ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Efgartigimod IV, Empasiprubart IV, Placebo IV, Efgartigimod PH20 SC PFS.
- Who it may be relevant to
- Registry conditions: Myasthenia Gravis, MG, gMG, Generalized Myasthenia Gravis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, Germany, Greece, Italy +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
Overview
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.
Detailed description
This is a platform study and is governed by a single master protocol that enables multiple regimens to be evaluated in separate intervention-specific appendixes (ISAs).
The key design structure of the platform study comprises: common master protocol screening period, ISA-specific screening period, ISA treatment period of variable duration and design and ISA safety follow-up/follow-up period of variable duration.
Details on each study period will be specified in the ISAs. Following ISAs are included in this platform study:
* NCT07284420 - ADAPT Forward 1 - 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 (https://www.clinicaltrials.gov/study/NCT07284420) * NCT07673627 - Adapt Forward 2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis (https://clinicaltrials.gov/study/NCT07673627)
More information can be found here: https://clinicaltrials.argenx.com/adaptforward
Interventions
- Biological Efgartigimod IV
Intravenous infusion of efgartigimod - Biological Empasiprubart IV
Intravenous infusion of empasiprubart - Other Placebo IV
Intravenous infusion of placebo - Biological Efgartigimod PH20 SC PFS
Subcutaneous administration of Efgartigimod PH20 via pre-filled syringe (PFS)
Primary outcome measures
- 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 outcome measures (1)
- To evaluate the efficacy 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)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 14 centers
- Profound Research LLC - Carlsbad — Carlsbad
- Visionary Investigators Network — Miami
- Visionary Investigators Network — Miami
- University of South Florida — Tampa
- Erlanger Health System — Columbia
- Massachusetts General Hospital — Boston
- Henry Ford Health System — Detroit
- Dent Neurologic Institute - Amherst — Amherst
- … and 6 more centers
Italy · 4 centers
- ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII — Bergamo
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan
- AORN Antonio Cardarelli — Naples
Poland · 4 centers
- MICS Centrum Medyczne Bydgoszcz — Bydgoszcz
- Krakowska Akademia Neurologii Sp. z o.o. — Krakow
- Centrum Medyczne Neurologia Slaska — Katowice
- Warszawski Uniwersytet Medyczny — Warsaw
Greece · 2 centers
- Eginitio Hospital — Athens
- AHEPA University General Hospital of Thessaloniki — Thessaloniki
Spain · 2 centers
- Hospital Regional Universitario de Malaga - Hospital General — Málaga
- Hospital de La Santa Creu i Sant Pau — Barcelona
Belgium · 1 center
- UZ Leuven - PPDS — Leuven
Germany · 1 center
- Charité - Universitätsmedizin Berlin — Berlin
Japan · 1 center
- IUHW Narita Hospital — Narita
Identifiers
NCT: NCT07294170 · ARGX-999-2-MG-2000