Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • MIL62

    Drug

    MIL62 will be administered by intravenous (IV) infusion at a dose of 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1.

  • Placebo

    Drug

    Placebo will be administered by intravenous (IV) infusion at a dose of 1000 mg on W1D1, W3D1, W25D1, W27D1.

Treatment groups

316 Participants
are divided into 2 treatment groups
Group A: MIL62Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of participants achieving SRI-4 at Week 52

Time frame
at Week 52

Secondary outcomes

1

Proportion of participants achieving SRI-4 at Week 24

Time frame
at Week 24
2

Changes in 24-hour urine protein in patients with baseline 24-hour urine protein elevation (24-hour urine protein ≥0.5g) at Week 24, 52

Time frame
at Week 24,52
3

Percentage of participants who achieved or maintained a prednisone dose of ≤7.5 mg/day (or equivalent dose) during Weeks 40 to 52

Time frame
from Week 40 to Week 52 after randomization
4

Change From Baseline in EuroQol 5-Dimensional Questionnaire at Week 24, 52

EuroQol 5-Dimensional Questionnaire，the scale ranges from a minimum of 0 to a maximum of 100, where 100 represents the best imaginable health state and 0 represents the worst imaginable.

Time frame
up to 52 weeks after randomization

Other outcomes

1

Percentage of participants achieving Lupus Low Disease Activity State (LLDAS) at Week 52

Time frame
at Week 52

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Mabworks Biotech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now