A Clinical Study of MIL62 in Systemic Lupus Erythematosus

• Status: Not yet recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, safety, pharmacokinetics(PK) 、pharmacodynamics(PD) and ADA of MIL62 compared with placebo in participants with systemic lupus erythematosus.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Mabworks Biotech Co., Ltd.

Criteria

Inclusion Criteria:

1. Age 18-80 ;

2. Diagnosis of systemic lupus erythematosus according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria ;

3. Positive antinuclear antibodies (ANA) ≥ 1:80 at screening or positive anti- dsDNA ;

4. Low C3 and/or low C4 complement at screening ;

5. High disease activity at screening ;

6. On a stable SLE treatment regimen for at least 30 days prior to the first administration；

7. Able and willing to provide written informed consent and to comply with the study protocol.

Exclusion Criteria:

1. Unsufficient organ function;

2. Have received treatment with B cell targeted therapy within 9 months prior to the first administration;

3. Subjects with CD4+ T lymphocyte count < 200 cells/μL;

4. Receipt of any of the following prior to the first administration:

Cyclophosphamide,Calcineurin inhibitor, blood transfusion ;

5. Received TNF inhibitor, Beliumumab, and Tetasercept within 3 months prior to the first administration; Interleukin monoclonal antibody, JAK inhibitor, BTK inhibitor within 2 months prior to the first administration;

6. Received live or attenuated vaccination within 28 days prior to the first administration;

7. Participated in other clinical trials within 28 days prior to the first administration;

8. Concomitant with other serious diseases；

9. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C;

10. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies，MIL62；

11. Breastfeeding or pregnant women;

12. Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method;

13. Other conditions unsuitable for participation in this study determined by the Investigator.