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ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis – Active and Recruiting

Brief Summary

ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.

Sponsor: argenx
Study website: https://clinicaltrials.argenx.com/adaptforward
Webpage: https://www.clinicaltrials.gov/study/NCT07294170
Study Contact:  clinicaltrials@argenx.com

ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod – Active and Recruiting

Brief Summary

This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.

The aim of this ISA1 is to evaluate the safety and therapeutic relevance of empasiprubart as add-on therapy to efgartigimod in participants with AChR-Ab seropositive generalized myasthenia gravis.

Sponsor: argenx
Study website: https://clinicaltrials.argenx.com/adaptforward1
Webpage:  https://clinicaltrials.gov/study/NCT07284420
Study Contact:  clinicaltrials@argenx.com

A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG) (ADAPT-EARLY) – Recruiting

Brief Summary

The main purpose of this study is to measure how well adults with new-onset gMG (which means they've had generalized disease signs and/or symptoms for less than 1 year) respond to treatment with efgartigimod PH20 SC. The study consists of a treatment period of 51 weeks. The study duration for each participant will be approximately 58 weeks.

Sponsor: argenx
Webpage:  https://clinicaltrials.gov/study/NCT06909214
Study contact: clinicaltrials@argenx.com

Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis (ADAPT Jr)– Recruiting

Brief Summary

The purpose of this trial is to investigate the PK, PD, safety, and activity of efgartigimod IV in children and adolescents aged from 2 to less than 18 years of age with gMG.

Trial details include:

• The maximum trial duration for each individual participant will be approximately 28 weeks• The treatment duration will be 8 weeks for the dose-confirmatory part (Part A) and 18 weeks for the treatment response-confirmatory part (Part B)

Sponsor: argenx
Webpage: https://clinicaltrials.gov/study/NCT04833894
Study contact:  clinicaltrials@argenx.com

A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis (ADAPT Jr SC) – Recruiting

Brief Summary

The purpose of this study is to measure the pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability, and immunogenicity of efgartigimod PH20 SC in pediatric participants with gMG aged 2 to <18 years. The primary goal is to confirm an appropriate dose of efgartigimod PH20 SC for pediatric patients using PK and PD results from this study. Participants will receive injections of efgartigimod PH20 SC and will be monitored for safety until the end of the study. At the end of the follow-up period, eligible participants may roll over to an open-label extension (OLE) study.

The participants will be in the study for up to 14 weeks.

Sponsor: argenx
Webpage: https://clinicaltrials.gov/study/NCT06392386
Study contact:  clinicaltrials@argenx.com

A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa – Recruiting

Brief Summary

This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.

Sponsor: argenx
Webpage:https://clinicaltrials.gov/study/NCT006298565

Study contact: clinicaltrials@argenx.com

A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/​or Breastfeeding. – Recruiting

Brief Summary

This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod or efgartigimod PH20 SC only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the efgartigimod or efgartigimod PH20 SC exposed pregnancies were reported.

Sponsor: argenx
Webpage: https://clinicaltrials.gov/study/NCT006299748
Study contact: clinicaltrials@argenx.com

A Natural History Study in Participants With Congenital Myasthenic Syndromes (CMS) Due to Mutations in DOK7, MUSK, AGRN, or LRP4

Brief Summary

Participants will attend up to 4 study visits to collect clinical assessments. The assessments will evaluate participants' symptoms and quality of life to understand disease activity in patients with CMS due to mutations in DOK7, MUSK, AGRN, or LRP4.

Sponsor: argenx
Study Webpage: https://clinicaltrials.argenx.com/cms
Webpage: https://clinicaltrials.gov/study/NCT06078553
Study contact: clinicaltrials@argenx.com