A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
Recruiting · NCT06535412 · Interventional (participants receive a specific treatment) · Lead sponsor: ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
IMC-002 + SOCIMM0306S + SOCPlacebo + SOC
What this trial is about
The purpose of this study is to evaluate the efficacy and safety of IMC-002 and IMM0306S in the treatment of active SLE.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Peking University People's Hospital - Beijing, China