Myasthenia GravisNCT07294170
ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
An observational study of Myasthenia Gravis and MG, run by argenx at 37 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis, MG, gMG
- What is being tested?
- Efgartigimod IV, Empasiprubart IV and Efgartigimod PH20 SC PFS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 37 sitesin 8 countries
- Study dates
- 19 Dec 2025to 7 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
37 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
37 sites in 8 countries
United States15 sites, 15 recruiting
- Recruiting
Dent Neurologic Institute - Amherst
Amherst, New York, 14226
Luisa Rojas Estupinan, MD, 716-250-2000, aemborsky@dentinstitute.com
- Recruiting
National Neuromuscular Research Institute
Austin, Texas, 78759
Yessar Hussain, MD, 512-920-0140, marisol@austinneuromuscle.com
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114-2621
Amanda Guidon, MD, 617-726-3642, aguidon@mgb.org
- Recruiting
Profound Research LLC - Carlsbad
Carlsbad, California, 92011
Gregory Sahagian, MD, 760-732-0557, lupe@profoundresearch.com
- Recruiting
University of North Carolina at Chapel Hill-170 Manning Dr.
Chapel Hill, North Carolina, 27514-4221
James Howard, MD, +1 857-350-4834, howardj@neurology.unc.edu
- Recruiting
Erlanger Health System
Chattanooga, Tennessee, 37403-2136
Joshua Alpers, MD, 423-778-3900, joshua.alpers@erlanger.org
- Recruiting
University of Cincinnati Medical Center - Goodman St
Cincinnati, Ohio, 45219=2364
Hani Kushlaf, (513) 558-0269, kushlaha@ucmail.uc.edu
- Recruiting
Ohio State Martha Morehouse Outpatient Care
Columbus, Ohio, 43221-3502
Miriam Freimer, MD, 614-293-4969, Mariam.Freimer@osumc.edu
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202-2608
Kavita Grover, MD, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Duke Early Phase Clinical Research Unit - PPDS
Durham, North Carolina, 27710-0001
Vern Juel, MD, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Profound Research LLC at Las Vegas Neurology Center
Las Vegas, Nevada, 89106
Paul Janda, MD, +1 857-350-4834, Paul.Janda@profoundresearch.com
- Recruiting
Visionary Investigators Network
Miami, Florida, 33133
Andrew Lerman, MD, 786-655-8010, alerman@fcneurology.net
- Recruiting
Visionary Investigators Network
Miami, Florida, 33180
Andrew Lerman, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
University of Texas- San Antonio - Health Science Center - PPDS
San Antonio, Texas, 78229
Ratna Bhavaraju-Sanka, MD, 210-567-8229, BhavarajuSan@uthscsa.edu
- Recruiting
University of South Florida
Tampa, Florida, 33620
Tuan Vu, MD, (813) 974-9413, tvu6@usf.edu
Japan5 sites, 5 recruiting
- Recruiting
General Hanamaki Hospital - Kajomachi
Hanamaki, 025-0075
Kimiaki Utsugisawa, MD, kutsugisawa@gmail.com
- Recruiting
St. Marianna University Hospital
Kawasaki-Shi, Kanagawa, 216-8511
Kenzo Sakurai, MD, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
IUHW Narita Hospital
Narita, 286-8520
Hiroyuki Murai, MD, murai@iuhw.ac.jp
- Recruiting
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, 983-0045
Yasushi Suzuki, MD, +1 857-350-4834, ysuzuki_snh@yahoo.co.jp
- Recruiting
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576
Shinji Saiki, MD, +1 857-350-4834, ssaiki@md.tsukuba.ac.jp
Italy4 sites, 4 recruiting
- Recruiting
ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
Bergamo, Lombardy, 24127
Giorgia Camera, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, 20133
Carlo Antozzi, MD, +1 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133
Carlo Antozzi, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
AORN Antonio Cardarelli
Naples, 80131
Francesco Habetswallner, MD, francesco.habetswallner@aocardarelli.it
Poland4 sites, 4 recruiting
- Recruiting
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-065
Lukasz Rzepinski, MD, +48523401414, lukasz.rzepinski@mics.medicover.com
- Recruiting
Centrum Medyczne Neurologia Slaska
Katowice, Silesian Voivodeship, 40-689
Marek Smilowski, MD, +48500282494, marek.smilowski@neurologiaslaska.pl
- Recruiting
Krakowska Akademia Neurologii Sp. z o.o.
