An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)

NCT03936335 · tracked via the Priya Life Science USA tracker

Sponsor

Regeneron Pharmaceuticals

Phase

Observational

Started

2019-09-30

Last updated

2025-08-03

Condition(s) studied

Adverse Pregnancy OutcomesAtopic Dermatitis

Investigational drug(s) / intervention(s)

dupilumab

dupilumab: No study drug will be administered. This study is based on an analysis of automated medical and prescription claims, supplemented by information abstracted from the medical record.

Study summary

The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion/miscarriage, stillbirth) and prevalence of adverse infant outcomes (major congenital malformations \[MCMs\], small for gestational age \[SGA\]) in women with AD who are treated with dupilumab during pregnancy relative to women with AD who are not treated with dupilumab during pregnancy.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

49 Years

Healthy volunteers

Key Inclusion Criteria: * Continuous medical and pharmacy benefit coverage for at minimum 6 months prior to and including the estimated LMP * Diagnosis code indicative of AD in the period from up to 1 year prior to the estimated LMP through the end of the pregnancy Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Primary outcome measure(s)

Prevalence of MCMs — Up to 21 months
Initially identified through the presence of corresponding codes on the insurance claims, confirmed through medical record review for infant outcomes: 01 April 2017 through December 2024

Trial sites (1)

Facility	City	Region	Status
Regeneron Research Site	Boston	Massachusetts	Recruiting

On this site

📄 Dupixent (dupilumab) drug profile →

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Other trials for the same condition

A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis Active, not recruiting

A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis Recruiting

Investigating Participation Patterns of Patients in Atopic Dermatitis Clinical Trials Starting soon

Platform Study to Evaluate the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis Recruiting

Evaluate Efficacy and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03936335 on ClinicalTrials.gov ↗ ← All trials in the USA