A Phase 3 Clinical Study of MIL62 in 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 evaluate the efficacy and safety of MIL62 compared with placebo in participants with systemic lupus erythematosus.

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: MIL62; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 316
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zhanguo Li; Phone Number: 8610-88324172; Email: Zgli@aliyun.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University People's Hospital
    • Contact: Zhanguo Li, Doctor; Phone Number: 8610-88324172; Email: Zgli@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo will be administered by intravenous (IV) infusion at a dose of 1000 mg on W1D1, W3D1, W25D1, W27D1.
Experimental: MIL62	Drug: MIL62; MIL62 will be administered by intravenous (IV) infusion at a dose of 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants achieving SRI-4 at Week 52	at Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving SRI-4 at Week 24		at Week 24
Changes in 24-hour urine protein in patients with baseline 24-hour urine protein elevation (24-hour urine protein ≥0.5g) at Week 24, 52		at Week 24,52
Percentage of participants who achieved or maintained a prednisone dose of ≤7.5 mg/day (or equivalent dose) during Weeks 40 to 52		from Week 40 to Week 52 after randomization
Change From Baseline in Serum Immunoglobulin Levels at Week 24 Change from baseline in the serum levels of IgG, IgA, IgM		up to 52 weeks after randomization
Change From Baseline in biomarkers associated with disease anti-dsDNA ,complement component 3 (C3), and complement component 4 (C4)		up to 52 weeks after randomization
Percentage of Participants with Adverse Events		up to 52 weeks after randomization
Pharmacodynamics(PD) characteristics: summarizing the changes in the absolute counts and percentages of peripheral blood CD19⁺ B cells		up to 52 weeks after randomization
Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of MIL62		up to 52 weeks after randomization
Change From Baseline in EuroQol 5-Dimensional Questionnaire at Week 24, 52	EuroQol 5-Dimensional Questionnaire，the scale ranges from a minimum of 0 to a maximum of 100, where 100 represents the best imaginable health state and 0 represents the worst imaginable.	up to 52 weeks after randomization

Other Outcome Measures

Outcome Measure	Time Frame
Percentage of participants achieving Lupus Low Disease Activity State (LLDAS) at Week 52	at Week 52

Collaborators and Investigators

• Sponsor: Beijing Mabworks Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: MIL62-CT309

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No