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Monoclonal Antibodies

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

Phase 2 & 3

Recruiting

Research Sponsored by argenx

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female adolescents of childbearing potential must have a negative urine pregnancy test at trial entry

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

ADAPT Jr + Trial Summary

This trial tests if a drug is safe for people who already took it in a previous trial.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include allergic reactions due to hypersensitivity to efgartigimod or its components. Participants will be monitored for any adverse events throughout the trial.

ADAPT Jr + Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

ADAPT Jr + Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in height from baseline

Changes in weight from baseline

Electrocardiogram - QTcF (ms)

+7 more

Secondary outcome measures

Incidence of antibodies against recombinant human hyaluronidase PH20 (rHuPH20)

Incidence of antidrug antibodies (ADAs) against efgartigimod

Prevalence of antibodies against recombinant human hyaluronidase PH20 (rHuPH20)

+1 more

ADAPT Jr + Trial Design

1Treatment groups

Experimental Treatment

Group I: Efgartigimod or Efgartigimod PH20 SCExperimental Treatment1 Intervention

Patients receiving Efgartigimod IV treatment or Efgartigimod PH 20 SC treatment

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

argenxLead Sponsor

60 Previous Clinical Trials

9,243 Total Patients Enrolled

12 Trials studying Myasthenia Gravis

3,785 Patients Enrolled for Myasthenia Gravis

Media Library

Efgartigimod IV (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05374590 — Phase 2 & 3

Myasthenia Gravis Research Study Groups: Efgartigimod or Efgartigimod PH20 SC

Myasthenia Gravis Clinical Trial 2023: Efgartigimod IV Highlights & Side Effects. Trial Name: NCT05374590 — Phase 2 & 3

Efgartigimod IV (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05374590 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project include elderly individuals above the age of 85?

"This clinical trial is recruiting patients ranging from 2 years through to 18 years of age."

Answered by AI

Is the recruitment phase of this trial still open?

"Affirmative. Evidenced by the information on clinicaltrials.gov, this research trial is in its recruitment phase and actively seeking participants. This initiative was first posted on August 18th 2022 and updated most recently on June 5th 2023; requiring 12 people to be signed up from 24 medical centres across the country."

Answered by AI

What is the scope of this clinical experiment in terms of participants?

"Affirmative. Clinicaltrials.gov data confirms that this medical trial, initially posted on August 18th 2022, is still searching for participants. In total, 12 patients need to be recruited from 24 different clinical sites."

Answered by AI

How many sites are hosting the research for this investigation?

"24 medical centres are currently enrolling participants for this study, such as US10003 in Chapel Hill, US10142 in Charlottesville and AT430010 in Vienna."

Answered by AI

Who would make the most suitable candidates for this research project?

"Patients between the ages of 2 and 18, who have been diagnosed with myasthenia gravis, are eligible to take part in this trial. A maximum of 12 participants will be enrolled."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis

2022. "Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05374590.

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