Intraamniotic Administrations of ER004 to Male Subjects With X-linked Hypohidrotic Ectodermal Dysplasia

Recruiting Phase 2 Interventional Study
X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
EspeRare Foundation · Other
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About This Trial

This is an open-label, prospective, genotype-match controlled for primary estimand, non randomized, multicenter, international Phase 2 clinical trial designed to investigate the efficacy and safety of ER004 administered intraamniotically as a treatment for unborn XLHED male subjects.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: For mother: adult mother with confirmed pregnancy no later than week 23+6 and genetically confirmed as carrier of an EDA mutation * For fetal subject : male fetal subject with confirmed diagnosis of XLHED * For untreated relative: untreated male relative subject aged between 6 …
Contacts

Agnes Jaulent

+41 22 794 4004

Info.er004@esperare.org

CONTACT

Marlène Guiraud

+33 5 34 50 60 00

contact.edelife@pierre-fabre.com

CONTACT