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NCT07647510

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

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
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Record History

All 8 versions: 8 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 4 → 12 locations
    • Study sites revised (12)
  2. Study sites: 4 to 12
  3. Eligibility criteria expanded, about 25 words
    • Study sites: 3 to 4
    • Secondary endpoints: details revised at 2 of 10 entries
    • Study description expanded, about 4 words
  4. Site details revised at 1 of 3 sitesv5
  5. Study sites: 2 to 3v4
  6. Study sites: 1 to 2
    • Start date changed from estimate of Jul 2026 to Jun 29, 2026
    v3
  7. Recruitment opened
    • Study sites: 0 to 1
    v2
  8. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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

Secondary (10)

Change from Baseline to Week 17 in Quantitative Myasthenia Gravis (QMG) Scale Score
Change from Baseline to Week 17 in Myasthenia Gravis Composite (MGC) Scale Score
Proportion of Participants with Greater Than or Equal to (≥) a 5-point Reduction in MG-ADL Scale Score at Week 17 Compared to Baseline
Proportion of Participants Who Reach Minimal Symptom Expression (MSE), Defined as MG-ADL 0 or 1 at Week 17, Without Use of Rescue Therapy
Proportion of Participants with a ≥ 5-point Reduction in QMG Scale Score at Week 17 Compared to Baseline
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Incidence of Treatment-emergent Adverse Events (TEAEs) and Treatment-Emergent and Treatment-Emergent Serious Adverse Events (SAEs) in the RCT period, BEP, OLE, and Safety Follow-Up
Serum Concentrations of Claseprubart
Change from Baseline in Complement Total Blood Test (CH50) in Serum ex vivo
Incidence of Antidrug Antibody (ADAs) Against Claseprubart in the RCT Period, BEP, OLE, and Safety Follow-Up
Titer of ADAs Against Claseprubart in the RCT Period, BEP, OLE, and Safety Follow-Up

Arms and interventions

PlaceboPlacebo comparator

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).

Claseprubart Q2WExperimental

IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart Q2W starting at Week 1 (Day 8).

Claseprubart Every 4 weeks (Q4W)Experimental

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.

Drugs: Claseprubart, Placebo

Combination products: Claseprubart, Placebo

Sites

12 sites in 3 countries

Georgia 6, United States 4, Ukraine 2