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

Last updated: December 2, 2024
Sponsor: argenx
Overall Status: Terminated

Phase

2

Condition

Heart Defect

Fast Heart Rate (Tachycardia)

Heart Disease

Treatment

Efgartigimod

Clinical Study ID

NCT05918978
ARGX-113-2105
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The participant has completed the ARGX-113-2104 study without permanentdiscontinuation of IMP and agrees to directly roll over into the extension studywithout 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 regulationsregarding 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 pregnancytest at baseline before receiving IMP.

Exclusion

Exclusion Criteria:

  1. The participant has a clinically significant condition, based on the judgement ofthe Study Investigator, eg, laboratory abnormalities, 12-lead ECG readings,concomitant medical disease(s), etc., which may place them at undue risk or confoundinterpretation of study data.

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

Study Design

Total Participants: 33
Treatment Group(s): 1
Primary Treatment: Efgartigimod
Phase: 2
Study Start date:
June 20, 2023
Estimated Completion Date:
August 15, 2024

Study 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.

Connect with a study center

  • UC Sand Diego Sulpizio Cardiovascular Center

    La Jolla, California 92037
    United States

    Site Not Available

  • Standford Movement Disorder Center

    Palo Alto, California 94304
    United States

    Site Not Available

  • North Shore University HealthSystem

    Glenview, Illinois 60026
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • University Hospitals, Neurology Clinical Trials

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Apex Trials Group

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Pioneer Clinical Research

    Rosharon, Texas 77583
    United States

    Site Not Available

  • Metrodora Institute

    West Valley City, Utah 84119
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.