Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis
NCT04818671 · ADAPTSC+ Phase 3Completed
- Lead sponsor
- argenx (Industry)
- Enrollment
- 184 (actual)
- Start date
- 26 Apr 2021
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024
- Last update posted
- 22 Jan 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None
- Arms
- 1
Interventions
- efgartigimod PH20 SC Biological
Conditions and primary outcome
- Generalized Myasthenia Gravis
Primary outcome
Number of AEs, SAEs and AESIs (Up to 3.5 years)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT04818671 (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: 3.5 years
| Group | Affected | At risk |
|---|---|---|
| Efgartigimod PH20 SC | 55 | 180 |
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
2 on PubMedLong-term safety, tolerability, and efficacy of subcutaneous efgartigimod PH20 in generalized myasthenia gravis: final results from a phase 3 open-label extension study (ADAPT-SC+).
Frontiers in neurology · 2026
PubMed 42699831 (opens in a new tab)DOI 10.3389/fneur.2026.1876344 (opens in a new tab)
Subcutaneous efgartigimod PH20 in generalized myasthenia gravis: A phase 3 randomized noninferiority study (ADAPT-SC) and interim analyses of a long-term open-label extension study (ADAPT-SC+).
Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2024 Sep
PubMed 39227284 (opens in a new tab)DOI 10.1016/j.neurot.2024.e00378 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04818671 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
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.