Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Efgartigimod
Receive efgartigimod IV 10mg/kg infusions during a treatment period of 48 weeks
  • Drug: Efgartigimod
    Participants will receive efgartigimod IV 10 mg/kg open label, respectively.

Recruiting Locations

UC Sand Diego Sulpizio Cardiovascular Center
La Jolla, California 92037
Contact:
Erika Padilla

Standford Movement Disorder Center
Palo Alto, California 94304
Contact:
Brianna Heath

North Shore University HealthSystem
Glenview, Illinois 60026
Contact:
Alexandru Barboi, MD

Johns Hopkins University
Baltimore, Maryland 21205
Contact:
Stephen Cappello

Metrodora Institute
West Valley City, Utah 84119
Contact:
Vonda Page

More Details

NCT ID
NCT05918978
Status
Recruiting
Sponsor
argenx

Study Contact

Sabine Coppieters, MD
1-857-350-4834
clinicaltrials@argenx.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.