NCT06791772Not yet recruitingPhase 2
Study of CM313(SC) Injection in Systemic Lupus Erythematosus(SLE)
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
Source: ClinicalTrials.gov · Last updated 24 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the efficacy and safety of CM313(SC) injection in systemic lupus erythematosus(SLE)
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 19 Jan 2025
- Start date
- Feb 2025
- Primary completion date
- Oct 2026
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Diseases
- Lupus (SLE)
- NCT number
- NCT06791772
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 150
- From Feb 2025 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.