Myasthenia GravisNCT06299748
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
An observational study of Myasthenia Gravis and CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, run by argenx at 4 sites in 4 countries.
Trial summary
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 conception or any time during pregnancy. Women exposed to efgartigimod or efgartigimod PH20 SC only during breastfeeding will also be eligible to enroll. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Myasthenia Gravis, CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
- What is being tested?
- Efgartigimod
- Type of treatment
- Injection or infusion
- How many people
- 279 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 30 Nov 2023to Dec 2033
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women or women no longer pregnant at the time of study enrollment but exposed to efgartigimod any time within 25 days prior to conception or any time during the pregnancy.
Who may be able to join
- Women with exposure to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy, or women with exposure to efgartigimod or efgartigimod PH20 SC during breastfeeding. The timeframe of 25 days prior to conception is calculated based on five times the efgartigimod half-life, which is 3 to 5 days.
- Written/verbal informed consent or eConsent (depending on country regulations) (for adolescents under the age of majority, written/verbal informed assent or eConsent by the pregnant minor (where applicable) and written/verbal informed consent or eConsent by the parent/legal guardian).
Who cannot join
- None
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
United States1 site, 1 recruiting
- Recruiting
United BioSource LLC
Morgantown, West Virginia, 26508
Sabine Coppieters, MD, 857-350-4834, clinicaltrials@argenx.com
Germany1 site, 1 recruiting
- Recruiting
Klinikum der Ruhr-Universität Bochum St. Josef Hospital Neurologische Interdisziplinäre Infusionsambulanz + MS Studienambulanz (Haus E Ebene1)
Bochum, 44791
Sabine Coppieters, MD, 857-350-4834, clinicaltrials@argenx.com
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Sabine Coppieters, MD, 857-350-4834, clinicaltrials@argenx.com
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Sabine Coppieters, MD, 857-350-4834, clinicaltrials@argenx.com
About this study
Official title: A Worldwide Pregnancy Safety Study To Assess Maternal, Fetal, And Infant Outcomes Following Exposure To Efgartigimod During Pregnancy And/Or Breastfeeding
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 conception or any time during pregnancy. Women exposed to efgartigimod or efgartigimod PH20 SC only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the efgartigimod or efgartigimod PH20 SC exposed pregnancies were reported.
- Being tested
- Efgartigimod
- Medical subject headings
- Myasthenia Gravis, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfgartigimodBiological
Efgartigimod IV or SC
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Pregnancy | 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 Receives: Biological: Efgartigimod | |
| Prospective Pregnancy | woman is pregnant or breastfeeding at time of study enrollment. Receives: Biological: Efgartigimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy outcomes
Pregnancy outcomes: Spontaneous abortion; Elective or therapeutic abortion; Fetal death/stillbirth ; Molar or ectopic pregnancy; Live birth (Preterm delivery; Fullterm delivery)
Measured: up to 10 years
Secondary outcomes (5)
Congenital malformations
Congenital malformations (CDC 2020b) identified in the developing fetus, neonate, or infant: Major congenital malformations (MCMs); Minor congenital malformations
Measured: up to 10 years
The number of observed other events of interest in the developing neonate and infant (such as hospitalizations for serious illness)
Other events of interest identified in the developing neonate and infant (Hospitalizations for serious illness; Potential adverse reactions to medications; Growth and development milestones as described by the Centers for Disease Control and Prevention or other accepted standard assessments; Infant developmental deficiency; Postnatal growth deficiency or failure to thrive (FTT); Neonatal and infant mortality; Infections; Transient neonatal myasthenia; Vaccination and vaccine reactions
Measured: up to 10 years
Maternal complications of pregnancy
Maternal complications of pregnancy, including but not limited to: Premature rupture of membranes (PROM); Preterm PROM (PPROM); Pre-eclampsia; Gestational hypertension; Eclampsia; Proteinuria; Gestational diabetes; Intrauterine growth restriction (IUGR); Polyhdramnios
Measured: up to 10 years
Maternal infections
Measured: up to 10 years
The number of observed fetal growth deficiency
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start30 Nov 2023
- Primary completionJan 2033 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 279 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299748
- Sponsor's protocol ID
- ARGX-113-PAC-2206
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided