184 Participants Needed

Efgartigimod for Myasthenia Gravis

(ADAPTSC+ Trial)

Recruiting at 47 trial locations
AG
SC
Overseen BySabine Coppieters, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the quality of life (QoL) of the participants, treatment satisfaction, and administration method preference, and the feasibility of self- and caregiver-supported administration of the SC injection.Treatment duration: 3-week treatment periods, repeated as needed with at least 28 days in between treatment periodsHealth measurements: total levels of immunoglobulin G (IgG), Acetylcholine receptor binding autoantibodies (AChR-Ab) levels, Myasthenia Gravis Activities of Daly Living (MG-ADL).

Are You a Good Fit for This Trial?

This trial is for individuals with generalized myasthenia gravis who have previously participated in specific antecedent studies. They must be able to consent, use contraception, and not be pregnant or breastfeeding. Excluded are those allergic to the study drug or its components, recently had major surgery, have serious infections or diseases that could affect results or safety.

Inclusion Criteria

Previously participated in antecedent studies ARGX-113-2001 or ARGX-113-1705 and are eligible for roll over
Women of Child bearing potential (WOCBP) must have a negative urine pregnancy test at baseline before investigational medicinal product (IMP) can be administered
I can sign and follow the study's consent form and rules.
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Exclusion Criteria

I had cancer before but have been cancer-free for over 3 years.
I do not have serious health issues or recent major surgery that could risk my safety in the study.
I have had certain skin, cervical, breast, or early-stage prostate cancers but they are treated.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive efgartigimod PH20 SC 1000 mg in 3-week treatment periods, repeated as needed with at least 28 days in between treatment periods

Variable, based on individual needs

Follow-up

Participants are monitored for safety, tolerability, and clinical efficacy, including assessments of immunogenicity and quality of life

Up to 3.5 years

What Are the Treatments Tested in This Trial?

Interventions

  • efgartigimod PH20 SC
Trial Overview The trial tests the long-term safety of Efgartigimod PH20 SC (a subcutaneous injection) for treating myasthenia gravis. It looks at how well it works over time, its effects on quality of life and daily activities, and if patients can self-administer the treatment.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: efgartigimod PH20 SCExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

argenx

Lead Sponsor

Trials
76
Recruited
11,500+

Tim Van Hauwermeiren

argenx

Chief Executive Officer since 2008

B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management

Dr. Peter Ulrichts

argenx

Chief Medical Officer since 2023

MD from Maastricht University, PhD in Molecular Immunology from Maastricht University

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