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Study of CM313(SC) Injection in Systemic Lupus Erythematosus(SLE)
Sponsor: Keymed Biosciences Co.Ltd
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
Conditions
Interventions
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.
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.
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