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New treatment option for Systemic Lupus Erythematosus
Official title A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT06535412
What this study is testing
What is IMC-002 + SOC?
IMC-002 + SOC is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for systemic lupus erythematosus.
Also referred to as IMM0306.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy and safety of IMC-002 and IMM0306S in the treatment of active SLE.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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 may apply.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.