Efgartigimod Safety for Myasthenia Gravis During Pregnancy

Recruiting at 3 trial locations

Overseen By Sabine s Coppieters, MD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: argenx

Must be taking: Efgartigimod

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

Compensation: Varies

Number of Visits: Unknown

279 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety of efgartigimod, a medication, for pregnant or breastfeeding women and their babies. Researchers seek to determine if efgartigimod affects the health of mothers, fetuses, and infants. The study includes two groups: women who are pregnant or breastfeeding and have been exposed to the drug, and women who were exposed during pregnancy but are no longer pregnant. Women who have used efgartigimod within 25 days before becoming pregnant or during pregnancy or breastfeeding may be suitable candidates. As a Phase 4 trial, this study involves an FDA-approved treatment, providing insights into its benefits for more 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 focuses on women who have been exposed to efgartigimod during pregnancy or breastfeeding.

What is the safety track record for efgartigimod and efgartigimod PH20 SC?

Research shows that efgartigimod, available in both intravenous (IV) and subcutaneous forms, has been tested in healthy individuals before. These studies found that the treatment is generally well-tolerated, with most participants not experiencing serious side effects. Some reported mild issues, such as headaches or reactions at the injection site.

While this trial examines the safety of efgartigimod during pregnancy, it is important to note that the FDA has already approved it for other uses, indicating its safety for those purposes.

This trial specifically targets pregnant or breastfeeding women, and researchers are still gathering safety information for this group. The study aims to understand any risks to mothers, unborn babies, and infants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about efgartigimod because it offers a novel approach to managing autoimmune conditions during pregnancy and breastfeeding. Unlike traditional treatments that may pose risks to the developing fetus or infant, efgartigimod is designed to selectively reduce harmful antibodies by targeting the neonatal Fc receptor (FcRn). This mechanism allows for more precise modulation of the immune system without broadly suppressing it, potentially offering a safer option for expectant and new mothers. Additionally, its ability to be administered subcutaneously adds convenience, making it easier for patients to manage their treatment.

What evidence suggests that efgartigimod or efgartigimod PH20 SC is safe for pregnant or breastfeeding women?

This trial focuses on the safety of efgartigimod during pregnancy and breastfeeding. Participants will join either the "Prospective Pregnancy" arm, where the woman is pregnant or breastfeeding at enrollment, or the "Retrospective Pregnancy" arm, where the woman is no longer pregnant but was exposed to efgartigimod or efgartigimod PH20 SC within 25 days before conception or during pregnancy. Studies have shown that efgartigimod effectively treats conditions like myasthenia gravis, which causes muscle weakness, by reducing harmful antibodies that attack the body. Research indicates that this treatment improves muscle strength and patient outcomes. Although the trial does not test its efficacy during pregnancy, its success in treating autoimmune conditions suggests potential benefits. Early data shows promising results for similar conditions, warranting further study. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

I have not been exposed to efgartigimod before conception or during pregnancy/breastfeeding.

I have given my written consent, or if I'm a minor, my guardian has consented.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exposure Monitoring

Monitoring of pregnant women exposed to efgartigimod or efgartigimod PH20 SC during pregnancy or breastfeeding

up to 10 years

Follow-up

Participants are monitored for maternal, fetal, and infant outcomes, including congenital malformations and other health events

up to 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Efgartigimod

How Is the Trial Designed?

Group I: Retrospective Pregnancy Experimental Treatment 1 Intervention

woman is no longer pregnant at time of study enrollment but was exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy

Group II: Prospective Pregnancy Experimental Treatment 1 Intervention

woman is pregnant or breastfeeding at time of study enrollment.

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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06299748

NCT06299748 | A Worldwide Pregnancy Safety Study to ...

A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/​or Breastfeeding.

2.

vyvgartpregnancy.com

vyvgartpregnancy.com/

The Argenx VYVGART Pregnancy Observational Study

The purpose of this pregnancy study is to collect valuable information on pregnant women exposed to efgartigimod any time within 25 days prior to conception.

3.

catalogues.ema.europa.eu

catalogues.ema.europa.eu/system/files/2024-02/ARGX-113-PAC-2206-EU%20Protocol-V2.0_fully%20signed-including%20annex4_Redacted.pdf

PASS Protocol Drug Substance Efgartigimod alfa Study Code ...

This pregnancy safety study will assess maternal, foetal, and infant outcomes following exposure to efgartigimod during pregnancy and/or ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06299748?cond=Chronic%20inflammatory%20demyelinating%20polyradiculoneuropathy%20OR%20%22chronic%20inflammatory%20demyelinating%20polyneuropathy%22%20OR%20%22%20chronic%20relapsing%20polyneuropathy%22%20OR%20%22%20CIDP%22&aggFilters=status:not%20rec&viewType=Table&rank=3

A Worldwide Pregnancy Safety Study to Assess Maternal, ...

A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/​or Breastfeeding.

5.

argenx.com

argenx.com/news/2025/press-release-3166778

argenx to Highlight Key Data and Breadth of Immunology ...

Real-world evidence and long-term data reinforce VYVGART's sustained impact on patient outcomes; More than 40 abstracts across MG, CIDP, MMN ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11652471/

Pharmacokinetics, Pharmacodynamics, and Safety of ...

We present the pharmacokinetic, pharmacodynamic, and safety of IV and SC PH20 efgartigimod in healthy Chinese participants.

7.

ctv.veeva.com

ctv.veeva.com/study/a-worldwide-pregnancy-safety-study-to-assess-maternal-fetal-and-infant-outcomes-following-exposure

A Worldwide Pregnancy Safety Study to Assess Maternal ...

This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to ...

8.

argenx.com

argenx.com/news/2024/argenx-highlights-data-showing-patient-impact-across-multiple-im

argenx Highlights Data Showing Patient Impact Across ...

IMPORTANT SAFETY INFORMATION ... Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART.

9.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2024/761304Orig1s000OtherR.pdf

center for drug evaluation and research - accessdata.fda.gov

Safety during pregnancy due to drug exposure is a concern for women who ... Subcutaneous Injections of Efgartigimod PH20 SC With Multiple.