Adverse Pregnancy OutcomesNCT03936335
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
An observational study of Adverse Pregnancy Outcomes and Atopic Dermatitis, run by Regeneron Pharmaceuticals at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Adverse Pregnancy Outcomes, Atopic Dermatitis
- What is being tested?
- dupilumab
- How many people
- 12,343 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 13 Apr 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
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))
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Regeneron Research Site
Boston, Massachusetts, 02215
About this study
Official title: Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)
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
- Being tested
- dupilumab
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dupilumabDrug
Also called REGN668, Dupixent®, SAR23189
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.
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab cohort | Exposed to dupilumab during the relevant exposure window:
* First trimester
* Pregnancy Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 21 months
Secondary outcomes (3)
Incidence of spontaneous abortion or miscarriage
Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024
Measured: Up to 9 months
Incidence of stillbirth
Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024
Measured: Up to 9 months
Incidence of SGA
Identified through the presence of corresponding codes on the insurance claims for infant outcomes: 01 April 2017 through December 2024
Measured: Up to 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start30 Sep 2019
- Primary completion13 Apr 2026
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Pregnancy OutcomesStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12,343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936335
- Sponsor's protocol ID
- R668-AD-1760
- Other IDs
- 43838
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2019
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No