A Phase 2 Clinical Study of MIL62 in Systemic Lupus Erythematosus

NCT05796206 | Active Not Recruiting Phase 2

• 1 other identifier: MIL62-CT308
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy, safety, pharmacokinetics(PK), pharmacodynamics(PD) and ADA of MIL62 compared with placebo in participants with systemic lupus erythematosus.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Part A and Part B:Percentage of participants achieving SRI-4 at Week 12

  at Week 12

Secondary Outcomes (13)

• Part A and Part B:Proportion of participants achieving SRI-4 at Week 52

  at Week 52

• Part A and Part B:Proportion of participants achieving SRI-4 at Week 24

  at Week 24

• Part A and Part B:Proportion of participants achieving SRI-4 at Week76

  at Week 76

• Part A and Part B:Change From Baseline in 24-hour urine protein in participants with elevated baseline urine protein (24-hour urine protein ≥ 0.5g) at Week 24,52,76

  up to 76 weeks after randomization

• Part A and Part B: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

Study Arms (2)

MIL62(Part A and B)

EXPERIMENTAL

Drug: MIL62

Placebo (Part A and B)

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, W53D1, and W55D1.

MIL62(Part A and B)

placebo DRUG

Placebo will be administered by intravenous (IV) infusion at a dose of 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1, W53D1, and W55D1.

Placebo (Part A and B)

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 ;
• Low C3 and/or low C4 complement at screening ;
• High disease activity at screening ;
• On a stable SLE treatment regimen for at least 30 days 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 12 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

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 3, 2023
• Study Start: May 26, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

CN (1)