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

NCT03936335 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3930

Last updated 2025-08-03

No results posted yet for this 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.

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2027-01-21
Completion
2027-01-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03936335 on ClinicalTrials.gov