Not yet recruiting NCT06791772
Study of CM313(SC) Injection in Systemic Lupus Erythematosus(SLE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CM313 injection, CM313 injection, Placebo.
- Who it may be relevant to
- Registry conditions: Systemic Lupus Erythematosus. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
To evaluate the efficacy and safety of CM313(SC) injection in systemic lupus erythematosus(SLE)
Interventions
- Biological CM313 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. - Biological CM313 injection
CM313 600mg（4ml）/vial. Subcutaneous injection 1200mg. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses. - Drug Placebo
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.
Primary outcome measures
- Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4) [Time frame: Up to week 24]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT06791772 · CM313-106106