A Study of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus

Launched by IMMUNECARE BIOPHARMACEUTICALS (SHANGHAI) CO., LTD. · Jul 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IMC-002 for people with active Systemic Lupus Erythematosus (SLE), an autoimmune disease that can affect various parts of the body. The goal of the study is to see how effective and safe IMC-002 is for managing the symptoms of SLE. The trial is currently not recruiting participants, but when it begins, it will look for adults aged 18 and older who have been diagnosed with SLE for at least 12 weeks and have a certain level of disease activity measured by specific scoring systems.

To be eligible for the study, participants must be currently taking at least one standard SLE medication, like corticosteroids or immunosuppressants. However, those with certain serious complications from SLE, other autoimmune diseases, or significant health issues unrelated to SLE won't be able to join. Participants in the trial can expect to receive the study treatment and will be closely monitored by medical professionals to assess how well the treatment works and if there are any side effects. This study is an important step in finding better treatments for those living with SLE.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Has had a diagnosis of SLE for at least 12 weeks prior to the screening Visit.
• • SLEDAI total score ≥ 6 at screening
• • 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.