TerminatedPhase 2

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

Stopped: 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.

United States33 participantsStarted 2023-06-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Number of Participants With TEAEs, TESAEs and TEAESIs

Timeframe: From the first dose of study drug (Day 1) up to 60 days post last dose of study drug, up to 383 days

Trial details

NCT IDNCT05918978

Sponsorargenx

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-15

Results submitted2025-08-15

View on ClinicalTrials.gov More Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome trials