💬In plain words
What the trial is, and whether it could suit you
The purpose of this study is to evaluate the efficacy and safety of IMC-002 and IMM0306S in the treatment of active SLE.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Has had a diagnosis of SLE for at least 12 weeks prior to the screening Visit.
* SLEDAI-2000 score ≥8. For screening eligibility only, headache and fever items shall be excluded from SLEDAI-2K scoring. Skin lesions shall meet morphological and distributive characteristics of active cutaneous lupus, with a total active Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) score ≥2.
* BILAG-2004 organ system scores of at least 1 A or 2 B at screening.
* Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
* Other protocol defined inclusion criteria may apply.
Exclusion Criteria:
* Active or unstable neuropsychiatric SLE or lupus nephritis
* Autoimmune or rheumatic disease other than SLE
* Significant, uncontrolled medical conditions not related to SLE
* Active and/or severe viral, bacterial or fungal infection
* History of malignancy within 5 years
* Other protocol defined exclusion criteria may apply.
💊
What it tests
- IMC-002 + SOC
- Placebo + SOC
- IMM0306S + SOC
Peking University People's Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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