EICHORCondition: Systemic Lupus Erythematosus · Sponsor: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
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The purpose of this study is to evaluate the efficacy and safety of IMC-002 and IMM0306S in the treatment of active SLE.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Peking University People's Hospital | Beijing, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06535412