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

NCT04980638 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-30

No results posted yet for this study

Summary

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.

Conditions

  • X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)

Interventions

BIOLOGICAL

ER004

Intra-amniotic route 100 mg/kg of estimated fetal weight per injection. 3 injections, approximately 3 weeks apart starting from gestational week 26

Sponsors & Collaborators

  • Pierre Fabre Medicament

    collaborator INDUSTRY

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • EspeRare Foundation

    lead OTHER

Principal Investigators

  • Holm Schneider, MD · University Erlangen-Nürnberg Erlangen, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-26
Primary Completion
2027-02-28
Completion
2032-12-31
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04980638 on ClinicalTrials.gov