Systemic Lupus Erythematosus
Conditions
Brief summary
To evaluate the efficacy and safety of CM313(SC) injection in systemic lupus erythematosus(SLE)
Interventions
BIOLOGICALCM313 injection
CM313 600mg（4ml）/vial. Subcutaneous injection 600mg. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses.
DRUGPlacebo
Placebo 4 mL/vial. Subcutaneous injection 4 or 8 mL. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses.
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactQian Jia
Outcome results
None listed