A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus (NCT06535412) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
China218 participantsStarted 2024-10-10
Plain-language summary
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 participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.