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Trial record 1 of 1 for:    NCT05633407
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Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS (POTS)

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ClinicalTrials.gov Identifier: NCT05633407
Recruitment Status : Active, not recruiting
First Posted : December 1, 2022
Last Update Posted : January 3, 2024
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
argenx

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Postural Orthostatic Tachycardia Syndrome Drug: Efgartigimod Drug: Placebo Phase 2

Detailed Description:
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). Efgartigimod may be a viable treatment option for individuals diagnosed with post-COVID-19 POTS because it has been shown to reduce IgG levels, including IgG autoantibodies, which may underlie some of the autonomic disease manifestations in these patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Patients With Post-COVID-19 Postural Orthostatic Tachycardia Syndrome (POTS)
Actual Study Start Date : September 23, 2022
Estimated Primary Completion Date : June 7, 2024
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine


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

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





Primary Outcome Measures :
  1. Evaluate the efficacy of efgartigimod in reducing the severity of post-COVID-19 POTS symptoms [ Time Frame: Outcome measure is assessed at baseline and week 24. ]
    Change from baseline to week 24 in the Composite Autonomic Symptom Score 31 (COMPASS 31).

  2. Evaluate the efficacy of efgartigimod in reducing the severity of post-COVID-19 POTS symptoms [ Time Frame: Outcome measure is assessed at baseline and week 24. ]
    Change from baseline to week 24 in the Malmo POTS Symptom Score (MaPS).

  3. Evaluate the safety and tolerability of efgartigimod in patients with post-COVID-19 POTS [ Time Frame: Up to 31 weeks ]
    Incidence and severity of adverse events (AEs), incidence of serious adverse events (SAEs), changes in laboratory test results, vital sign measurements, and electrocardiogram (ECG) results.


Secondary Outcome Measures :
  1. Evaluate the efficacy of efgartigimod on patient global assessment of disease activity and fatigue [ Time Frame: Change from baseline to week 24 ]
    Change from baseline to week 24 in the Patient Global Impression of Severity (PGI-S)

  2. Evaluate the efficacy of efgartigimod on patient global assessment of disease activity and fatigue [ Time Frame: Change from baseline to week 24 ]
    Change from baseline to week 24 in the Patient Global Impression of Change (PGI-C)

  3. Evaluate the efficacy of efgartigimod on patient global assessment of disease activity and fatigue [ Time Frame: Change from baseline to week 24 ]
    Change from baseline to week 24 in the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a

  4. Evaluate the efficacy of efgartigimod on patient global assessment of disease activity and fatigue [ Time Frame: Change from baseline to week 24 ]
    Change from baseline to week 24 in the PROMIS Cognitive Function Short Form 6a

  5. Assess the pharmacodynamic (PD) effect of efgartigimod [ Time Frame: From Baseline to week 24 ]
    Absolute values, changes from baseline, and percent reduction from baseline in total IgG levels

  6. Assess the pharmacokinetic (PK) profile of efgartigimod [ Time Frame: From Baseline to week 24 ]
    Efgartigimod serum concentration-time profile

  7. Assess the immunogenicity of efgartigimod [ Time Frame: From Baseline to week 24 ]
    Incidence and prevalence of antidrug antibodies (ADA) against efgartigimod



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Reached the age of consent when signing the informed consent form
  2. Capable of providing signed informed consent and complying with protocol requirements
  3. Diagnosed with new-onset POTS post-COVID-19 established by the following:

    1. History of COVID-19 based on a previous positive test result from either laboratory-confirmed COVID-19 test (eg, a PCR test) or non-laboratory-confirmed COVID-19 test (eg, rapid antigen test); this positive result may be either documented or patient-reported
    2. Tilt table or orthostatic vital sign measurements during screening consistent with consensus criteria: sustained HR increase of ≥30 bpm within 10 min of standing or head up tilt (≥40 bpm for individuals aged 18 to 19 years) and/or HR reaching >120 bpm within 10 min; absence of sustained 20 mmHg decrease in systolic blood pressure (SBP)
    3. Ongoing symptoms of POTS confirmed by the investigator with at least 3 symptoms in each of the following areas lasting longer than 12 weeks after either diagnosis of COVID-19 or after hospital discharge for COVID-19:

    i. Vasomotor symptoms: fatigue, orthostatic intolerance, brain fog, exertional dyspnea, difficulty with concentration, venous pooling, and exercise intolerance ii. Sympathetic over-compensation symptoms: palpitation, heat intolerance, nausea with or without vomiting, insomnia, anxiety, lack of appetite, chest pain, and diaphoresis

  4. COMPASS 31 ≥35 at screening
  5. Agree to use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical studies and the following:

    Male participants Female participants of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before receiving IMP. Contraceptive requirements.

