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.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Contact Information
Primary
Zhanguo Li, Doctor
Zgli@aliyun.com
(+86)010 -88324172
Time Frame
Start Date: 2023-05-26
Estimated Completion Date: 2026-07
Participants
Target number of participants: 200
Treatments
Experimental: MIL62(Part A and B)
Placebo_comparator: Placebo (Part A and B)
Related Therapeutic Areas
Sponsors
Leads: Beijing Mabworks Biotech Co., Ltd.