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NOT YET RECRUITING
NCT06791772
PHASE2

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

Sponsor: Keymed Biosciences Co.Ltd

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-02

Completion Date

2027-02

Last Updated

2025-01-24

Healthy Volunteers

No

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.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China