This information is intended for U.S. residents only

Clinical Trials

Is Your Child Living With Generalized Myasthenia Gravis?

Adapt Jr Sc

Investigational Study Drug

Efgartigimod PH20 SC

Study Status
Recruiting

Clinical Study Code

ARGX-113-2207

Clinicaltrials.Gov Number
NCT06392386

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


Phase

2-3

Number of participants

Up to 12

Start date

June 2024

Study sites

16

The Adapt Junior SC study is designed to evaluate how the investigational study drug* may work (also known as efficacy) and how safe it is for the use in children living with gMG.

* The investigational study drug, efgartigimod PH20 SC, is not approved by any regulatory agency for use in pediatric patients living with gMG as efficacy and safety have not been established.

Eligibility


Your child may be eligible to participate if they:

  • Are between the ages of 2 and 18 (for US ages between 12 – 18)
  • Are diagnosed with gMG

Additional criteria to participate will apply which the study doctor will discuss with you.

What to expect


Screening - Up to 2 weeks

Treatment - 4 weeks

Follow up - Approximately 8 weeks

The study consists of 3 phases:

Sceening phase (2 weeks): up to 2 weeks before starting the study treatment, the study team will assess if your child meets the eligibility criteria.

Treatment phase (4 weeks): the investigational study drug will be given once per week (4 times) as an injection through a needle under the skin. The standard therapy for gMG will also be continued during the study.

Follow up phase (8 weeks): for approximately 8 weeks after the last dose of the investigational study drug. The study team will continue to monitor your child for safety. This will include physical check-ups, blood work and urine tests, and answering health-related questions.

Study participants who complete the Adapt Jr SC may choose to enroll in the open label extension safety study, where the study participant will receive the investigational study drug and continue to be monitored for safety.

Study locations


The clinical study sites are located across the world. Discover open study sites on the map.

Discover Locations for This Study

Study contact and resources


Adapt Jr Sc