This study, Adapt Forward 2 , is designed to evaluate how the investigational study drug, empasiprubart* may work (also known as efficacy) and how safe it is for the use in adults living with gMG. This study will evaluate the investigational study drug (empasiprubart)* compared to a placebo.
Clinical Trials
Investigational Study Drug
Empasiprubart
Study Status
Recruiting
Clinical Study Code
ARGX-999-2-MG-20002
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).
* 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-Ab positive)
- Have not received efgartigimod or another FcRn antagonist within 4 weeks before the investigational study drug is administered
Additional criteria to participate apply which the study doctor will discuss.
What to expect
Screening -
Up to 5 weeks
Treatment –
Up to 12 weeks
Follow up –
Up to 28 weeks
The study consists of 3 phases in which you will undergo several tests and in which the investigational study drug will be administered.
Screening phase (up to 5 weeks): to perform tests to check eligibility to join this study.
Treatment phase: up to 12 weeks participation in the Double-blinded treatment phase. Participants are randomly assigned to a treatment group and will receive 4 doses of either empasiprubart (group 1) or placebo (group 2). There is 75% chance that you will be in group 1.
Follow up phase (up to 28 weeks): participants will receive 4 cycles of efgartigimod PH20 SC PFS**. The study team will continue to monitor you for safety. This will include physical check-ups, blood work and urine tests, and answering health-related questions.
**efgartigimod PH20 SC PFS is approved for use in generalized Myasthenia Gravis in adult patients who are acetylcholine receptor antibody (AChR-Ab) positive.
Study contact and resources
