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

NCT ID: NCT03936335

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3930 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-30

Study Completion Date

2027-01-21

Brief Summary

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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.

Detailed Description

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Conditions

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Adverse Pregnancy Outcomes Atopic Dermatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Dupilumab cohort

Exposed to dupilumab during the relevant exposure window:

* First trimester
* Pregnancy

dupilumab

Intervention Type 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 systemic therapy or phototherapy cohort

Exposed to systemic medications other than dupilumab or to phototherapy during the relevant exposure window:

* First trimester
* Pregnancy

No interventions assigned to this group

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

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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REGN668 Dupixent® SAR23189

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Regeneron Research Site

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Trials Administrator

Role: CONTACT

844-734-6643

Other Identifiers

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43838

Identifier Type: REGISTRY

Identifier Source: secondary_id

R668-AD-1760

Identifier Type: -

Identifier Source: org_study_id

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