A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus
ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Mabworks Biotech Co., Ltd.
About this trial
This study will evaluate the efficacy and safety of MIL62 compared with placebo in participants with systemic lupus erythematosus.
Eligibility criteria
Qualifiers
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);
Disqualifiers
Unsufficient organ function;
Received rituximab or any B-cell depleting drug within 9 months prior to the first dose;
Subjects 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 dose;
Trial design
Treatments tested in this trial
- MIL62
- Placebo
Treatment groups
316 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov