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NCT06607627

PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

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Record History

All 14 versions: 13 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 13 sitesv14
  2. Site details revised at 3 of 13 sitesv13
  3. Study sites: 12 to 13
    • Primary completion date: Apr 16, 2027 to Dec 15, 2026
    • Study completion date: Jul 18, 2029 to Jan 23, 2029
    v12
  4. Site details revised at 3 of 12 sitesv10
  5. Site details revised at 2 of 12 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Start date: Dec 23, 2024 to Nov 13, 2024
    • Site details revised at 1 of 12 sites
    v8
  2. Start date: Nov 13, 2024 to Dec 23, 2024
    • Site details revised at 2 of 12 sites
    v7
  3. Start date: Dec 23, 2024 to Nov 13, 2024
    • Site details revised at 1 of 12 sites
    v6
  4. Start date: Nov 13, 2024 to Dec 23, 2024
    • Study sites: 11 to 12
    v5
  5. Study sites: 12 to 11
    • Primary completion date: Jul 30, 2027 to Apr 16, 2027
    • Study completion date: Jun 12, 2029 to Jul 18, 2029
    v4
  6. Eligibility criteria expanded, about 69 words
    • Study completion date: Oct 1, 2029 to Jun 12, 2029
    • Site details revised at 1 of 12 sites
    v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Apr 2, 2027 to Jul 30, 2027
    • Start date changed from estimate of Mar 4, 2025 to Nov 13, 2024
    • Site details revised at 12 of 12 sites
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Maximum Observed Serum Concentration (Cmax) of Gefurulimab
Timeframe: Day 1 predose through Week 18 predose
Serum Free Complement Component 5 (C5) Concentration
Timeframe: Day 1 predose through Week 18 predose

Secondary (8)

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Change in Quantitative Myasthenia Gravis Score for Disease Severity (QMG) Total Score From Baseline Through Week 18
Number of Participants With ≥ 5-point Reduction From Baseline in the QMG Total Score Through Week 18
Change in Myasthenia Gravis Activities of Daily Living Profile (MG-ADL) Total Score From Baseline Through Week 18
Number of Participants With ≥ 3-point Reduction From Baseline in the MG-ADL Total Score Through Week 18
Show 3 moreShow less
Number of Participants With Anti-drug Antibodies (ADAs)
Number of ADA Positive Participants With Pre-existing Immunoreactivity,Treatment-emergent or Treatment-boosted ADA Responses
Number of ADA Positive Participants With Neutralizing Antibody (NAb) Positive or Negative Status

Arms and interventions

GefurulimabExperimental

On Day 1, participants will receive a weight based loading dose followed by a weekly maintenance dose for up to 122 weeks.

Combination products: Gefurulimab

Sites

13 sites in 5 countries

Brazil 5, Poland 3, Taiwan 2, United States 2, Japan 1