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: Completed Phase 3 study, sponsored by Regeneron Pharmaceuticals.

NCT01949311 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 2,733 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (254% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 2,733 participants
Start Date 2013-10-10
Est. Completion 2022-06-27
Phase Phase 3
Regeneron Pharmaceuticals

280 total trials

What the finished NCT01949311 record still lists

NCT01949311 is an interventional study that assigns participants to a tested intervention. Its 2,733 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (254% higher).

The record links to 0 conditions, and to 1 intervention - of which Dupilumab is the first listed.

NCT01949311 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01949311's enrollment target sits among peer trials

2,733 83rd of 2000 higher than 1,918 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT06085833 · 2,706 participants · NA

    ARTIDIS Nanomechanical Generated Measurements for Early Breast Lesions

  • NCT04073420 · 2,700 participants

    Medtronic Cardiac Surgery PMCF Registry

  • NCT05125939 · 2,700 participants

    Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study

  • NCT05586776 · 2,700 participants · Phase 4

    Decolonization to Reduce After-Surgery Events of Surgical Site Infection

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT01949311, the US trial registry maintained by the National Library of Medicine. NCT01949311 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.