A Phase 2 Study of Obexelimab in Patients with Systemic Lupus Erythematosus

JRCT ID: jRCT2011240033

Registered date:17/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Systemic Lupus Erythematosus
• Date of first enrollment: 25/10/2024
• Target sample size: 8
• Countries of recruitment: BELGIUM,Japan,BULGARIA,Japan,CANADA,Japan,CHINA,Japan,DENMARK,Japan,GERMANY,Japan,GREECE,Japan,ITALY,Japan,MEXICO,Japan,POLAND,Japan,PORTUGAL,Japan,ROMANIA,Japan,SOUTH AFRICA,Japan,SPAIN,Japan,TAIWAN,Japan,UNITED STATES,Japan
• Study type: Interventional
• Intervention(s): Obexelimab or placebo is administered as SC injections every 7 days.

Outcome(s)

• Primary Outcome: Proportion of patients who achieve a response according to the BILAG-Based Composite Lupus Assessment (BICLA) Response
• Secondary Outcome: Proportion of patients who achieve response according to the Systemic Lupus Erythematosus Responder Index 4 (SRI-4).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 70age 12month 4weeks old
• Gender: Both

Include criteria

1. Males and females, 18 years of age or over to 70 years of age or under
2. Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 EULAR/ACR classification criteria.
3. Patient has all 3 of the following based on features active on the day of the visits:
3-1. hSLEDAI is 6 or over and clinical hSLEDAI is 4 or over at screening, and clinical hSLEDAI is 4 or over at Day 1
Note: Clinical points exclude laboratory tests, except proteinuria.
3-2. BILAG-2004 Grade A or B in 1 or over organ system at screening and Day 1.
3-3. 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.
4. Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant.

Exclude 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 previous 12 months associated with antiphospholipid syndrome (APS) or another relevant hypercoagulable state.
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.

Related Information

• Primary Sponsor: Narita Wakako
• Secondary ID(s): NCT06559163