NCT03936335

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

Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,930 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

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

• Adverse Pregnancy Outcomes
• Atopic Dermatitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-30
• Primary completion: 2027-01-21
• Completion: 2027-01-21
• First posted: 2019-05-03
• Last updated: 2025-08-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study