Active not recruitingPHASE3INTERVENTIONAL

Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis

This research study is for adults with a muscle weakness condition called generalized Myasthenia Gravis (gMG). It's testing a new medicine called batoclimab to see how effective and safe it is. Participants will receive batoclimab at different doses or a 'dummy' medicine (placebo) initially. We want to find out if batoclimab can improve daily activities for people with gMG. If the medicine helps, participants might continue to receive it for a longer time. The study will carefully monitor everyone to understand the medicine's effects and any possible side effects. This is a chance to help develop new treatments for gMG and potentially improve the lives of many people.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Immunovant Sciences GmbH

Enrolment target

240

Start

27 Jun 2022

Estimated completion

01 Feb 2027

Generalized Myasthenia Gravis

What is this study about?

This study is about a new medicine called batoclimab for people who have generalized Myasthenia Gravis, often shortened to gMG. Myasthenia Gravis is a condition that causes muscle weakness. When doctors say "generalized," it means the muscle weakness can affect different parts of the body, not just one specific area. The main goal of this research is to see if batoclimab can help improve daily life for people with gMG and if it's safe to use.

Researchers will be looking closely at how people's symptoms change during the study. They will use special scores that measure how gMG affects everyday activities like eating, talking, or moving around. This helps them understand whether batoclimab is making a real difference. Some people will get batoclimab, and others will get a placebo, which is a dummy medicine that looks just like the real thing but has no active ingredients. This is a common way to test new medicines fairly, so researchers can be sure any improvements are due to batoclimab.

This is a "Phase 3" study, which means it's one of the final steps before a new medicine might be approved for wider use. It's an important stage for confirming the medicine's benefits and understanding its safety in a larger group of people. If batoclimab works well in this study, it could offer a new treatment option for people living with gMG.

Key takeaways

This study is testing a new medicine, batoclimab, for generalized Myasthenia Gravis (gMG).
It aims to see if batoclimab improves gMG symptoms and is safe to use in adults.
Participants will receive injections of batoclimab or a placebo.
Regular check-ups and assessments will monitor your health and symptoms.
The study could lead to a new treatment option for gMG.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. You must have generalized Myasthenia Gravis (gMG), and your condition should be classified as mild to severe. Doctors will check this using specific scoring systems during your screening appointments.

There are also certain reasons why you might not be able to join. For example, if you've recently had a serious flare-up of your gMG called a myasthenic crisis, or if you've had a specific type of surgery called a thymectomy in the last six months (or have one planned soon). Also, if you have certain types of cancer or have recently had other treatments that affect your immune system, you might not be able to take part.

The research doctors will carefully review your full medical history to make sure this study is safe and right for you. It's important that any treatment you receive during the study doesn't interfere with your current health or other medicines you might be taking.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of generalized Myasthenia Gravis (gMG)?
Have you avoided a myasthenic crisis in the last 3 months?
Have you avoided a thymectomy surgery in the last 6 months, and don't have one planned soon?
Are you able to attend regular clinic appointments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, the study will involve several visits to the clinic over a period of time. Initially, you'll be randomly assigned to receive either batoclimab (at one of two different doses) or a dummy medicine called a placebo. Both the medicine and the placebo will be given as injections under your skin, usually once a week. You won't know if you're getting the active medicine or the placebo, and neither will the study team.

After a few months, if you were receiving batoclimab and it helped, you might be reassigned to continue with batoclimab (at different doses or frequency) or receive placebo again. If you continue to respond well to batoclimab, you could potentially stay on the treatment for a much longer time in extension parts of the study. Throughout the study, you'll have regular check-ups, blood tests, and assessments to see how your gMG symptoms are changing and to monitor for any side effects. The study length will vary depending on which parts you are eligible for, with potential for long-term follow-up.

Potential risks and benefits

Taking part in a research study has potential benefits and potential risks. You might benefit from the study medicine, batoclimab, which could improve your gMG symptoms. You'll also receive careful medical monitoring and contribute to scientific knowledge that could help others with gMG in the future. However, there's always a chance the medicine might not help you, or you might receive the placebo. Like all medicines, batoclimab could have side effects, which the study team will discuss with you. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (93)

Site Number -1022
Phoenix, United States
Site Number -1029
Scottsdale, United States
Site Number -1002
Carlsbad, United States
Site Number -1009
Irvine, United States
Site Number - 1012
Olive View, United States
Site Number -1032
San Francisco, United States
Site Number - 1027
Aurora, United States
Site Number - 1025
New Haven, United States
Site Number -1007
Clearwater, United States
Site Number -1010
Maitland, United States
Site Number - 1020
Miami, United States
Site Number - 1019
Orlando, United States

+81 more sites — see the official record for the full list.

Common questions

What is Myasthenia Gravis (gMG)?

It's a long-term condition that causes muscle weakness. It can affect muscles that control your eyes, face, throat, and limbs.

What is batoclimab?

Batoclimab is a new medicine being tested. It aims to reduce muscle weakness in people with gMG.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the study medicine but doesn't contain any active ingredients. It helps researchers fairly compare how well the real medicine works.

Will I know if I'm getting the real medicine or the placebo?

No, you won't know, and neither will the study staff initially. This is called 'blinding' and helps ensure the study results are accurate.

How will the medicine be given?

The medicine or placebo will be given through injections under your skin, usually once a week.