirements
and restrictions listed in the ICF.
3. Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 EULAR/ACR
classification criteria.
4. At screening, at least one of the following:
a) antinuclear antibody (ANA) ≥ 1:80
b) positive anti-dsDNA
c) positive anti-Sm
5. Patient has all 3 of the following based on features active on the day of the visits:
a) hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 at
Day 1.
Note: Clinical points exclude laboratory tests, except proteinuria.
Patients with proteinuria scored as present (i.e., urine protein/creatinine
> 500 mg/g) at screening will also be scored as present on Day 1 if a dipstick
performed at the site on Day 1 is at least 2+ proteinuria. If the urine
protein/creatinine > 500 mg/g at screening is not known to be stable based on
recent past proteinuria testing, then a repeat urine protein/creatinine measurement
is required during the Screening Period.
b) BILAG-2004 Grade A or B in ≥ 1 organ system at screening and Day 1.
c) 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.
6. Patients must be treated with one or more of the following background nonbiologic lupus
standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant.
The treatment regimen must be as below:
a) If taking oral corticosteroid: No increase in dosing regimen during the Screening
Period, and at stable dose ≤ 20 mg/day prednisone equivalent at least 2 weeks prior
to Day 1.
b) If taking antimalarial:
• No increase in dose within 8 weeks prior to the Screening visit.
• After the Screening visit (i.e., during the Screening Period and the Treatment
Period), dosing must be stable and as follows: hydroxychloroquine
≤ 400 mg/day, quinacrine ≤ 100 mg/day, or chloroquine ≤ 250 mg/day.
c) If taking immunosuppressant:
• No increase in dose within 8 weeks prior to the Screening visit
Exclusion Criteria
1. Active lupus nephritis for which, in the opinion of the investigator or the central adjudicator,
current medications are insufficient for patient’s safety or additional therapy that is not
permitted in the protocol is needed.
2. A history of thrombosis or embolism in the previous 6 months before the Screening visit, or
thrombotic history in the previous 12 months associated with antiphospholipid syndrome
(APS) or another relevant hypercoagulable state. A thrombotic history associated with APS or
another relevant hypercoagulable state more than 12 months prior to Screening visit is
excluded if it is not treated per local standards with prophylactic anticoagulation.
3. 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.
4. Active severe neuropsychiatric or central nervous system SLE.
5. 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. Current diagnosis of thyroiditis or secondary
Sjogren’s Syndrome is permitted.
6. Presence of uncontrolled or New York Heart Association Class III or IV congestive heart
failure.
7. Any condition or finding on physical exam, current or previous medical history, vital signs,
12-lead electrocardiogram, or laboratory tests that, in the opinion of the investigator or central
adjudicator, might interfere with the evaluation of the investigational product or should
otherwise exclude a patient.
8. Surgery (not considered minor by the investigator or the central adjudicator) within 4 weeks
before screening, or planned surgery during the study.
9. History of relevant allergies, including allergy to study drug or any murine or human-derived
protein or immunoglobulin products that, in the opinion of the investigator or central
adjudicator, make inclusion in the study inappropriate.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
190 participants
