NCT07405970 A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus
| NCT ID | NCT07405970 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Beijing Mabworks Biotech Co., Ltd. |
| Condition | Systemic Lupus Erythematosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 316 participants |
| Start Date | 2026-04-10 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 316 participants in total. It began in 2026-04-10 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the efficacy and safety of MIL62 compared with placebo in participants with systemic lupus erythematosus.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07405970 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07405970 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 316 participants.
Is NCT07405970 currently recruiting?
Yes, NCT07405970 is actively recruiting participants. Contact the research team at Zgli@aliyun.com for enrollment information.
Where is the NCT07405970 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07405970 clinical trial?
NCT07405970 is sponsored by Beijing Mabworks Biotech Co., Ltd.. The trial plans to enroll 316 participants.
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