Things to consider

Pregnant women who think they match the inclusion criteria but live in a country where there is no study centre open may be able to take part in the study anyway and are therefore strongly encouraged to reach out to the sites' investigators whose contacts are in the contact section.

You will need to have a genetic confirmation of your XLHED carrier status to be able to participate in the study. If you are unsure about this, please contact your general practitioner or clinical geneticist, who should be able to help you with this requirement.

Please be advised that the procedures and tests you will undergo as part of the study do not in any way replace your standard pregnancy care, which will need to carry on as usual. Study visits come on top of all other routine medical care.

Please note that ER004 treatment is not a gene therapy treatment and will not make any changes to the DNA inside your baby’s cells. Instead, ER004 is designed to correct your baby’s development during the third trimester only. Your son will be able to pass on the faulty XLHED gene to his daughters.

We recommend that you give birth at the clinical centre where the study takes place. This should make it easier for your and your son’s follow-up and will ensure that very important data at birth can be collected. However, it is up to you where you give birth. If you prefer to give birth at your local hospital, please inform the study doctor, as soon as possible. If you plan a homebirth you cannot be included in this study. While planned homebirths are not allowed in the study, babies born out of hospital due to unforeseen circumstances will remain included in the study.

Covid vaccination is not a requirement to take part in the study. However, you will be tested for Covid at each visit for the ER004 injections and also at delivery.

We ask you to consider that this study is a very long-term commitment. Your son will be followed up in the clinical centre until he is 5 years old and there will be 10 visits to the centre from birth onwards. We know this is a really big ask but we do need to make sure the potential benefits of the treatment are long-lasting for the medicine to be considered properly tested. To confirm this, we need to see your son regularly until he is 5.

While you and your son are participating in the study, you will not be allowed to take part in another research study.

Being interviewed and recorded as part of the study might be upsetting or might make you feel uncomfortable. You will be able to pause or stop the interview at any point. Signposting for support will also be given to you.

If you take part in this study, you will not be paid or rewarded in any other material way by the Sponsors or its representatives.

Expenses incurred for participation in the study will be reimbursed, based on local requirements.

During your study participation, you will be offered door-to-door travel arrangement and management services for your study visits.