Open Label Extension of Efgartigimod in Adults With Post-COVID-19 POTS

Stopped early · Phase 2

Conditions studied: Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome

In brief

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.

Key facts

Study ID

NCT05918978

Run by

argenx

People needed

33

Starts

2023-06-20

Expected to finish

2024-08-15

Last updated by the study team

2025-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UC Sand Diego Sulpizio Cardiovascular Center — La Jolla, California, United States
• Standford Movement Disorder Center — Palo Alto, California, United States
• North Shore University HealthSystem — Glenview, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University Hospitals, Neurology Clinical Trials — Cleveland, Ohio, United States
• Apex Trials Group — Fort Worth, Texas, United States
• Pioneer Clinical Research — Rosharon, Texas, United States
• Metrodora Institute — West Valley City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.