Study of CM313(SC) Injection in Systemic Lupus Erythematosus(SLE)

Launched by KEYMED BIOSCIENCES CO.LTD · Jan 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called CM313(SC) injection for people with systemic lupus erythematosus (SLE), which is a disease that can cause inflammation and damage to various parts of the body, including the skin, joints, and organs. The main goal of the trial is to see how effective and safe this new treatment is for managing SLE symptoms. Although the trial is not yet recruiting participants, it is designed for adults between the ages of 18 and 65 who have been diagnosed with SLE and have certain levels of disease activity.

To be eligible for the study, participants must have a specific score indicating their disease activity and show certain lab results, such as positive antibody tests. They also need to have been on a stable treatment plan for at least 30 days before starting the trial. However, individuals with severe kidney issues or central nervous system diseases related to lupus in the recent past won't be eligible. If chosen to participate, individuals can expect to receive the CM313(SC) injection and will be closely monitored for any effects the treatment may have. This trial represents an important step in exploring new options for SLE patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males or females aged 18 to 65 years.
• • 2. Voluntarily signed the informed consent form (ICF).
• • 3. Patients were diagnosed with systemic lupus erythematosus(SLE) according to the diagnostic classification criteria of the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) in 2019.
• • 4. Systemic Lupus Erythematosus Disease Activity Index - 2000(SLEDAI-2K) score ≥6 during screening, and SLEDAI-2K clinical score (except for low complement and/or positive anti-dsDNA antibodies) ≥4 during screening and at baseline.
• • 5. Positive antinuclear antibody and/or anti-dsDNA antibody results defined in accordance with the laboratory reference value range of the Central laboratory during the screening.
• • 6. ≥1British Isles Lupus Assessment Group-2004 (BILAG-2004) organ system rated as A or ≥ 2 organ system rated as B, and Physician's Global Assessment(PGA) score ≥1.0 during screening.
• • 7. Maintain a stable standard treatment regimen for at least 30 days prior to initial dosing of the investigational product.
• Exclusion Criteria:
• • 1. Kidney disease: Severe lupus nephritis within within 8 weeks prior to randomization.
• • 2. Patients with systemic lupus erythematosus(SLE) or non-SLE related central nervous system disease within 8 weeks prior to randomization.
• • 3. There were non-SLE inflammatory skin or joint diseases that the investigators thought might be evaluated during the screening period.
• • 4. History of clinically significant diseases.