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A Phase III Study to Investigate Efficacy, Safety and Tolerability of Iptacopan Compared With Placebo in Participants Aged 18 to 75 Years With gMG.

Study on Iptacopan's effects and safety for gMG patients aged 18-75.

Recruiting
18-75 years
All
Phase 3

This study is for adults aged 18 to 75 years with a condition called generalized Myasthenia Gravis (gMG). gMG is a disease that affects how your muscles work, making them weak and tired. The study tests a new medicine called iptacopan against a fake (placebo) pill to see if it helps people with gMG feel better. Participants will be randomly chosen to receive either the real medicine or the placebo for 6 months while they keep taking their regular treatment for gMG. The study is double-blind, meaning neither the doctors nor the participants know who is getting the real treatment.

Eligibility includes having a positive test for AChR antibodies, which are proteins found in the blood of people with gMG. Participants must also have been dealing with gMG symptoms for a while and not be effectively managed with their current treatments.

Key Points:
  • The study lasts for 6 months of treatment, followed by a 24-month period where all participants can choose to receive iptacopan.
  • Participants must be vaccinated against certain infections before starting the study.
  • Women who are pregnant or planning to become pregnant cannot participate.
Study details
    Generalized Myasthenia Gravis

NCT06517758

Novartis Pharmaceuticals

8 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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