Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06517758
The ClinicalTrials.gov registry entry for NCT06517758 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 126-participant average among 26 other Generalized Myasthenia Gravis trials with a reported enrollment target (16% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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
Similar trials for Generalized Myasthenia Gravis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)
RECRUITING · Phase 3
-
A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG)
RECRUITING · Phase 3
-
A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis
RECRUITING · Phase 3
-
PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis
RECRUITING · Phase 3
-
Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
RECRUITING · Phase 3
-
Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis
ACTIVE NOT RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.