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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2026-05-14

No results posted yet for this 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

Interventions

DRUG

Iptacopan

Hard gelatin capsule

OTHER

Matching Placebo

Hard gelatin capsule

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2027-04-30
Completion
2032-05-27
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • China
  • Denmark
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • Poland
  • Portugal
  • Serbia
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06517758 on ClinicalTrials.gov