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

StatusCompleted
PhaseNot specified
Started2019-09-30
View on ClinicalTrials.gov ↗

Amendment history

2026-09-29
Trial completed
Final enrollment: 12343 participants (planned 3930)
Primary completion confirmed: April 2026 (last estimated January 2027)
2025-07-30
Study Identification, Study Status, Study Description, Outcome Measures v6
Primary completion date2027-07-21→2027-01-21
Completion date2027-07-21→2027-01-21
Secondary endpoints3 entries, revised
Incidence of small for gestational ageSGA
Primary endpoints1 entry, revised
IncidencePrevalence of major congenital malformationsMCMs
2024-10-16
2 amendments v4-v5
2 re-verifications since 2023-05-11, no change to tracked fields
2022-02-03
Study Identification, Study Status v3
Study title-20 characters
DupilumabAn and Pregnancy Outcomes: AObservational Retrospective Cohort Study UsingBeing AdministrativeConducted Healthcarein DatabasesWomen With Atopic Dermatitis (Dupi PODSAD)
2020-10-28
Study Status v2
Re-verified, no change to tracked fields
2019-11-06
Not Yet Recruiting→Recruiting Study Status, Oversight, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations, IPDSharing v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-07-16→2027-07-21
Completion date2026-07-16→2027-07-21
Start dateestimated 2019-05-20→confirmed 2019-09-30
Enrollment target2833→3930
Study sites0→1
Secondary endpoints+111 characters
Incidence of spontaneous abortion or miscarriage Incidence of stillbirth Incidence of small for gestational age
Primary endpoints4 to 1 entries
MajorIncidence of major congenital malformations Small for gestational age Spontaneous abortion or miscarriage Stillbirth
2019-04-30
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
Atopic Dermatitis
489 trials monitored
See 14 trials at risk
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.
Trial Details
NCT Number NCT03936335
Lead Sponsor Regeneron Pharmaceuticals
Collaborators: Sanofi
Conditions Adverse Pregnancy Outcomes, Atopic Dermatitis
Enrollment 12,343 participants
Start Date 2019-09-30
Primary Completion 2026-04-13 (estimated)
Study Completion 2026-04-13 (estimated)
Updated on ClinicalTrials.gov 2026-09-28