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

• Status: Active, not recruiting
• Trial end date: 2025-05-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: argenx
• Collaborator: Iqvia Pty Ltd

Criteria

Inclusion Criteria:

1. 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.

2. The participant signs the informed consent form, and can comply with OLE study (ARGX-113-2105) protocol requirements.

3. 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.

4. Female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP.

Exclusion Criteria:

1. 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.

2. The participant intends to become pregnant or start breastfeeding during the study.