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NCT02965573 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
A Phase 2 study of Myasthenia Gravis, sponsored by argenx.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 19
- Study locations
NCT02965573: Completed Phase 2 study of Myasthenia Gravis, sponsored by argenx.
NCT02965573 is a Phase 2 study of Myasthenia Gravis that has completed, run by argenx. The registered enrollment target is 24 participants, below the 190-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (87% lower). The trial reports 19 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02965573, a Phase 2 study of Myasthenia Gravis, has completed, sponsored by argenx.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 19
- Study locations
Study Summary
This is a randomized, double-blind, placebo-controlled, multicenter Phase II study to evaluate the safety, efficacy, and pharmacokinetics of ARGX-113 for the treatment of autoimmune Myasthenia Gravis (MG) with generalized muscle weakness.
Primary Outcome
TEAEs were defined as AEs that first occurred or worsened in severity after the first administration of the treatment. A treatment emergent SAE was any untoward medical occurrence that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent or significant disability or incapacity; was a congenital abnormality or birth defect; or other medically significant events. All TEAEs observed were graded using the Natio
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL ARGX-113
Study Locations (19)
Other
- Investigator Site 2 - Ghent
- Investigator Site 1 - Leuven
- Investigator Site 4 - Montreal
- Investigator Site 3 - Toronto
- Investigator Site 7 - Bergamo
- Investigator Site 6 - Milan
- Investigator Site 5 - Roma
- Investigator Site 8 - Leiden
- Investigator Site 10 - Gdansk
- Investigator Site 9 - Krakow
- Investigator Site 12 - Barcelona
- Investigator Site 11 - Madrid
- Investigator Site 13 - Solna
California
- Investigator Site 19 - Irvine
- Investigator Site 17 - Los Angeles
Florida
- Investigator Site 15 - Tampa
Indiana
- Investigator Site 16 - Indianapolis
North Carolina
- Investigator Site 14 - Chapel Hill
Ohio
- Investigator Site 18 - Dublin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-12-30 |
| Est. Completion | 2017-10-20 |
| Phase | Phase 2 |
What the finished NCT02965573 record still lists
NCT02965573 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 190-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Myasthenia Gravis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02965573 lists 19 locations in 6 states (Other, California, Florida).
Frequently Asked Questions
What is clinical trial NCT02965573 about?
NCT02965573 is a clinical study titled "A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness". This is a randomized, double-blind, placebo-controlled, multicenter Phase II study to evaluate the safety, efficacy, and pharmacokinetics of ARGX-113 for the treatment of autoimmune Myasthenia Gravis (MG) with generalized muscle weakness.
What is the current status of trial NCT02965573?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2016-12-30. Estimated completion is 2017-10-20.
What conditions does trial NCT02965573 study?
This clinical trial studies the following conditions: Myasthenia Gravis.
What interventions are being tested in trial NCT02965573?
The interventions under investigation include: Placebo (DRUG), ARGX-113 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02965573?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02965573 being conducted?
This trial has 19 study locations across California, Florida, Indiana, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02965573's enrollment target sits among peer trials
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