Clinical trial NCT05796206: A Clinical Study of MIL62 in Systemic Lupus Erythematosus
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Beijing Mabworks Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Part A and Part B:Percentage of participants achieving SRI-4 at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Part A and Part B:Proportion of participants achieving SRI-4 at Week 76
timeFrame: Week 76
measure: Part A and Part B:Percent of patients achieving The British Isles Lupus Assessment Group (BILAG)
timeFrame: Week 52
measure: Part A and Part B:Proportion of participants achieving SRI-4 at Week 24.
timeFrame: Week 24
measure: Part A and Part B:Change From Baseline in EuroQol- 5 Dimension (EQ-5D) at Week 52
timeFrame: Baseline and Week 76
measure: Part A and Part B:Change From Baseline in Serum Immunoglobulin Levels at Week 24
timeFrame: Baseline and Week 76
measure: Part A and Part B:Change From Baseline in biomarkers associated with disease anti-dsDNA ,complement component 3 (C3), and complement component 4 (C4)
timeFrame: Baseline and Week 76
measure: Part A and Part B:Percentage of Participants with Adverse Events
timeFrame: From baseline to Week 76
measure: Part A and Part B:Pharmacokinetic(PK) Parameters: AUC
timeFrame: up to Week76Day7 after enrollment
measure: Part A and Part B:Pharmacokinetic(PK) Parameters:Cmax
timeFrame: up to Week76Day7 after enrollment
measure: 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
timeFrame: up to Week76Day7 after enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
References: