Efgartigimod for Post-COVID-19 POTS

(POTS Trial)

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

33 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing efgartigimod, a medication given through an IV drip, in adults with post-COVID-19 postural orthostatic tachycardia syndrome (PC-POTS). The goal is to see if it is safe and effective. Efgartigimod works by calming down parts of the immune system that might be causing issues in these patients.

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.

What makes the drug Efgartigimod unique for treating Post-COVID-19 POTS?

Efgartigimod is unique because it works by reducing the levels of antibodies in the blood, which is different from other treatments for Post-COVID-19 POTS that may not target the immune system in this way. This mechanism is similar to how it is used in other conditions like myasthenia gravis, where it helps by modulating the immune response. ^{1 2 3 4 5}

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. 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]

2. England pubmed.ncbi.nlm.nih.gov

A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a Phase III, Randomized, Double-Blind Trial. [2022]

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

Pharmacokinetic and Pharmacodynamic Bioequivalence of Pegfilgrastim-cbqv Delivered via a Prefilled Autoinjector and Prefilled Syringe in Healthy Male Participants. [2023]

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

Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta® in healthy subjects: A randomized, double-blind trial. [2021]

5. 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]