← Back to Search

Monoclonal Antibodies

Efgartigimod IV for Myasthenia Gravis (ADAPT SERON Trial)

Phase 3

Recruiting

Research Sponsored by argenx

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 29 days during part a

Awards & highlights

ADAPT SERON Trial Summary

This trial is testing a drug called efgartigimod given intravenously to see if it is effective and safe for people with Generalized Myasthenia Gravis. The study will

Who is the study for?

This trial is for adults with seronegative Generalized Myasthenia Gravis (gMG), who can consent and follow the study plan. They must use birth control if applicable, have a negative pregnancy test if female, and show signs of MG that improve with certain treatments or tests.Check my eligibility

What is being tested?

The study compares Efgartigimod IV to a placebo in treating gMG. Participants are randomly chosen to receive either the drug or placebo. Those completing this part will later all receive Efgartigimod in an open-label extension.See study design

What are the potential side effects?

Possible side effects of Efgartigimod include reactions at the injection site, headaches, fatigue, and potential changes in immune response which could increase infection risk or cause other immune-related issues.

ADAPT SERON Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 29 days during part a

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 29 days during part a

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 29 days during part a for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Myasthenia Gravis Activities of Daily Living (MG-ADL) total score change from baseline

Secondary outcome measures

Proportion of participants who are both MG-ADL and QMG responders

Quantitative myasthenia gravis (QMG) total score change from baseline

ADAPT SERON Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Efgartigimod IVExperimental Treatment1 Intervention

Patients receiving efgartigimod IV in both part A and part B

Group II: PlaceboPlacebo Group2 Interventions

Patients receiving placebo during part A and receiving efgartigimod IV during part B

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

argenxLead Sponsor

61 Previous Clinical Trials

9,157 Total Patients Enrolled

13 Trials studying Myasthenia Gravis

3,699 Patients Enrolled for Myasthenia Gravis

Frequently Asked Questions

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

Are individuals currently able to apply and participate in this ongoing research study?

"As per information on clinicaltrials.gov, this investigation is currently open for patient recruitment. Initially shared on April 16th, 2024, the trial's latest update was made on April 22nd of the same year."

Answered by AI

What is the current number of individuals eligible for enrollment in this clinical research study?

"Indeed, the details on clinicaltrials.gov affirm that this investigation is currently in search of participants. Initially shared on April 16th, 2024, and later updated on April 22nd, 2024, the study aims to enroll a total of 110 patients at a single designated site."

Answered by AI

Has the intravenous form of Efgartigimod been officially approved by the FDA?

"The safety evaluation of Efgartigimod IV conducted by our team at Power has been rated as 3 on the scale. This rating is attributed to the Phase 3 trial status, indicating a substantial foundation of efficacy data with extensive rounds of safety data collection."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

2024. "A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06298552.

All > Miami > Myasthenia Gravis