WHO ICTRP trial
A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the…
NL-OMON51130 · Overview of Medical Research in the Netherlands (NL-OMON) · Not Recruiting
Key facts
| Trial ID | NL-OMON51130 |
|---|---|
| Public title | A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) |
| Scientific title | A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized… |
| Primary sponsor | argenx BV |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | 3 |
| Countries | Belgium;Bosnia and Herzegovina;Czechia;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation ;Serbia;Spain;United Kingdom;United States of America |
| Conditions | Disease of the neuro muscular junction; Serious muscle weakness;10003816;10029317;Disease of the neuro muscular junction; Serious muscle weakness |
| Interventions | Patients will be randomized in a 1:1 ratio to receive either efgartigimod PH20 SC 1000 mg or efgartigimod IV 10 mg/kg in addition to their concomitant gMG therapy. Efgartigimod PH20 SC or efgartigimod IV is administered weekly for a total… |
| Registration date | Jan 31, 2022 |
| Target size | 2 |
| Secondary IDs | 2020-004085-19;NCT04735432;NL76174.058.20 |
| Registry page | onderzoekmetmensen.nl |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: