RecruitingPHASE3INTERVENTIONAL

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

This research study is looking at a new medicine called nipocalimab for adults who have a condition called generalised myasthenia gravis, or gMG. gMG causes muscles to become weak and tired easily. The main aim of the study is to find out how well nipocalimab works compared to a 'dummy' medicine (placebo) and whether it is safe to use. The study also includes a smaller part to see how the body handles nipocalimab when it's given as an injection just under the skin, compared to giving it through a drip into a vein. This helps researchers understand the best way to give the medicine. Participants will either receive the active medicine or the placebo, and their health and symptoms will be carefully monitored throughout the study.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

199

Start

15 Jul 2021

Estimated completion

30 Mar 2029

Myasthenia Gravis

Results

Results from this study

Posted July 2025

Results have been published for this study.

Primary outcome

Double-blind (DB) Phase: Average Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24

Average change from baseline over multiple timepoints (Weeks 22, 23, and 24) was reported in this outcome measure. The MG-ADL provided a rapid assessment of the participant's MG symptom severity of eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, eyelid droop) rated on a 4-point scale ranging from 0 (normal) to 3 (severe). MG-ADL total score was sum of 8 individual items, which ranging from 0 to 24. A higher score indicated greater symptom severity. Baseline was defined as the average of the screening and Day 1 total scores.

Full results on the registry

What is this study about?

This research study is about a muscle weakness condition called generalised myasthenia gravis (gMG). If you have gMG, your body's immune system mistakenly attacks healthy connections between your nerves and muscles, leading to muscle weakness that can affect things like your eyes, face, throat, and limbs. This can make everyday activities quite challenging.

The study is testing a new medicine called nipocalimab. Researchers want to see if this medicine can help improve the symptoms of gMG and make a real difference to people's lives. To do this, they will compare nipocalimab to a 'dummy' treatment (called a placebo), which looks exactly like the real medicine but contains no active ingredients. This comparison helps them understand if any changes are truly due to nipocalimab or might have happened anyway.

Another important part of this study is looking at how nipocalimab works when given in different ways. Some participants will receive the medicine through a drip into a vein, which is a common way to give medicines. Others will receive it as an injection just under the skin. This helps the researchers figure out the most effective and convenient way to deliver the medicine, which could be very helpful for future patients.

Key takeaways

This study is testing a new medicine, nipocalimab, for generalised myasthenia gravis (gMG).
It aims to see if nipocalimab is safe and effective compared to a dummy treatment (placebo).
The medicine might be given through a drip or as an injection under the skin.
Participation involves regular clinic visits for treatments, tests, and symptom checks.
You will be closely monitored, and your care team will track your health.
You can withdraw from the study at any point without affecting your regular medical care.

Who may be eligible?

To join this study, adults must have a confirmed diagnosis of generalised myasthenia gravis (gMG) that affects various muscles in their body, not just a mild form. You would need to be experiencing specific levels of muscle weakness in your daily activities according to a special scale.

The study also has some rules about other health conditions. For example, you can't have certain problems with your immune system or a history of a 'myasthenia crisis' recently. If you've had surgery to remove your thymus gland, there's a time limit for when you can join after that surgery. Also, if you know you're allergic to nipocalimab or its ingredients, you wouldn't be able to take part.

For women who could become pregnant, special pregnancy tests are required, and male participants must agree not to donate sperm during the study and for a period after. If you're considering the part of the study where the medicine is given as an injection under the skin, you'd need suitable skin on your tummy for the injections and be able to keep your regular medications for gMG stable for the first few weeks.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a confirmed diagnosis of generalised myasthenia gravis (gMG)?
Are my gMG symptoms affecting my daily activities to a certain degree?
Have I had a thymectomy (surgery to remove my thymus gland) more than a year ago?
Do I have any specific immune problems or allergies that might stop me from joining?
Am I willing to attend regular clinic visits and follow the study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to either receive the new medicine, nipocalimab, or a placebo (a dummy medicine). You won't know which one you're getting, and neither will your study doctor. Depending on which group you're in, the medicine could be given through a drip into a vein or as an injection under your skin. This will involve regular visits to the study clinic for these treatments and check-ups.

Throughout the study, the research team will closely monitor your health, symptoms, and how you're feeling. This will involve various tests, blood samples, and questionnaires at regular visits. These visits are important for the team to understand how the medicine is working and to make sure you are safe. For some participants, there's a specific part of the study (called a substudy) where you'll receive injections under the skin. This will also involve keeping your current gMG medications, like steroids, at a steady dose for the first 8 weeks.

The total duration of your participation in the study will involve regular visits for treatment and assessments, followed by a period where your health is still monitored even after you stop receiving the study medicine. You will be given a detailed schedule of visits and procedures if you decide to take part, and you will always have the right to withdraw from the study at any time.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. You might benefit from receiving a new medicine that could improve your gMG symptoms, and you'll be closely monitored by a healthcare team. However, nipocalimab is still being tested, which means its full effects and side effects aren't completely known yet. You might experience side effects from the medicine, or it might not work for you. There's also a chance you could receive the placebo, which won't directly treat your gMG but will still involve clinic visits and procedures. As with any study, there's a small risk associated with blood draws and other tests. You have the right to stop taking part in the study at any time, for any reason, without it affecting your usual medical care.

Locations (112)

Neuromuscular Research Center and Clinic
Verified postcode
Paradise Valley, United States· Recruiting
HonorHealth Neurology
Verified postcode
Scottsdale, United States· Completed
University of Southern California
Verified postcode
Los Angeles, United States· Completed
Stanford University
Verified postcode
Palo Alto, United States· Completed
Care Access Research
Verified postcode
Pasadena, United States· Recruiting
University of Colorado Anschutz Medical Campus
Verified postcode
Aurora, United States· Recruiting
Yale New Haven Hospital
Verified postcode
New Haven, United States· Recruiting
FM Clinical Research, LLC South Florida Neurology Associates, P. A.
Verified postcode
Boca Raton, United States· Recruiting
University of Florida Health Jacksonville
Verified postcode
Jacksonville, United States· Completed
Medsol Clinical Research Center Inc
Verified postcode
Port Charlotte, United States· Recruiting
University of South Florida
Verified postcode
Tampa, United States· Recruiting
Augusta University
Verified postcode
Augusta, United States· Completed

Common questions

What is generalised myasthenia gravis (gMG)?

gMG is a condition where your body's immune system mistakenly attacks parts of your muscles, making them weak and tired easily, affecting many parts of your body.

What is nipocalimab?

Nipocalimab is a new medicine being tested to see if it can help improve the symptoms of gMG. It's not yet approved for general use.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the actual medicine but doesn't contain any active ingredients. It helps researchers fairly compare the new medicine's effects.

How will the medicine be given?

Depending on which group you're in, it could be given through a drip into your vein or as an injection just under your skin.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Study Contact

participate-in-this-study1@its.jnj.com 844-434-4210 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.