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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

CM313 injection
Biological/Vaccine
CM313 600mg（4ml）/vial. Subcutaneous injection 600mg. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses.
CM313 injection
Biological/Vaccine
CM313 600mg（4ml）/vial. Subcutaneous injection 1200mg. The first 5 doses were administered weekly, followed by every two weeks, a total of 14 doses.
Placebo
Drug
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.

Treatment groups

150 Participants

are divided into 3 treatment groups

Group A: Group AExperimental treatment 1 intervention

Group B: Group BExperimental treatment 1 intervention

Group C: Group CPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index -4 (SRI-4)

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

Time frame

Up to week 24

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Keymed Biosciences Co.Ltd

Lead sponsor

Source ClinicalTrials.gov

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