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

NCT06298552 · ADAPT SERON Phase 3Active, not recruiting

Lead sponsor
argenx (Industry)
Enrollment
119 (actual)
Start date
16 Apr 2024
Primary completion
30 Jun 2025 (actual)
Study completion
1 Jun 2028
Last update posted
10 Aug 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Double
Arms
2

Interventions

  • Efgartigimod IV Biological
  • Placebo IV Other

Conditions and primary outcome

  • Generalized Myasthenia Gravis
  • gMG
  • Myasthenia Gravis, Generalized
  • Myasthenia Gravis

Primary outcome

MG-ADL Total Score Change From Baseline (Up to 29 days in part A)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT06298552 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

No primary outcome with a statistical analysis is posted for this study.

Serious adverse events

Time frame: Available data included for Part A (up to 8 weeks).

Participants with serious adverse events per group for ADAPT SERON, as posted
GroupAffectedAt risk
Efgartigimod IV358
Placebo161

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

No PubMed citation lists NCT06298552.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.