Open Label Extension of Efgartigimod in Adults With Post-COVID-19 POTS
Megadott ok: Due to the phase 2 results of the main study (ARGX-113-2104) showing that efgartigimod-treated PC-POTS patients had no clinically meaningful improvement, the decision has been made to terminate this open-label extension study (ARGX-113-2105) study.
A legfontosabb adatok
- Hol
- Baltimore, Boston, Cleveland, Fort Worth, Glenview, La Jolla, Palo Alto, Rosharon és West Valley City (Egyesült Államok)Mind a 9 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Johns Hopkins UniversityBaltimore, Egyesült ÁllamokNo longer taking part
- Brigham and Women's HospitalBoston, Egyesült ÁllamokNo longer taking part
- University Hospitals, Neurology Clinical TrialsCleveland, Egyesült ÁllamokNo longer taking part
- Apex Trials GroupFort Worth, Egyesült ÁllamokNo longer taking part
- North Shore University HealthSystemGlenview, Egyesült ÁllamokNo longer taking part
- UC Sand Diego Sulpizio Cardiovascular CenterLa Jolla, Egyesült ÁllamokNo longer taking part
- Standford Movement Disorder CenterPalo Alto, Egyesült ÁllamokNo longer taking part
- Pioneer Clinical ResearchRosharon, Egyesült ÁllamokNo longer taking part
- Metrodora InstituteWest Valley City, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- argenx
- Azonosító
- NCT05918978
- A regiszteradat frissítve
- 2025. október 23.
- Eredeti leírás
The OLE study aims to investigate the safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod in participants with post-COVID-19 postural orthostatic.A teljes eredeti leírásKevesebb
Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of Efgartigimod in Adult Patients With Post-COVID-19 Postural Orthostatic Tachycardia Syndrome (PC-POTS) Who Completed Study ARGX-113-2104
The OLE study aims to investigate the safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod in participants with post-COVID-19 postural orthostatic.
Bevonási feltételek: The participant has completed the ARGX-113-2104 study without permanent discontinuation of IMP and agrees to directly roll over into the extension study without discontinuation of IMP; The participant signs the informed consent form, and can comply with OLE study (ARGX-113-2105) protocol requirements; The participant agrees to use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Contraceptive requirements are provided; Female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP.
Kizáró feltételek: The participant has a clinically significant condition, based on the judgement of the Study Investigator, eg, laboratory abnormalities, 12-lead ECG readings, concomitant medical disease(s), etc., which may place them at undue risk or confound interpretation of study data; The participant intends to become pregnant or start breastfeeding during the study.