A Clinical Study of MIL62 in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Phase Ⅱ/Ⅲ Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Systemic Lupus Erythematosus.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05796206
• Other study ID #: MIL62-CT308
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 26, 2023
• Est. completion date: July 2026

Study information

• Verified date: December 2023
• Source: Beijing Mabworks Biotech Co., Ltd.
• Contact: Zhanguo Li, Doctor
• Phone: (+86)010 -88324172
• Email: Zgli[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• MIL62
An intravenous (IV) infusion of 1000 mg of MIL62 will be administered at W1D1?W3D1?W25D1?W27D1?W53D1?W55D1.
• placebo
An intravenous (IV) infusion of placebo will be administered at W1D1?W3D1?W25D1?W27D1?W53D1?W55D1.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Mabworks Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A and Part B:Percentage of participants achieving SRI-4 at Week 52		Week 52
Secondary	Part A and Part B:Proportion of participants achieving SRI-4 at Week 76		Week 76
Secondary	Part A and Part B:Percent of patients achieving The British Isles Lupus Assessment Group (BILAG)		Week 52
Secondary	Part A and Part B:Proportion of participants achieving SRI-4 at Week 24.		Week 24
Secondary	Part A and Part B:Change From Baseline in EuroQol- 5 Dimension (EQ-5D) at Week 52		Baseline and Week 76
Secondary	Part A and Part B:Change From Baseline in Serum Immunoglobulin Levels at Week 24	Change from baseline in the serum levels of IgG, IgA, IgM	Baseline and Week 76
Secondary	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
Secondary	Part A and Part B:Percentage of Participants with Adverse Events		From baseline to Week 76
Secondary	Part A and Part B:Pharmacokinetic(PK) Parameters: AUC	The area under the curve (AUC) of serum concentration of the drug after the administration	up to Week76Day7 after enrollment
Secondary	Part A and Part B:Pharmacokinetic(PK) Parameters:Cmax	Maximum concentration(Cmax) of the drug after administration	up to Week76Day7 after enrollment
Secondary	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