Tests CM313 injection in people with systemic lupus erythematosus
Tests the CM313 injection against a placebo in adults with lupus.
Plain-language title generated from the registry record
Registry title: Study of CM313(SC) Injection in Systemic Lupus Erythematosus(SLE)
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06791772, who can take part
Where in China
- Peking Union Medical College HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Keymed Biosciences Co.Ltd
- Trial code
- NCT06791772
- Record updated
- 24 January 2025
- Original description
To evaluate the efficacy and safety of CM313(SC) injection in systemic lupus erythematosus(SLE)Read full original descriptionShow less
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM313(SC) Injection in Subjects With Systemic Lupus Erythematosus
To evaluate the efficacy and safety of CM313(SC) injection in systemic lupus erythematosus(SLE)
Inclusion: Males or females aged 18 to 65 years; Voluntarily signed the informed consent form (ICF); 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; 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; 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; ≥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; Maintain a stable standard treatment regimen for at least 30 days prior to initial dosing of the investigational product.
Exclusion: Kidney disease: Severe lupus nephritis within within 8 weeks prior to randomization; Patients with systemic lupus erythematosus(SLE) or non-SLE related central nervous system disease within 8 weeks prior to randomization; There were non-SLE inflammatory skin or joint diseases that the investigators thought might be evaluated during the screening period; History of clinically significant diseases.