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NCT01775462 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study to Evaluate Safety, Pharmacokinetics, Immunogenicity and Pharmacodynamics/Efficacy of EDI200 in Male Infants With X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)
A Phase 2 study, sponsored by Edimer Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT01775462: Completed Phase 2 study, sponsored by Edimer Pharmaceuticals.
NCT01775462 is a Phase 2 study that has completed, run by Edimer Pharmaceuticals. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01775462, a Phase 2 study, has completed, sponsored by Edimer Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
This Phase 2 first-in-neonate EDI200 study will enroll treatment-naïve, XLHED-affected male newborns in the first two weeks of life. All subjects will meet entry criteria including documentation of an Ectodysplasin (EDA) mutation associated with XLHED. Following Baseline evaluations, EDI200 dosing will be initiated between day-of-life 2 and 14, with each study subject receiving 2 doses/week for a total of 5 doses. The study will enroll subjects in two cohorts with subjects in cohort 1 dosed at 3 mg/kg/dose, associated with partial efficacy, and cohort 2 dosed at 10 mg/kg/dose where enhanced efficacy was demonstrated in the most relevant preclinical model. Given the challenge of identifying families where the subject is yet to be born, it is expected that cohort size and time for recruitment will be variable.
Interventions
- DRUG EDI200
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
What the finished NCT01775462 record still lists
NCT01775462 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which EDI200 is the first listed.
NCT01775462 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01775462 about?
NCT01775462 is a clinical study titled "Phase 2 Study to Evaluate Safety, Pharmacokinetics, Immunogenicity and Pharmacodynamics/Efficacy of EDI200 in Male Infants With X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)". This Phase 2 first-in-neonate EDI200 study will enroll treatment-naïve, XLHED-affected male newborns in the first two weeks of life. All subjects will meet entry criteria including documentation of an Ectodysplasin (EDA) mutation associated with XLHED. Following Baseline evaluations, EDI200 dosing w...
What is the current status of trial NCT01775462?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2013-04. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01775462?
The interventions under investigation include: EDI200 (DRUG).
Who is sponsoring clinical trial NCT01775462?
This trial is sponsored by Edimer Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01775462's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 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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