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

Recruiting

• Conditions: Adverse Pregnancy Outcomes; Atopic Dermatitis
• Interventions: Drug: dupilumab

• Registration Number: NCT03936335
• Lead Sponsor: Regeneron Pharmaceuticals

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-03
• Study Start: 2019-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2027-07-21
• Study Completion: 2027-07-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 3930

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dupilumab cohort	dupilumab	Exposed to dupilumab during the relevant exposure window: * First trimester * Pregnancy

Primary Outcome Measures

Name	Time	Method
Incidence of major congenital malformations	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 31 July 2023

Secondary Outcome Measures

Name	Time	Method
Incidence of spontaneous abortion or miscarriage	Up to 9 months	Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024
Incidence of stillbirth	Up to 9 months	Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024
Incidence of small for gestational age	Up to 21 months	Identified through the presence of corresponding codes on the insurance claims for infant outcomes: 01 April 2017 through 31 July 2023

Trial Locations

Locations (1)

Regeneron Research Site; 🇺🇸 Boston, Massachusetts, United States