  6. Body mass index (BMI) <35 kg/m2

Exclusion Criteria:

  1. Diagnosis of or receiving treatment for the following conditions before COVID-19: peripheral neuropathy, POTS, myalgic encephalomyelitis encephalitis/chronic fatigue syndrome, Ehlers Danlos syndrome confirmed by genetic testing, autonomic neuropathy, multiple sclerosis, stroke, spinal cord injury, or any known lesions in the central nervous system by imaging or neurological exam
  2. History of or currently being treated for clinically significant ongoing cardiac arrythmia, heart failure, myocarditis, pulmonary embolism requiring anticoagulation, pulmonary fibrosis, or critical illness-related polyneuropathy or myopathy
  3. Known autoimmune disease that, in the investigator's judgment, would interfere with an accurate assessment of clinical symptoms of post-COVID-19 POTS or puts the participant at undue risk
  4. Known HIV disease or common variable immunodeficiency
  5. History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of IMP. Adequately-treated participants with the following cancers may be included at any time:

    1. Basal cell or squamous cell skin cancer
    2. Carcinoma in situ of the cervix
    3. Carcinoma in situ of the breast
    4. Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
  6. Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection or positive SARS-CoV-2 PCR test at screening
  7. Positive serum test at screening for an active infection with any of the following:

    1. Hepatitis B virus (HBV) that is indicative of an acute or chronic infection, unless associated with a negative HB surface antigen (HBsAg) or negative HBV DNA test
    2. Hepatitis C virus (HCV) based on HCV antibody assay unless a negative RNA test is available
    3. HIV
  8. A medical condition that could confound the results of the study or put the participant at undue risk in the investigator's judgment
  9. Clinically significant disease, recent major surgery (within 3 months of screening), or intends to have surgery during the study; or any other condition that in the opinion of the investigator could confound the results of the study or put the participant at undue risk
  10. Total IgG <4 g/L at screening
  11. Received within 12 weeks or 5 half-lives (whichever is longer) before screening an investigational product
  12. Received within 12 weeks before screening either intravenous immunoglobulin (Ig) IV or SC or plasmapheresis/plasma exchange (PLEX)
  13. Received a live or live-attenuated vaccine less than 4 weeks before screening
  14. Known hypersensitivity to IMP or 1 of its excipients
  15. Previously participated in an efgartigimod clinical study and received at least 1 dose of IMP
  16. Currently participating in another interventional clinical study
  17. History (within 12 months of screening) of or current alcohol, drug, or medication abuse
  18. Pregnant or lactating or intends to become pregnant during the study
  19. Unwilling to remain on a stable regimen of medications during the study
  20. Unwilling to avoid initiation of new physical rehabilitation or other physician-prescribed exercise programs during the 24-week treatment period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05633407


Locations
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United States, California
University of California, San Diego Sulpizio Cardiovascular Center
La Jolla, California, United States, 92037
Stanford Movement Disorder Center
Palo Alto, California, United States, 94304
United States, Illinois
Northshore University Health System
Glenview, Illinois, United States, 60026
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Harvard Medical School, Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Tennessee
Vandetbilt University Medical Center / Clinical Research Center
Nashville, Tennessee, United States, 37232
United States, Texas
Apex Trials Croup, LLC
Fort Worth, Texas, United States, 76132
Texas Institute of Cardiology
McKinney, Texas, United States, 75071
Pioneer Clinical Research
Rosharon, Texas, United States, 77583
United States, Utah
Metrodora Institute
West Valley City, Utah, United States, 84119
Sponsors and Collaborators
argenx
Iqvia Pty Ltd
Additional Information:
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Responsible Party: argenx
ClinicalTrials.gov Identifier: NCT05633407    
Other Study ID Numbers: ARGX-113-2104
First Posted: December 1, 2022    Key Record Dates
Last Update Posted: January 3, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by argenx:
POTS
Long COVID
Postural Orthostatic Tachycardia Syndrome
efgartigimod
Additional relevant MeSH terms:
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Postural Orthostatic Tachycardia Syndrome
Tachycardia
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases