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A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

Study acronym: ADAPT SERON
StatusActive, Not Recruiting
PhasePhase 3
Sponsorargenx
Started2024-04-16
View on ClinicalTrials.gov ↗

Amendment history

2026-08-06
Study Status, Participant Flow v15
Completion pushed: 2027-06 → 2028-06
Results first postednot stated→2026-08-10
2026-06-30
Study Status, Study Description, Outcome Measures, Eligibility, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats, More Information v14
Completion date2027-06→2028-06
Eligibility criteriarevised
[...] lectromyography or repetitive nerve stimulation (RNS) or is for anti-muscle-specific kinase antibodies (MuSK-Ab) seropositiv [...] nt is receiving a stable dose of MG therapy before screening, that includesincluding acetylcholinesterase (AChE) inhibitors, steroids, or nonste [...] immunosuppressive therapies (NSISTs) in combination or alone. Exclusion Criteria: Known autoimmune disease or any medical [...]
Secondary endpoints11 to 10 entries
QMG totalTotal scoreScore changeChange fromFrom baselineBaseline Proportion of participantsParticipants whoWho areAre bothBoth MG-ADL and QMG respondersResponders in partPart A Proportion of participantsParticipants withWith MSE Proportion of participantsParticipants whoWho areAre MG-ADL respondersResponders in partPart A Proportion of participantsParticipants whoWho areAre QMG respondersResponders in partPart A Proportion of participantsParticipants whoWho areAre earlyEarly MG-ADL respondersResponders in partPart A MG-ADL totalTotal scoreScore changeChange fromFrom baselineBaseline overOver t [...] [...]
Primary endpoints1 entry, revised
MG-ADL totalTotal scoreScore changeChange fromFrom baselineBaseline
2025-11-04
Study Status, Oversight, Conditions, Outcome Measures, IPDSharing v13
Primary completion dateestimated 2025-07-25→confirmed 2025-06-30
Completion date2027-07-23→2027-06
Secondary endpoints2 to 11 entries
Quantitative myasthenia gravis (QMG) total score change from baseline Proportion of participants who are both MG-ADL and QMG responders in part A Proportion of participants with MSE Proportion of participants who are MG-ADL responders in part A Proportion of participants who are QMG responders in part A Proportion of participants who are early MG-ADL responders in part A MG-ADL total score change from baseline over time in part A a [...]
Primary endpoints1 entry, revised
Myasthenia Gravis Activities of Daily Living (MG-ADL) total score change from baseline
2025-06-11
Recruiting→Active, Not Recruiting Study Status, Study Description, Study Design, Eligibility, Contacts/Locations v12
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 110→confirmed 119
Eligibility criteria-341 characters
[...] wing: Hepatitis B virus (HBV), Hepatitis C virus (HCV), HIV Current participation in another interventional clinical study or previous participation in an efgartigimod clinical study and received at least 1 dose of the study drug Known hypersensitivity to study drug or one of its excipients (inactive ingredients) History of or current alcohol, drug, or medication abuse as [...] before screening or thymectomy is planned during the study Use of some medications before screening (more information is found in the protocol). The complete list of exclusion criteria can be found in the protocol.
Study sitesdetails revised at 91 of 91 sites
2025-05-02
Study Identification, Study Status, Contacts/Locations v11
Study sites89→91
Study titlerevised
A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients withWith Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
Show 10 earlier versions
2025-02-20
Study Status, Contacts/Locations v10
Study sites78→89
2025-01-16
Study Status, Contacts/Locations v9
Study sites58→78
2024-12-12
Study Status, Contacts/Locations v8
Study sites37→58
2024-11-06
Study Status, Contacts/Locations, References v7
Study sites30→37
2024-09-26
Study Identification, Study Status, Oversight, Eligibility, Contacts/Locations, IPDSharing v6
Study sites26→30
Eligibility criteria+239 characters
Inclusion Criteria: The participant is at least 18 years of age and the local legal age of consent for clinical studies when si [...] obulin (IVIg)/ subcutaneous immunoglobulin (SCIg) treatment The participant is receiving a stable dose of MG therapy before screening that includes acetylcholinesterase (AChE) inhibitors, steroids, or nonsteroidal immunosuppressive therapies (NSISTs) in combination or alone. Exclusion Criteria: Known autoimmune disease or any medical [...] t during the study Live or live-attenuated vaccine received <&lt;4 weeks before screening Worsening muscle weakness secondary [...]
Study titlerevised
A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients Withwith Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
2024-07-23
Study Status, Contacts/Locations v5
Study sites24→26
2024-06-17
Study Status, Contacts/Locations v4
Study sites20→24
2024-05-21
Study Status, Contacts/Locations v3
Study sites1→20
2024-05-08
Study Status, Eligibility v2
Re-verified, no change to tracked fields
2024-04-22
Not Yet Recruiting→Recruiting Study Identification, Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-04→confirmed 2024-04-16
Study sites0→1
Secondary endpointsdetails revised at 1 of 2 entries
2024-03-01
Original filing
Argenx
56 trials monitored
See 2 trials at risk
Myasthenia Gravis
187 trials monitored
See 7 trials at risk
The primary purpose of this study is to measure the efficacy and safety of efgartigimod IV compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). The study consists of a Part A where participants will be randomized to receive either efgartigimod IV or placebo IV and a Part B where participants completing part A will receive open-label efgartigimod IV. Participants will be in the study for up to (approximately) 3.5 years.
Trial Details
NCT Number NCT06298552
Lead Sponsor argenx
Conditions Generalized Myasthenia Gravis, gMG, Myasthenia Gravis, Generalized, Myasthenia Gravis
Enrollment 119 participants
Start Date 2024-04-16
Primary Completion 2025-06-30 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-10