Study of CM313(SC) Injection in Systemic Lupus Erythematosus(SLE)
ConditionSystemic Lupus Erythematosus
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKeymed Biosciences Co.Ltd
About this trial
To evaluate the efficacy and safety of CM313(SC) injection in systemic lupus erythematosus(SLE)
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CM313 injection
- CM313 injection
- Placebo
Treatment groups
150 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov