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

Phase 2

Not yet recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Placebo; Biological: CM313 injection

• Registration Number: NCT06791772
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

To evaluate the efficacy and safety of CM313(SC) injection in systemic lupus erythematosus(SLE)

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-19
• Study First Submitted QC: 2025-01-19
• Last Update Submitted: 2025-01-19
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Study Start: 2025-02
• Primary Completion: 2026-10
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Placebo	Placebo
Group A	CM313 injection	CM313
Group B	CM313 injection	CM313

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)	Up to week 24	SRI-4 response is defined as: * Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K) reduction from baseline of ≥ 4 points; * No British Isles Lupus Assessment Group-2004 (BILAG-2004) worsening, defined as ≥ 1 new A or ≥ 2 new B items compared to baseline; * No worsening in Physician's Global Assessment (PGA), defined as an increase of ≥ 0.3 from baseline

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China