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NCT06517758 · ClinicalTrials.gov record · last posted 2026-08-12

A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 85 Years With gMG.

StatusActive, Not Recruiting
PhasePhase 3
Started2024-07-31
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 4 changes detected by DataLookout

2026-08-13
Enrollment closed, study ongoing
2026-08-13
Trial sites reduced: 125 → 116 locations
2026-05-28
Trial sites expanded: 113 → 124 locations
2026-03-31
Trial sites expanded: 105 → 110 locations
Trial Details
NCT Number NCT06517758
Lead Sponsor Novartis Pharmaceuticals
Conditions Generalized Myasthenia Gravis
Enrollment 146 participants
Start Date 2024-07-31
Primary Completion 2027-04-30 (estimated)
Study Completion 2032-05-27 (estimated)
Updated on ClinicalTrials.gov 2026-08-12