Tests IMC-002 and IMM0306S in adults with active lupus
Tests IMC-002 and IMM0306S against placebo in adults with active systemic lupus.
Plain-language title generated from the registry record
Registry title: A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06535412, who can take part
Where in China
- Peking University People's HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
- Trial code
- NCT06535412
- Record updated
- 29 June 2026
- Original description
The purpose of this study is to evaluate the efficacy and safety of IMC-002 and IMM0306S in the treatment of active SLE.Read full original descriptionShow less
A Multi-center, Randomized, Double-blind, Placebo Control Phase 1b/II Study to Evaluate the Safety and Efficacy of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy and safety of IMC-002 and IMM0306S in the treatment of active SLE.
Inclusion: 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: 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; Active or unstable neuropsychiatric SLE or lupus nephritis; Other protocol defined exclusion criteria may apply.