Efgartigimod for Post-COVID POTS

(POTS Trial)

No longer recruiting at 10 trial locations

Overseen By Sabine s Coppieters, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: argenx

Must not be taking: Anticoagulants, Immunoglobulins

Disqualifiers: Peripheral neuropathy, Cardiac arrhythmia, Autoimmune disease, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 24

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of efgartigimod, an experimental treatment for post-COVID-19 postural orthostatic tachycardia syndrome (POTS). POTS causes an increased heart rate upon standing, leading to symptoms like dizziness and fatigue. Participants will receive either efgartigimod or a placebo to compare outcomes. Individuals who developed POTS after recovering from COVID-19 and experience ongoing symptoms such as fatigue, brain fog, and palpitations may be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial requires participants to stay on a stable regimen of medications during the study, so you should not stop taking your current medications.

Is there any evidence suggesting that efgartigimod is likely to be safe for humans?

Research shows that efgartigimod is being tested for safety in people with post-COVID-19 postural orthostatic tachycardia syndrome (POTS). In earlier studies, researchers tried efgartigimod for other conditions. Although specific safety information for post-COVID POTS is still being collected, these studies have found no major safety issues, suggesting that efgartigimod is generally well-tolerated. However, its safety for this specific use in POTS is still under investigation. As efgartigimod is in phase 2 of trials, researchers are closely examining its safety and side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for POTS?

Unlike the standard treatments for Postural Orthostatic Tachycardia Syndrome (POTS), which usually involve lifestyle adjustments, medications like beta-blockers, or increased salt and fluid intake, efgartigimod offers a new approach by targeting the immune system. Efgartigimod is unique because it works by reducing autoantibodies through its action on the neonatal Fc receptor (FcRn). Researchers are excited about this treatment because it has the potential to address an underlying cause of POTS in some patients, especially those with an autoimmune component, rather than just managing symptoms. This could lead to more effective and long-lasting improvements for individuals suffering from post-COVID POTS.

What evidence suggests that efgartigimod might be an effective treatment for post-COVID POTS?

In this trial, participants will receive either efgartigimod or a placebo. Research suggests that efgartigimod might help treat post-COVID-19 POTS by lowering levels of IgG, a type of antibody. This decrease may calm the immune system, which can be overactive in some POTS patients. However, a previous study showed that patients with post-COVID-19 POTS did not experience significant improvement when treated with efgartigimod. While the theory suggests possible benefits, current evidence for its effectiveness in treating this specific condition remains limited. More research is needed to better understand its effects. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults who developed Postural Orthostatic Tachycardia Syndrome (POTS) after having COVID-19 can join this trial. They must have a BMI under 35, be able to follow the study rules, and use birth control as required. People with certain pre-existing conditions, ongoing serious infections or diseases like HIV or cancer in the last 3 years, recent major surgery, drug abuse history, or those pregnant cannot participate.

Inclusion Criteria

Capable of providing signed informed consent and complying with protocol requirements

I am of legal age to make my own health decisions.

You weigh less than a certain amount for your height.

Exclusion Criteria

You have a positive blood test for a specific virus that is causing an active infection.

You have certain medical conditions, had recent major surgery, used investigational products or live vaccines, are allergic to the study drug, participated in a previous efgartigimod study, are currently in another study, have a history of substance abuse, are pregnant, or are not willing to stay on a consistent medication routine or avoid new exercise programs.

I have not had autoimmune diseases, HIV, immunodeficiency, or cancer in the last 3 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly infusions of efgartigimod or placebo for 24 weeks

24 weeks

24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Efgartigimod
• Placebo

Trial Overview The trial is testing Efgartigimod against a placebo to see if it's safe and effective for treating POTS symptoms that started after COVID-19. It will also look at how the body processes the drug and its impact on immune system responses.

How Is the Trial Designed?

