Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01949311 · ClinicalTrials.gov registry record · Phase 3
Open-label Study of Dupilumab in Patients With Atopic Dermatitis
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,733
- Enrollment target
NCT01949311 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 2,733 participants.
The verdict
NCT01949311, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,733 participants
- Enrollment target
Study Summary
The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD). The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment. Optional Sub-Study: The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product. The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.
Interventions
- DRUG Dupilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,733 participants |
| Start Date | 2013-10-10 |
| Est. Completion | 2022-06-27 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01949311
The ClinicalTrials.gov registry entry for NCT01949311 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,733 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dupilumab is the first listed.
NCT01949311 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01949311 about?
NCT01949311 is a clinical study titled "Open-label Study of Dupilumab in Patients With Atopic Dermatitis". The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD). The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor effica...
What is the current status of trial NCT01949311?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,733 participants. The study started on 2013-10-10. Estimated completion is 2022-06-27.
What interventions are being tested in trial NCT01949311?
The interventions under investigation include: Dupilumab (DRUG).
Who is sponsoring clinical trial NCT01949311?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.