Evaluating MIL62 for treating systemic lupus erythematosus

A Phase Ⅱ/Ⅲ Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Systemic Lupus Erythematosus.

This study is testing a new treatment called MIL62 to see if it can help people with lupus feel better compared to a placebo.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Mabworks Biotech Co., Ltd. (industry)
• Drugs / interventions: Beliumumab, Cyclophosphamide
• Locations: 1 site (Beijing)
• Trial ID: NCT05796206 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the efficacy and safety of MIL62 compared to a placebo in patients diagnosed with systemic lupus erythematosus. The study will also evaluate the pharmacokinetics and pharmacodynamics of MIL62, along with the presence of anti-drug antibodies. Participants will be monitored for their disease activity and overall response to the treatment over the course of the trial. The study is designed for individuals aged 18 to 80 who meet specific diagnostic criteria for lupus.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-80 with a confirmed diagnosis of systemic lupus erythematosus and high disease activity.

Not a fit: Patients with insufficient organ function or those who have recently received certain immunosuppressive therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from systemic lupus erythematosus.

How similar studies have performed: While there have been studies on treatments for systemic lupus erythematosus, the specific approach with MIL62 is novel and has not been extensively tested.

Eligibility 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.

Where this trial is running

Beijing

• Peking University People's Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Zhanguo Li, Doctor

Conditions: Systemic Lupus Erythematosus