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NCT06607627 · ClinicalTrials.gov registry record · Phase 3
PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis
A Phase 3 study of Generalized Myasthenia Gravis and gMG, sponsored by Alexion Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 12
- Enrollment target
- 13
- Study locations
NCT06607627 is a Phase 3 study of Generalized Myasthenia Gravis and gMG that is actively recruiting participants, run by Alexion Pharmaceuticals. The registered enrollment target is 12 participants, below the 131-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (91% lower). The trial reports 13 study locations across 3 states.
The verdict
NCT06607627, a Phase 3 study of Generalized Myasthenia Gravis and gMG, is actively recruiting participants, sponsored by Alexion Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 12 participants
- Enrollment target
- 13
- Study locations
Study Summary
The primary objective of this study is to assess the pharmacokinetics and pharmacodynamics of gefurulimab in pediatric participants with AChR+ gMG for the duration of the study.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Gefurulimab
Study Locations (13)
Other
- Research Site - Joinville
- Research Site - Salvador
- Research Site - São José do Rio Preto
- Research Site - São Paulo
- Research Site - São Paulo
- Research Site - Saitama-Shi
- Research Site - Bydgoszcz
- Research Site - Lodz
- Research Site - Warsaw
- Research Site - New Taipei City
- Research Site - Taipei
District of Columbia
- Research Site - Washington D.C.
Virginia
- Research Site - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-11-13 |
| Est. Completion | 2029-01-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06607627
The ClinicalTrials.gov registry entry for NCT06607627 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 131-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (91% lower). The listed sponsor is Alexion Pharmaceuticals, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Generalized Myasthenia Gravis appearing as the primary indexed condition, and to 1 intervention - of which Gefurulimab is the first listed.
NCT06607627 reports 13 study locations spanning 3 distinct geographic areas - top geographies include Other, District of Columbia, Virginia.
Frequently Asked Questions
What is clinical trial NCT06607627 about?
NCT06607627 is a clinical study titled "PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis". The primary objective of this study is to assess the pharmacokinetics and pharmacodynamics of gefurulimab in pediatric participants with AChR+ gMG for the duration of the study.
What is the current status of trial NCT06607627?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 12 participants. The study started on 2024-11-13. Estimated completion is 2029-01-23.
What conditions does trial NCT06607627 study?
This clinical trial studies the following conditions: Generalized Myasthenia Gravis, gMG.
What interventions are being tested in trial NCT06607627?
The interventions under investigation include: Gefurulimab (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06607627?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06607627 being conducted?
This trial has 13 study locations across District of Columbia, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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