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

Primary Purpose

Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Efgartigimod
Sponsored by
argenx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome focused on measuring Tachycardia Post-COVID, Postural Orthostatic Tachycardia Syndrome efgartigimod

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • North Shore University HealthSystemRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Efgartigimod

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence and severity of AESIs.
adverse events of special interest

Secondary Outcome Measures

Change from baseline to week 24 and week 48 in COMPASS 31 (modified)
COMPASS 31 is a self-rated questionnaire with 31 questions in 6 domains
Change from baseline to week 24 and week 48 in MaPS
The MaPS questionnaire was developed specifically for patients with POTS by investigators at the Skåne University Hospital, Lund University in Malmö, Sweden. The 12-item evaluation score is being evaluated in a case-control study in patients with POTS compared to healthy controls.
Change from baseline to week 24 and week 48 in PGI-S
PGI-C at week 24 and week 48
Change from baseline to week 24 and 48 in the PROMIS Fatigue Short Form 8a
Change from baseline to week 24 and 48 in the PROMIS Cognitive Function Short Form 6a
Percent reduction from baseline in total IgG levels over the 48-week treatment period
Efgartigimod serum trough concentrations over the 48-week treatment period
Incidence of ADA against efgartigimod over the 48-week treatment period

Full Information

First Posted
June 22, 2023
Last Updated
June 22, 2023
Sponsor
argenx
Collaborators
Iqvia Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05918978
Brief Title
Open Label Extension of Efgartigimod in Adults With Post-COVID-19 POTS
Acronym
POTS
Official Title
Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of Efgartigimod in Adult Patients With Post-COVID-19 Postural Orthostatic Tachycardia Syndrome (PC-POTS) Who Completed Study ARGX-113-2104
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
argenx
Collaborators
Iqvia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome
Keywords
Tachycardia Post-COVID, Postural Orthostatic Tachycardia Syndrome efgartigimod

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Efgartigimod
Arm Type
Experimental
Arm Description
Receive efgartigimod IV 10mg/kg infusions during a treatment period of 48 weeks
Intervention Type
Drug
Intervention Name(s)
Efgartigimod
Intervention Description
Participants will receive efgartigimod IV 10 mg/kg open label, respectively.
Primary Outcome Measure Information:
Title
Incidence and severity of AESIs.
Description
adverse events of special interest
Time Frame
Up to 56 weeks
Secondary Outcome Measure Information:
Title
Change from baseline to week 24 and week 48 in COMPASS 31 (modified)
Description
COMPASS 31 is a self-rated questionnaire with 31 questions in 6 domains
Time Frame
Up to 48 weeks
Title
Change from baseline to week 24 and week 48 in MaPS
Description
The MaPS questionnaire was developed specifically for patients with POTS by investigators at the Skåne University Hospital, Lund University in Malmö, Sweden. The 12-item evaluation score is being evaluated in a case-control study in patients with POTS compared to healthy controls.
Time Frame
Up to 48 weeks
Title
Change from baseline to week 24 and week 48 in PGI-S
Time Frame
Up to 48 weeks
Title
PGI-C at week 24 and week 48
Time Frame
Up to 48 weeks
Title
Change from baseline to week 24 and 48 in the PROMIS Fatigue Short Form 8a
Time Frame
Up to 48 weeks
Title
Change from baseline to week 24 and 48 in the PROMIS Cognitive Function Short Form 6a
Time Frame
Up to 48 weeks
Title
Percent reduction from baseline in total IgG levels over the 48-week treatment period
Time Frame
Up to 48 weeks
Title
Efgartigimod serum trough concentrations over the 48-week treatment period
Time Frame
Up to 48 weeks
Title
Incidence of ADA against efgartigimod over the 48-week treatment period
Time Frame
Up to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Coppieters, MD
Phone
1-857-350-4834
Email
clinicaltrials@argenx.com
Facility Information:
Facility Name
North Shore University HealthSystem
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandru Barboi, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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