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NCT04115293 · ClinicalTrials.gov registry record · Phase 3
Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis
A Phase 3 study, sponsored by Ra Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 174
- Enrollment target
NCT04115293: Completed Phase 3 study, sponsored by Ra Pharmaceuticals.
NCT04115293 is a Phase 3 study that has completed, run by Ra Pharmaceuticals. The registered enrollment target is 174 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04115293, a Phase 3 study, has completed, sponsored by Ra Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 174 participants
- Enrollment target
Study Summary
The RAISE study is a multicenter, randomized, double-blind, placebo controlled study to confirm the efficacy, safety, and tolerability of zilucoplan in subjects with generalized Myasthenia Gravis. Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or placebo for 12 weeks.
Primary Outcome
The MG-ADL is an 8-item patient-reported outcome measure assessing MG symptoms and their effects on daily activities. Each item in the scale scored 0 to 3 (0=None, 3=severe disease) point scale. The total score was the sum of all individual item scores and ranged from 0 to 24. Higher scores indicated more severe disability due to MG. A decrease from Baseline score indicated improvement.
Interventions
- DRUG Placebo
- DRUG zilucoplan (RA101495)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2019-09-17 |
| Est. Completion | 2021-12-30 |
| Phase | Phase 3 |
What the finished NCT04115293 record still lists
NCT04115293 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04115293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04115293 about?
NCT04115293 is a clinical study titled "Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis". The RAISE study is a multicenter, randomized, double-blind, placebo controlled study to confirm the efficacy, safety, and tolerability of zilucoplan in subjects with generalized Myasthenia Gravis. Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or placebo...
What is the current status of trial NCT04115293?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 174 participants. The study started on 2019-09-17. Estimated completion is 2021-12-30.
What interventions are being tested in trial NCT04115293?
The interventions under investigation include: Placebo (DRUG), zilucoplan (RA101495) (DRUG).
Who is sponsoring clinical trial NCT04115293?
This trial is sponsored by Ra Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04115293's enrollment target sits among peer trials
174 1442nd of 2000 higher than 556 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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