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NCT01979016 · ClinicalTrials.gov registry record · Phase 2

Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)

A Phase 2 study, sponsored by Regeneron Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
54
Enrollment target

NCT01979016: Completed Phase 2 study, sponsored by Regeneron Pharmaceuticals.

NCT01979016 is a Phase 2 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 54 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01979016, a Phase 2 study, has completed, sponsored by Regeneron Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
54 participants
Enrollment target

Study Summary

The primary objective of the study was to assess the efficacy of Dupilumab, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).

Primary Outcome

The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Values after first rescue medication use were set to missing and missing values imputed by last observation carried forward

Interventions

  • DRUG Placebo
  • DRUG Dupilumab
  • OTHER Background treatment

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2013-12-31
Est. Completion 2015-01-31
Phase Phase 2
Regeneron Pharmaceuticals

280 total trials

What the finished NCT01979016 record still lists

NCT01979016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01979016 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01979016 about?

NCT01979016 is a clinical study titled "Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)". The primary objective of the study was to assess the efficacy of Dupilumab, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).

What is the current status of trial NCT01979016?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2013-12-31. Estimated completion is 2015-01-31.

What interventions are being tested in trial NCT01979016?

The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG), Background treatment (OTHER).

Who is sponsoring clinical trial NCT01979016?

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 NCT01979016's enrollment target sits among peer trials

54 1160th of 2000 higher than 830 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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Source: ClinicalTrials.gov NCT01979016, the US trial registry maintained by the National Library of Medicine. NCT01979016 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.