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

NCT06791772 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-01-24

No results posted yet for this study

Summary

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

Conditions

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.

Sponsors & Collaborators

  • Keymed Biosciences Co.Ltd

    lead INDUSTRY

Principal Investigators

  • Xiaofeng Zeng · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2026-10-31
Completion
2027-02-28

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06791772 on ClinicalTrials.gov