A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG. (NCT06517758)
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Iptacopan in Patients With Generalized Myasthenia Gravis, Followed by an Open-label Extension Phase
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Honor Health Research Institute — Scottsdale, Arizona
Age range: 18 Years to 85 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (116 Sites)
Showing the first 25 of 116 sites.
- Honor Health Research Institute — Scottsdale, Arizona
- Fullerton Neuro and Headache Ctr — Fullerton, California
- California Pacific Medical Center — Sacramento, California
- Augusta University Georgia — Augusta, Georgia
- University of Chicago Medical Centr — Chicago, Illinois
- Prairie Heart Institute — Springfield, Illinois
- Mid Atlantic Epilepsy and Sleep Ctr — Bethesda, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- Henry Ford Health System — Detroit, Michigan
- Duke University Medical Center — Durham, North Carolina
- Penn Presbyterian Medical Center — Philadelphia, Pennsylvania
- Vanderbilt University Medical CenterX — Nashville, Tennessee
- Nerve and Muscle Center of Texas — Houston, Texas
- Novartis Investigative Site — CABA, Buenos Aires
- Novartis Investigative Site — Córdoba, Córdoba Province
- Novartis Investigative Site — Rosario, Santa Fe Province
- Novartis Investigative Site — Buenos Aires,
- Novartis Investigative Site — Caba,
- Novartis Investigative Site — Caba,
- Novartis Investigative Site — Capital Federal,
- Novartis Investigative Site — Córdoba,
- Novartis Investigative Site — Camperdown, Sydney
- Novartis Investigative Site — Porto Alegre, Rio Grande do Sul
- Novartis Investigative Site — Porto Alegre, Rio Grande do Sul
- Novartis Investigative Site — Joinville, Santa Catarina
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Generalized Myasthenia Gravis
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- A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis — Scottsdale, Arizona
- Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis — Orange, California
- Evaluation of PK, PD, Efficacy, Safety, and Immunogenicity of IV Ravulizumab in Pediatric Participants With Generalized Myasthenia Gravis — Los Angeles, California
- Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis — Phoenix, Arizona
Explore by condition: All Generalized Myasthenia Gravis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.