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New treatment option for Systemic Lupus Erythematosus
Official title A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT07405970
What this study is testing
What is MIL62?
MIL62 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the efficacy and safety of MIL62 compared with placebo in participants with systemic lupus erythematosus.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age 18-80 ;
- Diagnosis of systemic lupus erythematosus according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE...
- Positive antinuclear antibodies (ANA) ≥ 1:80 at screening or positive anti- dsDNA ;
- High disease activity at screening ,SLEDAI-2000 score ≥8 (excluding alopecia score);
- On a stable dose of one or more standard treatments for SLE prior to the first administration；
You likely can't join if
- Unsufficient organ function;
- Received rituximab or any B-cell depleting drug within 9 months prior to the first dose;
- people with CD4+ T lymphocyte count \< 200 cells/μL;
- Received cyclophosphamide within 8 weeks prior to the first dose; received calcineurin inhibitors (cyclosporine, tacrolimus, etc., except for topical...
- Received a B-cell stimulating factor inhibitor such as Belimumab, and Telitacicept within 8 weeks prior to the first administration;
- TNF inhibitor, interleukin monoclonal antibody, JAK inhibitor, BTK inhibitor, TYK2 inhibitor, or thalidomide within 4 weeks prior to the first...
See the full eligibility criteria
- 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 ;
- High disease activity at screening ,SLEDAI-2000 score ≥8 (excluding alopecia score);
- On a stable dose of one or more standard treatments for SLE prior to the first administration；
- Able and willing to provide written informed consent and to comply with the study protocol.
- Unsufficient organ function;
- Received rituximab or any B-cell depleting drug within 9 months prior to the first dose;
- people with CD4+ T lymphocyte count \< 200 cells/μL;
- Received cyclophosphamide within 8 weeks prior to the first dose; received calcineurin inhibitors (cyclosporine, tacrolimus, etc., except for topical use) or plasma exchange therapy within 4 weeks prior to the first...
- Received a B-cell stimulating factor inhibitor such as Belimumab, and Telitacicept within 8 weeks prior to the first administration;
- TNF inhibitor, interleukin monoclonal antibody, JAK inhibitor, BTK inhibitor, TYK2 inhibitor, or thalidomide within 4 weeks prior to the first administration;
- Received live or attenuated vaccination within 28 days prior to the first administration;
- Participated in other clinical trials within 28 days prior to the first administration;
- Concomitant with other serious diseases;
- Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with HBV DNA titer above the normal range; positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency...
- people with known history of severe allergic reactions to humanized monoclonal antibodies MIL62;
- Breastfeeding or pregnant women;
- Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method;
- Other conditions unsuitable for participation in this study determined by the Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.