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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: Recruiting Phase 2 study of X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED), sponsored by EspeRare Foundation.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
For treated subject, mean sweat volume is collected on both forearms after local stimulation with pilocarpine (pilocarpine-induced sweating)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-04-26 |
| Est. Completion | 2032-12 |
| Phase | Phase 2 |
What NCT04980638 shows while recruiting
NCT04980638 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
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 lists 8 locations in 7 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04980638's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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