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NCT03346434 · ClinicalTrials.gov registry record · Phase 2

Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL)

A Phase 2 study of Dermatitis, Atopic, sponsored by Regeneron Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
202
Enrollment target
20
Study locations

NCT03346434 is a Phase 2 study of Dermatitis, Atopic that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 202 participants, below the 390-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT03346434, a Phase 2 study of Dermatitis, Atopic, has completed, sponsored by Regeneron Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
202 participants
Enrollment target
20
Study locations

Study Summary

This study is a 2-part (parts A and B) phase 2/3 study to evaluate the safety, pharmacokinetics (PK) and efficacy of dupilumab in participants 6 months to less than 6 years of age with moderate-to-severe atopic dermatitis (AD).

Conditions Studied

Interventions

  • DRUG Matching placebo
  • DRUG Dupilumab

Study Locations (20)

California

  • Regeneron Investigational Site - Long Beach
  • Regeneron Investigational site - Los Angeles
  • Regeneron Investigational Site - Palo Alto
  • Regeneron Investigational Site - Rolling Hills Estates
  • Regeneron Investigational Site - San Diego

Georgia

  • Regeneron Investigational Site - Columbus
  • Regeneron Investigational Site - Macon
  • Regeneron Investigational Site - Sandy Springs

Florida

  • Regeneron Investigational Site - Coral Gables
  • Regeneron Investigational Site - Tampa

Michigan

  • Regeneron Investigational Site - Ann Arbor
  • Regeneron Investigational Site - Ypsilanti

Alabama

  • Regeneron Investigational Site - Birmingham

Arizona

  • Regeneron Investigational Site - Gilbert

District of Columbia

  • Regeneron Investigational Site - Washington D.C.

Illinois

  • Regeneron Investigational Site - Chicago

Trial Details

FieldValue
Enrollment Target 202 participants
Start Date 2017-11-30
Est. Completion 2021-07-08
Phase Phase 2

Sponsor

Regeneron Pharmaceuticals

280 total trials

What the Registry Record Tells You About NCT03346434

The ClinicalTrials.gov registry entry for NCT03346434 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 390-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (48% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Dermatitis, Atopic appearing as the primary indexed condition, and to 2 interventions - of which Matching placebo is the first listed.

NCT03346434 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Georgia, Florida.

Frequently Asked Questions

What is clinical trial NCT03346434 about?

NCT03346434 is a clinical study titled "Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL)". This study is a 2-part (parts A and B) phase 2/3 study to evaluate the safety, pharmacokinetics (PK) and efficacy of dupilumab in participants 6 months to less than 6 years of age with moderate-to-severe atopic dermatitis (AD).

What is the current status of trial NCT03346434?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 202 participants. The study started on 2017-11-30. Estimated completion is 2021-07-08.

What conditions does trial NCT03346434 study?

This clinical trial studies the following conditions: Dermatitis, Atopic.

What interventions are being tested in trial NCT03346434?

The interventions under investigation include: Matching placebo (DRUG), Dupilumab (DRUG).

Who is sponsoring clinical trial NCT03346434?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03346434 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.