Group I: Efgartigimod Experimental Treatment 1 Intervention

Receive efgartigimod IV 10mg/kg during weekly infusions during a treatment period of 24 weeks

Group II: Placebo Placebo Group 1 Intervention

Receive a matching placebo during weekly infusions during a treatment period of 24 weeks

Efgartigimod is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Vyvgart for:

• Generalized Myasthenia Gravis (gMG)

Approved in United States as Vyvgart for:

• Generalized Myasthenia Gravis (gMG)
• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Approved in Canada as Vyvgart for:

• Generalized Myasthenia Gravis (gMG)

Approved in Japan as Vyvgart for:

• Generalized Myasthenia Gravis (gMG)

Who Is Running the Clinical Trial?

argenx

Lead Sponsor

Trials

76

Recruited

11,500+

Tim Van Hauwermeiren

argenx

Chief Executive Officer since 2008

B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management

Dr. Peter Ulrichts

argenx

Chief Medical Officer since 2023

MD from Maastricht University, PhD in Molecular Immunology from Maastricht University

Iqvia Pty Ltd

Industry Sponsor

Trials

120

Recruited

177,000+

Ari Bousbib

Iqvia Pty Ltd

Chief Executive Officer since 2016

MBA from Columbia University, Master of Science in Mathematics and Mechanical Engineering from Ecole Superieure des Travaux Publics, Paris

Jeffrey Spaeder

Iqvia Pty Ltd

Chief Medical Officer

MD

Published Research Related to This Trial

Pegfilgrastim is as effective or even more effective than filgrastim in reducing chemotherapy-induced neutropenia, making it a strong option for patients undergoing cancer treatment.

One of the key benefits of pegfilgrastim is that it can be administered just once per chemotherapy cycle, which may improve patient compliance and enhance their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pegfilgrastim; a neutrophil mediated granulocyte colony stimulating factor-expanding uses in cancer chemotherapy. Morishita, M., Leonard, RC.[2022]

Mecapegfilgrastim, a long-acting granulocyte colony-stimulating factor, significantly reduced the duration of severe neutropenia in breast cancer patients undergoing chemotherapy compared to filgrastim, with mean durations of 1.06 days and 2.06 days respectively.

Both dosing regimens of mecapegfilgrastim (100 µg/kg and a fixed 6 mg dose) were well tolerated and showed comparable efficacy, making the fixed 6 mg dose a convenient option for patients due to its once-per-cycle administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of mecapegfilgrastim for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer: a randomized, multicenter, active-controlled phase III trial. Xu, F., Zhang, Y., Miao, Z., et al.[2022]

Postural orthostatic tachycardia syndrome (POTS) can develop in 2%-14% of COVID-19 survivors, with many experiencing symptoms like tachycardia and fatigue for up to 6-8 months after infection, indicating a significant long-term impact of COVID-19 on autonomic function.

Management of post-COVID-19 POTS may involve lifestyle changes and medications such as ivabradine or β-blockers, highlighting the need for a multidisciplinary approach to care, as well as further research to understand its mechanisms and improve treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postural orthostatic tachycardia syndrome as a sequela of COVID-19. Ormiston, CK., Świątkiewicz, I., Taub, PR.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05918978

Open Label Extension of Efgartigimod in Adults With Post- ... Due to the phase 2 results of the main study (ARGX-113-2104) showing that efgartigimod-treated PC-POTS patients had no clinically meaningful improvement, the ...

2. hopkinsmedicine.org hopkinsmedicine.org/clinical-trials/results/irb00393353

Clinical Trials Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of Efgartigimod in Adult Patients with Post-COVID-19 Postural Orthostatic Tachycardia ...

3. ctv.veeva.com ctv.veeva.com/study/efficacy-and-safety-study-of-efgartigimod-in-adults-with-post-covid-19-pots

Efficacy and Safety Study of Efgartigimod in Adults With Post ... The study aims to investigate the safety, tolerability, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod compared to ...

4. adisinsight.springer.com adisinsight.springer.com/trials/700365197

Open-Label Extension Study to Evaluate the Long-term Safety ... The OLE study aims to investigate the safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod in participants ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05633407

Efficacy and Safety Study of Efgartigimod in Adults With ... 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 ...

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05918978/

Trial | NCT05918978 The OLE study aims to investigate the safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod in participants with ...