The study will evaluate if combining the approved drug called efgartigimod* and a new investigational study drug called empasiprubart** is safe and how it may work in people living with gMG. Efgartigimod and empasiprubart, are combined as their mode of action is believed to work synergistically.
Clinical Trials
Investigational Study Drug
Efgartigimod / Empasiprubart
Study Status
Start up
Clinical Study Code
ARGX-999-2-MG-20001
About gMG
Generalized myasthenia gravis (gMG) is a rare autoimmune disease in which the body’s defense system attacks the connection point between nerves and muscles. This can cause double vision, drooping of the eyelids, and difficulty swallowing, talking, breathing, and using the arms and legs.
About this clinical research study
The study is part of the Adapt Forward Platform that includes several studies designed for people living with myasthenia gravis (MG).
* Efgartigimod is approved for use in generalized myasthenia gravis in adult patients who are acetylcholine receptor (AChR) antibody positive.
** The investigational study drug, empasipubart is not approved by any regulatory agency for use in gMG as efficacy and safety have not been established.
Eligibility
You may be eligible to participate if you:
- Are diagnosed with gMG (AchR seropositive)
- Received efgartigimod for at least 1 treatment cycle but responded partially to it or you never received efgartigimod before
Additional criteria to participate apply which the study doctor will discuss.
What to expect
Screening -
Up to 5 weeks
Treatment –
Part A 7 weeks, Part B 14 weeks
Follow up –
28 weeks
The study consists of 3 phases in which you will undergo several tests and in which the investigational study drug(s) will be administered.
Screening phase (up to 5 weeks): to perform tests to check eligibility to join this study.
Treatment phase: consists of a part A (7 weeks) and a part B (14 weeks). In part A, the participants receive efgartigimod, in Part B they receive efgartigimod and empasiprubart. The participants will go to part B if their gMG symptoms only partially improved. If their symptoms improved sufficiently in part A they will go directly to the follow up phase. If their symptoms did not improve in Part A, they will also go directly to the follow up phase.
Follow up phase (28 weeks): participants will further receive efgartigimod treatment and the study team will continue to monitor them for safety. This will include physical check-ups, blood work and urine tests, and answering health-related questions.
Study contact and resources
