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

NCT05918978 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: ARGX-113-2105
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome

Keywords

Tachycardia Post-COVID; Postural Orthostatic Tachycardia Syndrome efgartigimod

Outcome Measures

Primary Outcomes (1)

• Number of Participants With TEAEs, TESAEs and TEAESIs

  An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other medically important event. An adverse event of special interest (AESI) was an AE of scientific and medical concern specific to the sponsor's product or program. Treatment-emergent adverse events (TEAEs) were defined as AEs with onset on or after the first administration of study drug up to and including 60 days after the last study drug administration.

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

Secondary Outcomes (9)

• Change From Baseline to Weeks 24 and 48 in the COMPASS 31 (2-week Recall Version)

  Baseline (Day 1) and Weeks 24 and 48

• Change From Baseline to Weeks 24 and 48 in the MaPS

  Baseline (Day 1) and Weeks 24 and 48

• Percentage of Participants With Improved PGI-S at Weeks 24 and 48

  Baseline (Day 1) and Weeks 24 and 48

• Percentage of Participants With Improved PGI-C at Weeks 24 and 48

  Baseline (Day 1) and Weeks 24 and 48

• Change From Baseline to Weeks 24 and 48 in the PROMIS Fatigue Short Form 8a

  Baseline (Day 1) and Weeks 24 and 48

Study Arms (1)

Efgartigimod

EXPERIMENTAL

Receive efgartigimod IV 10mg/kg infusions during a treatment period of 48 weeks

Drug: Efgartigimod

Interventions

Efgartigimod DRUG

Participants will receive efgartigimod IV 10 mg/kg open label, respectively.

Efgartigimod

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• argenx: lead
• Iqvia Pty Ltd: collaborator

Study Sites (9)

UC Sand Diego Sulpizio Cardiovascular Center

La Jolla, California, 92037, United States

Location

Standford Movement Disorder Center

Palo Alto, California, 94304, United States

Location

North Shore University HealthSystem

Glenview, Illinois, 60026, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University Hospitals, Neurology Clinical Trials

Cleveland, Ohio, 44106, United States

Location

Apex Trials Group

Fort Worth, Texas, 76104, United States

Location

Pioneer Clinical Research

Rosharon, Texas, 77583, United States

Location

Metrodora Institute

West Valley City, Utah, 84119, United States

Location

MeSH Terms

Interventions

efgartigimod alfa

Limitations and Caveats

This study was terminated not for safety concerns but because the parent study found that efgartigimod IV provided no efficacy benefit in adult participants with PC-POTS.

Results Point of Contact

• Title: Regulatory Manager
• Organization: argenx BVBA

regulatory@argenx.com

+32 93103400

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: June 26, 2023
• Study Start: June 20, 2023
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: October 23, 2025
• Results First Posted: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)