A Clinical Study of MIL62 in Systemic Lupus Erythematosus

Launched by BEIJING MABWORKS BIOTECH CO., LTD. · Mar 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called MIL62 for people with a condition known as systemic lupus erythematosus (SLE), which is an autoimmune disease that can affect various parts of the body. The purpose of the study is to see how effective and safe MIL62 is compared to a placebo (a dummy treatment) in helping manage SLE symptoms. Researchers will also look at how the body processes MIL62 and any immune responses it might trigger.

To participate in this trial, individuals must be between 18 and 80 years old and have a confirmed diagnosis of SLE. They should also have certain lab findings indicating active disease, such as specific antibodies and low complement levels, and must have been on a stable treatment plan for at least 30 days prior to starting the study. Participants will be monitored closely to assess the treatment's effects and safety. It’s important to note that some individuals, such as those with certain serious health conditions or specific recent treatments, may not be eligible to join. If you are interested in participating, you'll need to provide written consent and agree to follow the study guidelines.

Gender

ALL

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.