Efgartigimod for Post-COVID-19 POTS

(POTS Trial)

No longer recruiting at 8 trial locations

Overseen By Sabine Coppieters, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: argenx

Disqualifiers: Pregnancy, Breastfeeding, Significant conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called efgartigimod (an immunotherapy) for individuals with post-COVID-19 POTS, a condition causing dizziness or faintness upon standing. The goal is to determine if efgartigimod is safe and effective for treating these symptoms. Participants will receive the treatment through an IV over 48 weeks. Ideal candidates have already participated in a specific earlier study and are prepared to continue without a break. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

Research has shown that efgartigimod is generally safe for people. In earlier studies, participants tolerated it well, experiencing only mild to moderate side effects. These side effects often include headaches and nausea, common with many medications. Importantly, no reports have indicated serious problems directly caused by efgartigimod.

The FDA has approved efgartigimod for other conditions, indicating a well-understood safety profile. Many people have used it without major issues. While this trial focuses on post-COVID-19 POTS, the existing safety data for efgartigimod is reassuring. However, discussing any concerns with the trial staff or a doctor is always advisable. ^{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) that often include lifestyle changes, beta-blockers, or fludrocortisone, efgartigimod offers a fresh approach. This drug is unique because it works by modulating the immune system, specifically targeting and reducing autoantibodies that may contribute to POTS symptoms, which is different from the current symptom-focused therapies. Researchers are excited about efgartigimod because it has the potential to address the underlying causes of POTS, offering hope for more effective and long-lasting relief for patients.

What evidence suggests that efgartigimod might be an effective treatment for post-COVID-19 POTS?

Studies have shown that efgartigimod lowers levels of IgG, an antibody type involved in autoimmune responses. This suggests it might help with conditions like post-COVID-19 POTS (Postural Orthostatic Tachycardia Syndrome), where the immune system could play a role. However, in a previous study, patients with post-COVID-19 POTS treated with efgartigimod did not experience significant improvement. While efgartigimod is effective for other conditions, it has not been proven to work specifically for post-COVID-19 POTS. Participants in this trial will receive efgartigimod to further evaluate its potential effectiveness for post-COVID-19 POTS. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults who have had COVID-19 and now suffer from Postural Orthostatic Tachycardia Syndrome (POTS), causing rapid heartbeat when standing. Participants must have finished a previous efgartigimod study, not be planning pregnancy or breastfeeding, agree to use contraception, and sign consent forms.

Inclusion Criteria

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.

I am a woman who can have children and have a negative pregnancy test.

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive efgartigimod IV 10 mg/kg infusions

48 weeks

Regular visits for infusions

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

Open-label extension

Long-term evaluation of safety and efficacy of efgartigimod in PC-POTS patients

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Efgartigimod

Trial Overview The trial tests the safety and effectiveness of a drug called efgartigimod in treating POTS symptoms following COVID-19. It will also look at how the body processes the drug and its impact on the immune system over time.

How Is the Trial Designed?

Group I: Efgartigimod Experimental Treatment 1 Intervention

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

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]

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05918978

Open Label Extension of Efgartigimod in Adults with Post- ... The OLE study aims to investigate the safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod in participants with ...

7. ctv.veeva.com ctv.veeva.com/study/open-label-extension-of-efgartigimod-in-adults-with-post-covid-19-pots

Open Label Extension of Efgartigimod in Adults with Post ... The OLE study aims to investigate the safety, efficacy, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of efgartigimod in ...