NCT06791772

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-10-01
• Completion: 2027-02-01
• First posted: 2025-01-24
• Last updated: 2025-01-24

Locations

1 site across 1 country: China