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NCT03315130 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis
A Phase 2 study of Generalized Myasthenia Gravis, sponsored by Ra Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 20
- Study locations
NCT03315130: Completed Phase 2 study of Generalized Myasthenia Gravis, sponsored by Ra Pharmaceuticals.
NCT03315130 is a Phase 2 study of Generalized Myasthenia Gravis that has completed, run by Ra Pharmaceuticals. The registered enrollment target is 45 participants, below the 129-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03315130, a Phase 2 study of Generalized Myasthenia Gravis, has completed, sponsored by Ra Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with generalized Myasthenia Gravis (gMG). Subjects will be randomized in a 1:1:1 ratio to receive daily SC doses of 0.1 mg/kg RA101495, 0.3 mg/kg RA101495, or matching placebo for 12 weeks.
Primary Outcome
The QMG is a standardized and validated quantitative strength scoring system that was developed specifically for myasthenia gravis (MG). The scale consists of 13 individual assessments, each scored on a 0-3 point scale (i.e., 0=none, 1=mild, 2=moderate, and 3=severe). The total score is the sum of the individual scores with a range of 0-39. Higher scores are representative of more severe impairment.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG zilucoplan (RA101495)
Study Locations (20)
California
- The Research Center of Southern California - Carlsbad
- UCLA Medical Center - Los Angeles
- University of California Irvine Health ALS and Neuromuscular Center - Orange
New York
- University of Buffalo - Buffalo
- Hospital for Special Surgery - New York
- Mount Sinai Hospital - New York
Florida
- University of Florida - Jacksonville
- University of South Florida - Tampa
Massachusetts
- Massachusetts General Hospital - Boston
- Lahey Hospital and Medical Center - Burlington
Michigan
- Wayne State University - Detroit
- Michigan State University - East Lansing
Alabama
- Diagnostic and Medical Clinic - Mobile - Mobile
Connecticut
- Yale University - New Haven
District of Columbia
- George Washington University - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2017-10-11 |
| Est. Completion | 2020-11-19 |
| Phase | Phase 2 |
What the finished NCT03315130 record still lists
NCT03315130 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 129-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Generalized Myasthenia Gravis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03315130 names 20 study sites across 13 states, led by California, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT03315130 about?
NCT03315130 is a clinical study titled "Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis". The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with generalized Myasthenia Gravis (gMG). Subjects will be randomized in a 1:1:1 ratio to receive daily SC doses of 0.1 mg/kg RA101495, 0.3 mg/kg RA101495, or matching placebo for 12 weeks.
What is the current status of trial NCT03315130?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2017-10-11. Estimated completion is 2020-11-19.
What conditions does trial NCT03315130 study?
This clinical trial studies the following conditions: Generalized Myasthenia Gravis.
What interventions are being tested in trial NCT03315130?
The interventions under investigation include: Placebo (DRUG), zilucoplan (RA101495) (DRUG).
Who is sponsoring clinical trial NCT03315130?
This trial is sponsored by Ra Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03315130 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03315130's enrollment target sits among peer trials
45 18th of 26 higher than 9 of 26 other Generalized Myasthenia Gravis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Generalized Myasthenia Gravis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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