A phase 2 open-label study to evaluate the safety/efficacy of EDI200

• Research type

  Research Study

• Full title

  A Phase 2 open-label, dose-escalation study to evaluate the safety, pharmacokinetics, immunogenicity and pharmacodynamics/efficacy of EDI200, an EDA-A1 replacement protein, administered to male infants with X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)

• IRAS ID

  124217

• Contact name

  Helen Falconer

• Contact email

  falconerhe@cardiff.ac.uk

• Sponsor organisation

  LUMIS International GmbH

• Eudract number

  2012-003561-17

• Clinicaltrials.gov Identifier

  NCT01775462

• REC name

  Wales REC 3

• REC reference

  13/WA/0382

• Date of REC Opinion

  13 Jan 2014

• REC opinion

  Further Information Favourable Opinion