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COMPLETED Phase 2

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

NCT03346434 · View on ClinicalTrials.gov ↗

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

290 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03346434

The ClinicalTrials.gov registry entry for NCT03346434 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03346434 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Georgia, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03346434?

The interventions under investigation include: Matching placebo (DRUG), Dupilumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03346434?

This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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