A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus

NCT07405970 | Recruiting Phase 3

• 1 other identifier: MIL62-CT309
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy and safety of MIL62 compared with placebo in participants with systemic lupus erythematosus.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Percentage of participants achieving SRI-4 at Week 52

  at Week 52

Secondary Outcomes (9)

• 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 EuroQol 5-Dimensional Questionnaire at Week 24, 52

  up to 52 weeks 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

Other Outcomes (1)

• Percentage of participants achieving Lupus Low Disease Activity State (LLDAS) at Week 52

  at Week 52

Study Arms (2)

MIL62

EXPERIMENTAL

Drug: MIL62

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MIL62 DRUG

MIL62 will be administered by intravenous (IV) infusion at a dose of 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1.

MIL62

Placebo DRUG

Placebo will be administered by intravenous (IV) infusion at a dose of 1000 mg on W1D1, W3D1, W25D1, W27D1.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 ;
• Diagnosis of systemic lupus erythematosus according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria ;
• Positive antinuclear antibodies (ANA) ≥ 1:80 at screening or positive anti- dsDNA ;
• High disease activity at screening ,SLEDAI-2000 score ≥8 (excluding alopecia score);
• On a stable dose of one or more standard treatments for SLE prior to the first administration；
• Able and willing to provide written informed consent and to comply with the study protocol.

You may not qualify if:

• Unsufficient organ function;
• Received rituximab or any B-cell depleting drug within 9 months prior to the first dose;
• Subjects with CD4+ T lymphocyte count \< 200 cells/μL;
• 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;
• Received a B-cell stimulating factor inhibitor such as Belimumab, and Telitacicept within 8 weeks prior to the first administration;
• TNF inhibitor, interleukin monoclonal antibody, JAK inhibitor, BTK inhibitor, TYK2 inhibitor, or thalidomide within 4 weeks prior to the first administration;
• Received live or attenuated vaccination within 28 days prior to the first administration;
• Participated in other clinical trials within 28 days prior to the first administration;
• Concomitant with other serious diseases;
• 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);
• Subjects with known history of severe allergic reactions to humanized monoclonal antibodies MIL62;
• Breastfeeding or pregnant women;
• Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method;
• Other conditions unsuitable for participation in this study determined by the Investigator.

Sponsors & Collaborators

• Beijing Mabworks Biotech Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Zhanguo Li

CONTACT

8610-88324172; Zgli@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-02

Locations

CN (1)