Long-term Safety of Efgartigimod for Myasthenia Gravis
(ADAPT Jr + Trial)

Recruiting in Palo Alto (17 mi)

+43 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: argenx

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing the long-term safety of two forms of a medication called efgartigimod, given either through a drip or as an injection. It is aimed at patients with generalized Myasthenia Gravis, a condition that causes muscle weakness. The medication works by lowering harmful proteins in the blood that attack muscles.

Eligibility Criteria

This trial is for children who have a muscle weakness condition called generalized myasthenia gravis and were part of an earlier study (ARGX-113-2006). They must not plan to donate sperm or become pregnant, agree to use contraception, and understand the trial's requirements. Those with hypersensitivity to efgartigimod, recent live vaccines, other autoimmune diseases, or uncontrolled infections cannot join.

Inclusion Criteria

Participants must have completed ARGX-113-2006 or ARGX-113-2207 and agreed to participate in the ARGX-113-2008 trial

I am a female of childbearing age and my pregnancy test before the trial was negative.

Participants who qualify for retreatment in trial ARGX-113-2006 but cannot complete the required visits within the trial's timeframe

+2 more

Exclusion Criteria

Known hypersensitivity reaction to efgartigimod or any of its excipients

Early discontinuation from ARGX-113-2006 or ARGX-113-2207 treatment

I do not have an autoimmune disease or any condition that could affect my gMG symptoms or increase my risk.

+2 more

Participant Groups

The trial is testing the long-term safety of a medication called Efgartigimod IV in children who previously participated in another related study. It aims to ensure that this treatment continues to be safe over an extended period.

1Treatment groups

Experimental Treatment

Group I: Efgartigimod or Efgartigimod PH20 SCExperimental Treatment1 Intervention

Patients receiving Efgartigimod IV treatment or Efgartigimod PH 20 SC treatment

Efgartigimod IV is already approved in United States, European Union, United States for the following indications:

🇺🇸 Approved in United States as Vyvgart for:

Generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive

🇪🇺 Approved in European Union as Vyvgart for:

Generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive

🇺🇸 Approved in United States as Vyvgart Hytrulo for:

Generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive
Chronic inflammatory demyelinating polyneuropathy (CIDP)