Efgartigimod for Post-COVID POTS

(POTS Trial)

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

53 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called efgartigimod, which lowers specific antibodies, in people who have POTS after recovering from COVID-19. The goal is to see if it can help reduce their symptoms.

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.

What data supports the effectiveness of the drug Efgartigimod for treating post-COVID POTS?

There is no direct evidence from the provided research articles about the effectiveness of Efgartigimod for treating post-COVID POTS. However, since POTS may have an immune-mediated component, and Efgartigimod is known to modulate the immune system, it could potentially be beneficial, similar to how intravenous immunoglobulin (IVIG) has been used in immune-mediated POTS cases. ^{1 2 3 4 5}

How is the drug Efgartigimod unique for treating Post-COVID POTS?

Efgartigimod is unique because it is designed to modulate the immune system by targeting antibodies, which may help in conditions like Post-COVID POTS where the immune system is thought to play a role. Unlike other treatments that might focus on symptoms, Efgartigimod's approach is to address the underlying immune response. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Postural orthostatic tachycardia syndrome as a sequela of COVID-19. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical and Laboratory Improvement in Hyperadrenergic Postural Orthostatic Tachycardia Syndrome (POTS) after COVID-19 Infection. [2021]

3. Italy pubmed.ncbi.nlm.nih.gov

Persistent Antiphospholipid Antibodies, Mast Cell Activation Syndrome, Postural Orthostatic Tachycardia Syndrome and Post-COVID Syndrome: 1 Year On. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

COVID-19 Induced Postural Orthostatic Tachycardia Syndrome (POTS): A Review. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Immunomodulatory treatment in postural tachycardia syndrome: A case series. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Efbemalenograstim Alfa: First Approval. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Pegfilgrastim; a neutrophil mediated granulocyte colony stimulating factor-expanding uses in cancer chemotherapy. [2022]

8. China 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta®): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Eflapegrastim, a Long-Acting Granulocyte-Colony Stimulating Factor for the Management of Chemotherapy-Induced Neutropenia: Results of a Phase III Trial. [2021]