Phase 3 MIL62 treatment for systemic lupus erythematosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University People's Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Zhanguo Li
• Email: Zgli@aliyun.com
• Phone: 8610-88324172

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.