A prenatal study for XLHED affected boys

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A prospective, open-label, genotype-match controlled, multicenter clinical trial to investigate the efficacy and safety of intra-amniotic ER004 as a prenatal treatment for male subjects with X-linked hypohidrotic ectodermal dysplasia (XLHED)

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Status
Status :
Recruiting
Phase
Phase II
Min. Age
-
Max. Age
0
Year old
Gender
Male

Brief summary

This is a prenatal trial for X-linked Hypohidrotic Ectodermal Dysplasia (XLHED) affected boys. The purpose of the trial is to evaluate how prenatal treatment of male fetuses with ER004 works and how it is tolerated. ER004 is an experimental medicine for XLHED not yet approved for use in humans, except in clinical studies.
ER004 is made in a laboratory to replace an important protein called EDA1 (Ectodysplasin-A1), missing in people affected by XLHED. Absence of this protein during the baby’s development in the womb leads to some important structures not forming properly (sweat glands, hair, teeth etc).

Therapeutic area :
Dermatology
Disease :
X-linked hypohidrotic ectodermal dysplasia (XLHED)
Study medication :
ER004
Phase : Phase II
Start Date :
26 April 2022
End Date / Planned study Completion Date :
January 2029
Study ID : ER004-CLIN01/F60082AI201
EudraCT/CTIS number : 2021-002532-23
CT.gov Number : NCT04980638
Co-sponsor(s) :

EspeRare Foundation

Countries :
France
Germany
Italy
Spain
United Kingdom
United States

Find out where the clinical trial is conducted

1

Washington University

660 South Euclid Ave
Washington, MO 63110
United States

Dr. med Dorothy Katherine Grange
Email: grangedk@wustl.edu
Phone: +1 314 454 6093
 

2

University of California

Department of Ob, Gyn & RS Box 0132 490 Illinois Street Floor 10, Room 102L
San francisco, CA CA 94143
United States

3

University Hospital of Wales Cardiff and Vale

Board Heath Park Way
Cardiff
CF14 4WX
United Kingdom

Prof. Dr. med Angus Clarke
Email: clarkeaj@cardiff.ac.uk
Phone: +44 2920 742577 (email preferred)
 

4

Hospital Clinico Universitario Virgen de la Arixacca

3ª planta, Pasillo B Calle Campo nº 12
30120 El palmar
Spain

Dra. med Encarnación Guillén Navarro
Email: guillen.encarna@gmail.com
Phone: +34 968 92 94 29
 

5

Fondazione I.R.C.C.S. Ospedale Maggiore Policlinico

Instituto di Scienze Dermatologiche dell' Università di Mila Via Pace 9
20122 Milano
Italy

Prof. Dr. med Riccardo Cavalli
Email: riccardo.cavalli@policlinico.mi.it
Phone: +39 0255035355
 

6

Universitaetsklini kum Erlangen

Loschgestrasse 15
91054 Erlangen
Germany

Professor Holm Schneider
www.zeder.uk-erlangen.de
Email: holm.schneider@uk-erlangen.de
Phone: +49 9131 8533775

7

Universitaetsklini kum Leipzig

Departement fûr Frauen und Kindermedizin Liebigstrasse 20a
04103 Leipzig
Germany

Prof. Dr. med Holger Stepan
Email: holger.stepan@medizin.uni-leipzig.de
Phone: +49 3419723595

8

AP-HP Paris

Service de Dermatologie, Centre de référence MAGEC 149 rue des sèvres
75015 Paris
France

Prof. Dr. med Christine Bodemer
Email: christine.bodemer@aphp.fr
Phone: +33 1 44 49 43 37

Last update at : 19 December 2022

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