RecruitingPHASE2INTERVENTIONAL

A Phase 2 Study to Evaluate Povetacicept in Adults With Generalized Myasthenia Gravis

This research study is about a new treatment called Povetacicept for adults (18-80 years old) who have generalized myasthenia gravis (gMG). This condition causes muscle weakness. In the study, some people will receive Povetacicept, while others will receive a placebo (a dummy treatment, like a sugar pill) to see if the new medicine works better. The main goals are to understand how Povetacicept affects the body, how well it's tolerated, and if it's safe. This is a 'Phase 2' study, which means it's an early stage of testing to get more information before potentially moving to larger studies.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Vertex Pharmaceuticals Incorporated

Enrolment target

Start

13 May 2026

Estimated completion

02 Mar 2029

Myasthenia Gravis, Generalized

What is this study about?

This research is looking into a new medication called Povetacicept for people who have generalized myasthenia gravis, often shortened to gMG. Myasthenia gravis is a condition that causes muscle weakness throughout the body because the immune system mistakenly attacks healthy tissues.

The main aim of this study is to learn more about how Povetacicept works in the body. We want to understand what effects it has on the condition and if it's absorbed and used as expected. We also want to make sure the medication is safe for people to take and that it doesn't cause too many side effects.

This is a 'Phase 2' study. This means it's an important step after initial safety tests, but before very large studies are done. It helps researchers decide if the medication is promising enough to continue developing. Some participants will receive the new medicine, while others will receive a 'placebo' – a treatment that looks the same but contains no active medicine. This helps researchers fairly compare how well the new medicine works.

Key takeaways

This study is for adults with generalized myasthenia gravis (gMG).
It's testing a new medicine called Povetacicept against a dummy treatment (placebo).
The main goals are to check the medicine's safety and how it works in the body.
This is a Phase 2 study, an important step in testing new treatments.
Participation involves regular clinic visits for check-ups and medication.

Who may be eligible?

To be part of this study, you need to be an adult between 18 and 80 years old and have been diagnosed with generalized myasthenia gravis. This means your muscle weakness affects different parts of your body. Your doctor will also need to confirm that your myasthenia gravis falls within certain levels of severity.

There are also some important reasons why you might not be able to join. For example, if you've had surgery on your thymus gland in the last six months, or if you've had certain types of cancer in the last five years, you wouldn't be able to take part. There are other specific health conditions or treatments that might also prevent someone from joining, which your study doctor will discuss with you.

Essentially, the study is designed for a specific group of people to make sure the results are clear and safe. Your doctor will carefully check all the details to see if this study is suitable for you.

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.

Are you between 18 and 80 years old?
Have you been diagnosed with generalized myasthenia gravis?
Have you had thymic surgery more than 6 months ago?
Have you been free from cancer for the last 5 years?
Are you able to attend regular study appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to either receive the new medicine, Povetacicept, or a placebo (a dummy treament). You wouldn't know which one you're getting, and neither would the study team, to keep the results fair. You would need to attend several appointments at the study clinic for check-ups, tests, and to receive your study medication. These appointments would involve things like physical exams, blood tests, and questions about how you're feeling and any changes in your muscle weakness. There would also be follow-up appointments after you finish taking the study medicine to make sure everything is okay. The total length of your involvement in the study would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in this study might offer some potential benefits, such as receiving a new medicine for your condition that isn't yet widely available, or getting extra close medical monitoring. However, there's no guarantee that Povetacicept will help your condition, and there's a chance you could receive the placebo. There are also potential risks involved, including possible side effects from the medication. The study team will explain all the known risks and potential side effects to you before you decide. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (24)

Neurology Offices
Verified postcode
Boca Raton, United States· Recruiting
SFM Clinical Reseach, LLC
Verified postcode
Boca Raton, United States· Recruiting
Homestead Associates in Research
Verified postcode
Homestead, United States· Recruiting
UF Health Jacksonville Respiratory Therapy (PFT and DLCO)
Verified postcode
Jacksonville, United States· Recruiting
Y & L Advance Health Care, Inc D/B/A Elite Clinical Research - Neurology
Verified postcode
Miami, United States· Recruiting
Quantix Research
Verified postcode
Miami, United States· Recruiting
Hawaii Pacific Neuroscience
Verified postcode
Honolulu, United States· Recruiting
HSHS Medical Group - St. Elizabeth's Hospital
Verified postcode
O'Fallon, United States· Recruiting
Las Vegas Neurology Center
Verified postcode
Las Vegas, United States· Recruiting
Clinical Trials of South Carolina - Neurology
Verified postcode
Charleston, United States· Recruiting
Ut Erlanger Neurology
Verified postcode
Chattanooga, United States· Recruiting
Nerve and Muscle Center of Texas - Neurology
Verified postcode
Houston, United States· Recruiting

Common questions

What is 'generalized myasthenia gravis'?

It's a condition where your immune system mistakenly attacks your muscles, causing weakness that can affect many parts of your body.

What does a 'Phase 2 study' mean?

It's an early stage of testing for a new medicine. It helps researchers understand how safe it is and how well it works before larger studies.

What is a 'placebo'?

A placebo is a dummy treatment that looks like the real medicine but contains no active ingredients. It helps compare the new medicine fairly.

Will I get help with travel costs if I join?

You should ask the study team if they offer any help with travel or other expenses for attending appointments.

What if I change my mind after joining?

You are free to leave the study at any time, for any reason, without it affecting your usual medical care.

How to find out more

Medical Information

medicalinfo@vrtx.com 617-341-6777 Official trial record

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