Phase 3 MIL62 treatment for systemic lupus erythematosus

A Phase 3 Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Systemic Lupus Erythematosus.

This study will test whether MIL62 is more effective and safe than placebo for adults with active systemic lupus erythematosus.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 316 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Mabworks Biotech Co., Ltd. (industry)
• Drugs / interventions: rituximab, Belimumab, cyclophosphamide
• Locations: 1 site (Beijing)
• Trial ID: NCT07405970 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial compares MIL62 with placebo in adults who meet EULAR/ACR criteria for SLE and have high disease activity. Eligible participants must have positive ANA or anti-dsDNA and be on a stable dose of standard SLE treatments before dosing. Enrolled adults will receive MIL62 or placebo and be followed for measures of disease activity and safety over the treatment period. The study is designed to determine whether MIL62 reduces SLE disease activity and has an acceptable safety profile compared with placebo.

Who should consider this trial

Good fit: Adults 18–80 years old with SLE by EULAR/ACR criteria, positive ANA (≥1:80) or anti-dsDNA, a SLEDAI-2000 score ≥8, and on stable standard SLE therapy are ideal candidates.

Not a fit: Patients with significant organ dysfunction, CD4+ counts below 200 cells/µL, recent B‑cell‑depleting therapy, recent cyclophosphamide, calcineurin inhibitors, or recent plasma exchange are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, MIL62 could provide a new treatment option that reduces disease activity and improves symptoms for people with active SLE.

How similar studies have performed: Other B‑cell–targeting therapies have benefitted some SLE patients, but MIL62 is a novel agent now undergoing phase 3 testing.

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. High disease activity at screening ,SLEDAI-2000 score ≥8 (excluding alopecia score);
5. On a stable dose of one or more standard treatments for SLE prior to the first administration；
6. Able and willing to provide written informed consent and to comply with the study protocol.

Exclusion Criteria:

1. Unsufficient organ function;
2. Received rituximab or any B-cell depleting drug within 9 months prior to the first dose;
3. Subjects with CD4+ T lymphocyte count \< 200 cells/μL;
4. Received cyclophosphamide within 8 weeks prior to the first dose; received calcineurin inhibitors (cyclosporine, tacrolimus, etc., except for topical use) or plasma exchange therapy within 4 weeks prior to the first dose;
5. Received a B-cell stimulating factor inhibitor such as Belimumab, and Telitacicept within 8 weeks prior to the first administration;
6. TNF inhibitor, interleukin monoclonal antibody, JAK inhibitor, BTK inhibitor, TYK2 inhibitor, or thalidomide within 4 weeks prior to the first administration;
7. Received live or attenuated vaccination within 28 days prior to the first administration;
8. Participated in other clinical trials within 28 days prior to the first administration;
9. Concomitant with other serious diseases;
10. Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with HBV DNA titer above the normal range; positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV);
11. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies MIL62;
12. Breastfeeding or pregnant women;
13. Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method;
14. 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

Conditions: Systemic Lupus Erythematosus