Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS

Part of paid clinical trials in La Jolla, California.

Sponsor
argenx
Study ID
NCT05633407
Phase
PHASE2
Status
Completed

Conditions

  • Postural Orthostatic Tachycardia Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod — DRUG
    Efgartigimod IV 10 mg/kg infusion qw for 24 weeks. Participants will be randomized to receive efgartigimod IV 10 mg/kg or matching placebo in a 2:1 ratio, respectively
  • Placebo — DRUG
    Receive a matching placebo during weekly infusions during a treatment period of 24 weeks. Participants will be randomized to receive efgartigimod IV 10 mg/kg or matching placebo in a 2:1 ratio, respectively

Study Details

The study aims to investigate the safety, tolerability, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod compared to placebo in participants with post-COVID-19 postural orthostatic tachycardia syndrome (POTS) (post-COVID-19 POTS).

Key Dates

Start date
Sep 23, 2022
Status verified
May 2025
Primary completion
Apr 18, 2024
Completion
Apr 18, 2024

Study Design

Enrollment
53 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Efgartigimod
    Receive efgartigimod IV 10mg/kg during weekly infusions during a treatment period of 24 weeks
  • Placebo Comparator: Placebo
    Receive a matching placebo during weekly infusions during a treatment period of 24 weeks

Primary Outcome Measure

Change From Baseline to Week 24 in the COMPASS 31 (2-week Recall Version) [ Time Frame: Baseline (Day 1) and Week 24 ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of California, San Diego Sulpizio Cardiovascular CenterLa JollaCalifornia92037-
Stanford Movement Disorder CenterPalo AltoCalifornia94304-
Northshore University Health SystemGlenviewIllinois60026-
Johns Hopkins UniversityBaltimoreMaryland21224-
Harvard Medical School, Brigham and Women's HospitalBostonMassachusetts02115-
Case Western Reserve UniversityClevelandOhio44106-
Vandetbilt University Medical Center / Clinical Research CenterNashvilleTennessee37232-
Apex Trials Croup, LLCFort WorthTexas76132-
Texas Institute of CardiologyMcKinneyTexas75071-
Pioneer Clinical ResearchRosharonTexas77583-
Metrodora InstituteWest Valley CityUtah84119-

Find similar trials in La Jolla, CA

By research site
University of California, San Diego Sulpizio Cardiovascular Center· La Jolla, CAStanford Movement Disorder Center· Palo Alto, CANorthshore University Health System· Glenview, ILJohns Hopkins University· Baltimore, MDHarvard Medical School, Brigham and Women's Hospital· Boston, MACase Western Reserve University· Cleveland, OH

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