Efgartigimod for Myasthenia Gravis

(ADAPTSC+ Trial)

Recruiting at47 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: argenx

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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 periods Health measurements: total levels of immunoglobulin G (IgG), Acetylcholine receptor binding autoantibodies (AChR-Ab) levels, Myasthenia Gravis Activities of Daly Living (MG-ADL).

Research Team

Eligibility Criteria

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.

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.

Treatment Details

Interventions

• efgartigimod PH20 SC (Monoclonal Antibodies)

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.

Participant Groups

Group I: efgartigimod PH20 SC Experimental Treatment 1 Intervention

Patients receiving efgartigimod PH20 subcutaneous (SC) treatment

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