A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus

Sponsor
Beijing Mabworks Biotech Co., Ltd.
Study ID
NCT07405970
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

This study will evaluate the efficacy and safety of MIL62 compared with placebo in participants with systemic lupus erythematosus.

Key Dates

First listed
Feb 12, 2026
Start date
Apr 10, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
316 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MIL62
  • Placebo Comparator: Placebo

Primary Outcome Measure

Percentage of participants achieving SRI-4 at Week 52 [ Time Frame: at Week 52 ]

Central Contacts

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