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

NCT03936335 | Recruiting FDA Drug

• 2 other identifiers: R668-AD-176043838
• Study Type: observational
• Target: 3,930
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Prevalence of MCMs

  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

  Up to 21 months

Secondary Outcomes (3)

• Incidence of spontaneous abortion or miscarriage

  Up to 9 months

• Incidence of stillbirth

  Up to 9 months

• Incidence of SGA

  Up to 21 months

Study Arms (3)

Dupilumab cohort

Exposed to dupilumab during the relevant exposure window: * First trimester * Pregnancy

Drug: dupilumab

Other systemic therapy or phototherapy cohort

Exposed to systemic medications other than dupilumab or to phototherapy during the relevant exposure window: * First trimester * Pregnancy

Unexposed cohort

* Not exposed to systemic medications (including dupilumab) or phototherapy; and * Received topical prescription therapy, or a second diagnosis for AD on a date that differs from the base population qualifying AD diagnosis date during the relevant exposure window: * First trimester * Pregnancy

Interventions

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.

Also known as: REGN668, Dupixent®, SAR23189

Dupilumab cohort

Eligibility Criteria

• Age: 18 Years - 49 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult women with AD who are pregnant between 01 April 2017 and 31 March 2024 (with the start of pregnancy to be defined by the estimated last menstrual period (LMP))

You may qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (1)

Regeneron Research Site

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 3, 2019
• Study Start: September 30, 2019
• Primary Completion (Estimated): January 21, 2027
• Study Completion (Estimated): January 21, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)