NCT06535412RecruitingPhase 1/2
A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
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
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy and safety of IMC-002 and IMM0306S in the treatment of active SLE.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 218 (estimated)
- First submitted
- 30 Jul 2024
- Start date
- 10 Oct 2024
- Primary completion date
- 17 Dec 2028
- Lead sponsor
- ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
- Diseases
- Lupus (SLE)
- NCT number
- NCT06535412
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 218
- From 10 Oct 2024 to the primary completion date, 17 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Active or unstable neuropsychiatric SLE or lupus nephritis
- Other protocol defined exclusion criteria may apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.