IMC-002 and IMM0306S for active systemic lupus erythematosus
Official title: 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
Run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · NCT06535412 · Data updated 2026-11-12
This study tests IMC-002 and IMM0306S to see if they help adults with active lupus while they continue their usual medications.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 218 (estimated) |
| Sponsor | ImmuneOnco Biopharmaceuticals (Shanghai) Inc. Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | October 10, 2024 |
| Main results expected | December 17, 2028 |
| Study ends | December 17, 2028 |
| Registry record updated | June 29, 2026 |
| Trial ID | NCT06535412 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with moderate-to-severe active SLE (SLEDAI-2000 ≥8, CLASI ≥2, BILAG-2004 scores ≥1 A or ≥2 B) already taking standard SLE therapies.
✕Probably not a fit
Patients with active neuropsychiatric lupus, lupus nephritis, or other major uncontrolled conditions may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This two-stage, multicenter study first tests different doses of IMC-002 and IMM0306S in adults with active SLE to identify safe and potentially effective doses and to understand how the drugs behave in the body. It then randomizes participants to IMC-002 or IMM0306S versus placebo, in a double-blind design, to compare efficacy and safety when added to standard of care. Key goals include determining the RP2D, comparing 1.2 mg/kg and 1.6 mg/kg IMC-002 against placebo, and assessing population pharmacokinetics for IMM0306S. Eligible participants have active SLE with specific disease activity scores and are on background SLE therapy; major exclusions include active neuropsychiatric lupus, lupus nephritis, other autoimmune diseases, uncontrolled conditions, active infections, and recent malignancy.
Why it matters
Potential benefit: If successful, participants with active SLE may experience better disease control on top of their current medications.
How similar studies have gone: Previous dose-escalation and randomized SLE studies have shown potential signals with similar biologics, but this specific combination and design are novel for IMC-002/IMM0306S.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Peking University People's Hospital
Beijing, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.