NCT06535412 A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
| NCT ID | NCT06535412 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd. |
| Condition | Systemic Lupus Erythematosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 218 participants |
| Start Date | 2024-10-10 |
| Primary Completion | 2028-12-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 218 participants in total. It began in 2024-10-10 with a primary completion date of 2028-12-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of IMC-002 and IMM0306S in the treatment of active SLE.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT06535412 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06535412 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06535412 currently recruiting?
Yes, NCT06535412 is actively recruiting participants. Visit ClinicalTrials.gov or contact ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd. to inquire about joining.
Where is the NCT06535412 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06535412 clinical trial?
NCT06535412 is sponsored by ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.. The trial plans to enroll 218 participants.
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