A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE)

Part of paid clinical trials in Fayetteville, North Carolina.

Sponsor
Dianthus Therapeutics
Study ID
NCT07647510
Phase
PHASE3
Status
Recruiting
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Conditions

  • Myasthenia Gravis, Generalized

Eligibility Criteria

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

Interventions

  • Claseprubart — DRUG
    IV loading dose on Day 1
  • Placebo — DRUG
    IV infusion on Day 1
  • Claseprubart — COMBINATION_PRODUCT
    Prefilled syringe containing claseprubart for SC administration
  • Placebo — COMBINATION_PRODUCT
    Prefilled syringe containing placebo for SC administration

Study Details

The purpose of this Phase 3 study is to demonstrate the efficacy, safety, and tolerability of claseprubart in participants with generalized myasthenia gravis (gMG).

Key Dates

First listed
Jun 15, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Sep 30, 2031

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Intravenous (IV) infusion of Placebo on Day 1 followed by subcutaneous (SC) injections of Placebo every 2 weeks (Q2W) starting at Week 1 (Day 8).
  • Experimental: Claseprubart Q2W
    IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart Q2W starting at Week 1 (Day 8).
  • Experimental: Claseprubart Every 4 weeks (Q4W)
    IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart or Placebo Q2W starting at Week 1 (Day 8), with doses alternating between claseprubart and placebo.

Primary Outcome Measure

Change from Baseline to Week 17 in Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale Score [ Time Frame: Baseline (Day 1) to Week 17 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cinical Study SiteFayettevilleNorth Carolina28304-

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Cinical Study Site· Fayetteville, NC

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