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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)
- ClinicalTrials.gov ID
- NCT03936335
- Acronym / sponsor ID
- R668-AD-1760
- Conditions
- Adverse Pregnancy Outcomes, Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,343 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dupilumab cohort | – | Drug: dupilumabExposed to dupilumab during the relevant exposure window: * First trimester * Pregnancy |
| 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 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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))
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dupilumabAlso: REGN668, Dupixent®, SAR23189No 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. | Drug | Dupilumab cohort |
Primary outcome
Prevalence of MCMs
Time frame: 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 December 2024
3 secondary outcomes
Incidence of spontaneous abortion or miscarriage
Time frame: Up to 9 months
Incidence of stillbirth
Time frame: Up to 9 months
Incidence of SGA
Time frame: Up to 21 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Pregnancy Outcomes and Atopic Dermatitis, run by Regeneron Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of MCMs (time frame: Up to 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.