Previously, six XLHED-affected boys received the investigational medicine before birth and the results indicated the potential to prevent or at least significantly reduce the severity of some XLHED symptoms. These were reported in scientific journals in 2018 and 2023.
We now want to confirm these findings in the Edelife study, with two aims:
If a pregnant woman is eligible a study doctor will infuse the investigational medicine into theamniotic fluid around the baby at three time points between pregnancy weeks 26 and 32. During this stage of pregnancy, babies regularly swallow this fluid, and will therefore swallow the investigational medicine at the same time.
Safety of the participant is always our first concern in a research study, and you and your child’s safety will be closely monitored throughout your participation in the Edelife study. If you would like more information on the potential risks and benefits associated with the investigational medicine, please ask a study doctor.
Participating in Edelife will require study-specific visits to a clinical center. Pregnant women must be at least 18 years of age and enrolled before week 23 of their pregnancy.
If you are interested in taking part in the study or you have any questions about it, please do not hesitate to make contact with a Study Doctor to discuss further.