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

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argenx

Status and phase

Active, not recruiting
Phase 2

Conditions

Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome

Treatments

Drug: Efgartigimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT05918978
ARGX-113-2105

Details and patient eligibility

About

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.

Full description

Study ARGX-113-2105 is a long-term, single-arm, open-label, multicenter extension of the ARGX-113-2104 study, designed to evaluate the long-term safety of efgartigimod IV in adult patients with PC-POTS. Participants will be enrolled from both active and placebo arms of the ARGX-113-2104 study and will receive efgartigimod IV 10 mg/kg in the extension study without knowledge of their prior treatment arm. To be eligible to enroll in this study, participants must have completed the 24-week treatment period of the ARGX-113-2104 study and must not have permanently discontinued the IMP in that study.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

33 participants in 1 patient group

Efgartigimod
Experimental group
Description:
Receive efgartigimod IV 10mg/kg infusions during a treatment period of 48 weeks
Treatment:
Drug: Efgartigimod

Trial contacts and locations

9

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Central trial contact

Sabine Coppieters, MD

Data sourced from clinicaltrials.gov

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