Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04980638 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED), sponsored by EspeRare Foundation.

Recruiting
Registry status
Phase 2
Development phase
20
Enrollment target
8
Study locations

NCT04980638 is a Phase 2 study of X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) that is actively recruiting participants, run by EspeRare Foundation. The registered enrollment target is 20 participants. The trial reports 8 study locations across 7 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04980638, a Phase 2 study of X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED), is actively recruiting participants, sponsored by EspeRare Foundation.

RECRUITING
Registry status
Phase 2
Development phase
20 participants
Enrollment target
8
Study locations

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.

Interventions

  • BIOLOGICAL ER004

Study Locations (8)

Other

  • IRCCS Ca' Granda Ospedale Policlinico - Milan
  • University Hospital of Wales Cardiff and Vale University Local Health - Cardiff

California

  • Cedars-Sinai Medical Center - Los Angeles

Missouri

  • Washington University - St Louis

Paris

  • Hôpital Necker - Enfants Malades - Paris

Bavaria

  • Universitaetsklinikum Erlangen - Erlangen

Saxony

  • Universitaetsklinikum Leipzig AoeR - Leipzig

Murcia

  • Hospital Universitario Virgen de la Arrixaca - El Palmar

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2022-04-26
Est. Completion 2032-12
Phase Phase 2

Sponsor

EspeRare Foundation

1 total trials

What the Registry Record Tells You About NCT04980638

The ClinicalTrials.gov registry entry for NCT04980638 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EspeRare Foundation, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED) appearing as the primary indexed condition, and to 1 intervention - of which ER004 is the first listed.

NCT04980638 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Other, California, Missouri.

Frequently Asked Questions

What is clinical trial NCT04980638 about?

NCT04980638 is a clinical study titled "Intraamniotic Administrations of ER004 to Male Subjects With X-linked Hypohidrotic Ectodermal Dysplasia". 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.

What is the current status of trial NCT04980638?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2022-04-26. Estimated completion is 2032-12.

What conditions does trial NCT04980638 study?

This clinical trial studies the following conditions: X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED).

What interventions are being tested in trial NCT04980638?

The interventions under investigation include: ER004 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04980638?

This trial is sponsored by EspeRare Foundation, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04980638 being conducted?

This trial has 8 study locations across California, Missouri, Paris, Bavaria, Saxony. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.