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NCT Number: NCT03936335

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

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.

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Key information

Conditions

Adverse Pregnancy Outcomes Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Regeneron Research Site

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dupilumab

Drug

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.

Other names: REGN668, Dupixent®, SAR23189

Primary outcomes

  1. Prevalence of MCMs

    Time frame: 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

Secondary outcomes

  1. Incidence of spontaneous abortion or miscarriage

    Time frame: Up to 9 months

    Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024

  2. Incidence of stillbirth

    Time frame: Up to 9 months

    Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024

  3. Incidence of SGA

    Time frame: Up to 21 months

    Identified through the presence of corresponding codes on the insurance claims for infant outcomes: 01 April 2017 through December 2024

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
May 3, 2019
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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