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NCT06517758 · ClinicalTrials.gov registry record · Phase 3
A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG.
A Phase 3 study of Generalized Myasthenia Gravis, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 146
- Enrollment target
- 20
- Study locations
NCT06517758: Recruiting Phase 3 study of Generalized Myasthenia Gravis, sponsored by Novartis Pharmaceuticals.
NCT06517758 is a Phase 3 study of Generalized Myasthenia Gravis that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 146 participants, above the 126-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (16% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06517758, a Phase 3 study of Generalized Myasthenia Gravis, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 146 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate efficacy, safety and tolerability of iptacopan in patients with AChR+ gMG who are on stable SOC treatment. Participants who meet the eligibility criteria will be randomized in a ratio of 1:1, to receive either iptacopan or matching placebo, for 6 months (180 days) while continuing on a stable SOC treatment. The randomization will be stratified based on region.
Primary Outcome
The MG-ADL is an 8 item interviewer led patient reporting scale that assesses MG symptoms and their effects on daily activities. MG-ADL is composed of items related to patient's assessment of functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. Each item is assessed on a 4-points scale where a score 0 represents normal function and a score 3 represents loss of ability to perform that
Conditions Studied
Interventions
- OTHER Matching Placebo
- DRUG Iptacopan
Study Locations (20)
California
- Fullerton Neuro and Headache Ctr - Fullerton
- SC3 Research Pasadena - Pasadena
- California Pacific Medical Center - Sacramento
Florida
- Neurology Offices Of South Florida - Boca Raton
- Superior Associates in Research LLC - Hialeah
Illinois
- University of Chicago Medical Centr - Chicago
- Prairie Heart Institute - Springfield
Ohio
- Neuroscience Research Ctr - Canton
- Ohio State University Medical Center - Columbus
Texas
- Nerve and Muscle Center of Texas - Houston
- Central TX Neuro Consultants P A - Round Rock
Arizona
- Honor Health Research Institute - Scottsdale
Georgia
- Augusta University Georgia - Augusta
Hawaii
- Hawaii Pacific Neuroscience LLC - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2024-07-31 |
| Est. Completion | 2032-05-27 |
| Phase | Phase 3 |
What NCT06517758 shows while recruiting
NCT06517758 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, above the 126-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (16% higher).
The record links to 1 condition, with Generalized Myasthenia Gravis appearing as the primary indexed condition, and to 2 interventions - of which Matching Placebo is the first listed.
NCT06517758 names 20 study sites across 14 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT06517758 about?
NCT06517758 is a clinical study titled "A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG.". The study is a randomized, double-blind, placebo-controlled, multicenter, Phase III study, to evaluate efficacy, safety and tolerability of iptacopan in patients with AChR+ gMG who are on stable SOC treatment. Participants who meet the eligibility criteria will be randomized in a ratio of 1:1, to re...
What is the current status of trial NCT06517758?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 146 participants. The study started on 2024-07-31. Estimated completion is 2032-05-27.
What conditions does trial NCT06517758 study?
This clinical trial studies the following conditions: Generalized Myasthenia Gravis.
What interventions are being tested in trial NCT06517758?
The interventions under investigation include: Matching Placebo (OTHER), Iptacopan (DRUG).
Who is sponsoring clinical trial NCT06517758?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06517758 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06517758's enrollment target sits among peer trials
146 12th of 26 higher than 15 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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