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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
Sponsorargenx

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Is at least 18 years of age and the local legal age of consent for clinical studies

Has been diagnosed with MG with consistent clinical features per the investigator's clinical judgment

If receiving MG therapy, including nonsteroidal immunosuppressive drugs (NSIDs), corticosteroids, or acetylcholinesterase (AChE) inhibitors either in combination or alone, the participant should receive a stable dosage before master protocol screening

Disqualifiers

Known autoimmune disease or any medical condition other than the indication under study that would interfere with an accurate assessment of clinical symptoms of MG or puts the participant at undue risk

Is MGFA (Myasthenia Gravis Foundation of America) Class V

Trial population

Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Efgartigimod IV

    Biological/Vaccine

    Intravenous infusion of efgartigimod

  • Empasiprubart IV

    Biological/Vaccine

    Intravenous infusion of empasiprubart

  • Placebo IV

    Other intervention

    Intravenous infusion of placebo

  • Efgartigimod PH20 SC PFS

    Biological/Vaccine

    Subcutaneous administration of Efgartigimod PH20 via pre-filled syringe (PFS)

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: ISA1 participants2 interventions
Group B: ISA2 participants3 interventions

Trial outcomes

Primary outcomes

1

To determine the safety and tolerability of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes

Time frame
Up to approximately 7 years (the duration of each ISA will vary and be specified on the ISA records)

Secondary outcomes

1

To evaluate the efficacy of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes

Each ISA record will specify the correct scale and time point

Time frame
Up to approximately 7 years (the duration of each ISA will vary and be specified on the ISA records)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.