A Clinical Study of MIL62 in Systemic Lupus Erythematosus

Phase 2

Recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: MIL62; Drug: placebo

• Registration Number: NCT05796206
• Lead Sponsor: Beijing Mabworks Biotech Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-04-03
• Study Start: 2023-05-26
• Status Verified: 2023-12
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13
• Primary Completion: 2026-02
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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. Low C3 and/or low C4 complement at screening ;
5. High disease activity at screening ;
6. On a stable SLE treatment regimen for at least 30 days prior to the first administration；
7. Able and willing to provide written informed consent and to comply with the study protocol.

Exclusion Criteria

1. Unsufficient organ function;
2. Have received treatment with B cell targeted therapy within 9 months prior to the first administration;
3. Subjects with CD4+ T lymphocyte count < 200 cells/μL;
4. Receipt of any of the following prior to the first administration: Cyclophosphamide,Calcineurin inhibitor, blood transfusion ;
5. Received TNF inhibitor, Beliumumab, and Tetasercept within 3 months prior to the first administration; Interleukin monoclonal antibody, JAK inhibitor, BTK inhibitor within 2 months prior to the first administration;
6. Received live or attenuated vaccination within 28 days prior to the first administration;
7. Participated in other clinical trials within 28 days prior to the first administration;
8. Concomitant with other serious diseases；
9. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C;
10. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies，MIL62；
11. Breastfeeding or pregnant women;
12. Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method;
13. Other conditions unsuitable for participation in this study determined by the Investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIL62(Part A and B)	MIL62	-
Placebo (Part A and B)	placebo	-

Primary Outcome Measures

Name	Time	Method
Part A and Part B:Percentage of participants achieving SRI-4 at Week 52	Week 52

Secondary Outcome Measures

Name	Time	Method
Part A and Part B:Proportion of participants achieving SRI-4 at Week 76	Week 76
Part A and Part B:Percent of patients achieving The British Isles Lupus Assessment Group (BILAG)	Week 52
Part A and Part B:Proportion of participants achieving SRI-4 at Week 24.	Week 24
Part A and Part B:Change From Baseline in EuroQol- 5 Dimension (EQ-5D) at Week 52	Baseline and Week 76
Part A and Part B:Change From Baseline in Serum Immunoglobulin Levels at Week 24	Baseline and Week 76	Change from baseline in the serum levels of IgG, IgA, IgM
Part A and Part B:Change From Baseline in biomarkers associated with disease anti-dsDNA ,complement component 3 (C3), and complement component 4 (C4)	Baseline and Week 76
Part A and Part B:Percentage of Participants with Adverse Events	From baseline to Week 76
Part A and Part B:Pharmacokinetic(PK) Parameters: AUC	up to Week76Day7 after enrollment	The area under the curve (AUC) of serum concentration of the drug after the administration
Part A and Part B:Pharmacokinetic(PK) Parameters:Cmax	up to Week76Day7 after enrollment	Maximum concentration(Cmax) of the drug after administration
Part A and Part B:Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of MIL62	up to Week76Day7 after enrollment

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China