Krakow, Lesser Poland Voivodeship, 31-505
Andrzej Szczudlik, MD, +48602628121, andrzej.szczudlik@neurologia.org.pl
- Recruiting
Warszawski Uniwersytet Medyczny
Warsaw, 00-665
Anna Kostera-Pruszczyk, MD, +48 22 599 2858, anna.kostera-pruszczyk@wum.edu.pl
Germany3 sites, 3 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 13353
Sarah Hoffmann, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Universitätsmedizin Göttingen
Göttingen, 37075
Jana Zschuentzsch, MD, +49 551 39 67273, j.zschuentzsch@med.uni-goettingen.de
- Recruiting
Universitätsklinikum Würzburg
Würzburg, 97080
Axel Haarmann, MD, +4993120123595, haarmann_a@ukw.de
Belgium2 sites, 2 recruiting
- Recruiting
UZ Leuven - PPDS
Leuven, 3000
Kristl Claeys, MD, +3216344278, kristi.claeys@uzleuven.be
- Recruiting
Hôpital de la Citadelle
Liège, 4000
Margaux Poleur, +1 857-350-4834, margaux.poleur@citadelle.be
Greece2 sites, 2 recruiting
- Recruiting
Eginitio Hospital
Athens, 115 28
Vasiliki Zouvelou, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
AHEPA University General Hospital of Thessaloniki
Thessaloniki, 546 36
Marianthi Arnaoutoglou, MD, 857-350-4834, clinicaltrials@argenx.com
Spain2 sites, 2 recruiting
- Recruiting
Hospital de La Santa Creu i Sant Pau
Barcelona, 8041
Elena Cortes Vicente, MD, +34935537115, ecortes@santpau.cat
- Recruiting
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Malaga, 340120
Guillermina García Martín, MD, +1 857-350-4834, clinicaltrials@argenx.com
About this study
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
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.
Read the 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
- Conditions
- Myasthenia Gravis, MG, gMG, Generalized Myasthenia Gravis, Generalized Myasthenia Gravis (gMG), AChR-Ab Seropositive Generalized Myasthenia Gravis
- Being tested
- Efgartigimod IV, Empasiprubart IV, Placebo IV, Efgartigimod PH20 SC PFS
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efgartigimod IVBiological
Intravenous infusion of efgartigimod
Empasiprubart IVBiological
Intravenous infusion of empasiprubart
Placebo IVOther
Intravenous infusion of placebo
Efgartigimod PH20 SC PFSBiological
Subcutaneous administration of Efgartigimod PH20 via pre-filled syringe (PFS)
| Study group | Role | What they receive |
|---|---|---|
| ISA1 participants | Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod Receives: Biological: Efgartigimod IV; Biological: Empasiprubart IV | |
| ISA2 participants | Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis Receives: Biological: Empasiprubart IV; Other: Placebo IV; Biological: Efgartigimod PH20 SC PFS |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes
Measured: 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
Measured: Up to approximately 7 years (the duration of each ISA will vary and be specified on the ISA records)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start19 Dec 2025
- Primary completion7 Mar 2028 (estimated)
- Study completion7 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294170
- Sponsor's protocol ID
- ARGX-999-2-MG-2000
- Status last verified
- Sep 2026
- First submitted
- 8 Dec 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07294170
- Acronym / sponsor ID
- ARGX-999-2-MG-2000
- Conditions
- Myasthenia Gravis, MG, gMG, Generalized Myasthenia Gravis, Generalized Myasthenia Gravis (gMG), AChR-Ab Seropositive Generalized Myasthenia Gravis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 7 Mar 2028 (estimated)
- Study completion
- 7 Mar 2028 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISA1 participants | – | Biological: Efgartigimod IV, Biological: Empasiprubart IVParticipants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod |
| ISA2 participants | – | Biological: Empasiprubart IV, Other: Placebo IV, Biological: Efgartigimod PH20 SC PFSParticipants With AChR-Ab Seropositive Generalized Myasthenia Gravis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efgartigimod IVIntravenous infusion of efgartigimod | Biological | ISA1 participants |
| Empasiprubart IVIntravenous infusion of empasiprubart | Biological | ISA1 participants, ISA2 participants |
| Placebo IVIntravenous infusion of placebo | Other | ISA2 participants |
| Efgartigimod PH20 SC PFSSubcutaneous administration of Efgartigimod PH20 via pre-filled syringe (PFS) | Biological | ISA2 participants |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
37 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis and MG, run by argenx at 37 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Japan, Italy, Poland, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Coppieters, MD (857-350-4834, clinicaltrials@argenx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.