Atopic Dermatitis (AD)NCT04173442
Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy
An observational study of Atopic Dermatitis (AD) and Asthma, run by Regeneron Pharmaceuticals at 1 site in United States.
Trial summary
The objective is to evaluate the potential effect of exposure to dupilumab in pregnancy compared to the primary comparison group of disease-matched pregnant women who are not exposed to dupilumab, and the secondary comparison group of healthy pregnant women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis (AD), Asthma
- What is being tested?
- dupilumab
- How many people
- 581 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2018to 4 Nov 2025
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes pregnant women who reside in the US or Canada with dupilumab- exposure for the approved indication, and 2 comparison groups without dupilumab exposure during pregnancy (1 disease-matched unexposed comparison group, and 1 healthy unexposed comparison group).
Who may be able to join
- Cohort 1: Dupilumab-Exposed Cohort
- Pregnant women
- Exposure to dupilumab for the treatment of the approved indications of atopic dermatitis (AD) or asthma, for any number of days, at any dose, and at any time from the first day of the LMP up to and including the end of pregnancy.
- Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)
- Pregnant women
- Diagnosed with a dupilumab-approved indications of moderate-to-severe AD without asthma or moderate-to-severe asthma; frequency matched to the exposed group by disease indication, with the indication and severity validated by medical records when possible.
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- No exposure to dupilumab any time in the current pregnancy or within 10 weeks of the first day of the LMP and may or may not have taken another medication for their disease in the current pregnancy.
- Cohort 3: Healthy Comparison Cohort (Comparison Group 2):
- Pregnant women
Who cannot join
- Cohort 1: Dupilumab-Exposed Cohort
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- Women who have used dupilumab for an indication other than asthma or AD
- Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1):
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- Exposure to dupilumab within 10 weeks of LMP or anytime during the current pregnancy
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- Cohort 3: Non-Diseased Comparison Cohort (Comparison Group 2):
- Exposure to dupilumab within 10 weeks prior to the first day of the LMP
- Women who have a diagnosis of any dupilumab approved indication
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Regeneron Research Site
La Jolla, California, 92093-0934
About this study
Official title: Post-Authorization Safety Study to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy in North America
The objective is to evaluate the potential effect of exposure to dupilumab in pregnancy compared to the primary comparison group of disease-matched pregnant women who are not exposed to dupilumab, and the secondary comparison group of healthy pregnant women.
The primary outcome of the study is major structural defects, and the secondary outcomes of the study are spontaneous abortion/miscarriage, stillbirth, elective termination/abortion, premature delivery, small for gestational age, pattern of 3 or more minor structural defects, postnatal growth of live born children to 1 year of age, postnatal serious or opportunistic infections in live born children to 1 year of age, and hospitalizations in live children up to 1 year of age.
- Conditions
- Atopic Dermatitis (AD), Asthma
- Being tested
- dupilumab
- Medical subject headings
- Dermatitis, Atopic, Asthma
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
Dupilumab cohort
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Dupilumab-Exposed Cohort | Pregnant women with approved indications exposed to dupilumab during pregnancy Receives: Drug: dupilumab | |
| Cohort 2: Disease-Matched Comparison Cohort | Pregnant women with approved indications not exposed to dupilumab during pregnancy | |
| Cohort 3: Healthy Comparison Cohort | Pregnant women who are not diagnosed with any dupilumab-approved indications, and not exposed to dupilumab during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major structural defects
Defined and classified using the Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects
Measured: Up to 1 Year of Age
Secondary outcomes (9)
Incidence of spontaneous abortion or miscarriage
Defined as non-deliberate fetal death
Measured: Up to 20 weeks post-LMP (Last Menstrual period)
Incidence of stillbirth
Defined as non-deliberate fetal death
Measured: At or after 20 weeks post-LMP
Incidence of elective termination/abortion
Defined as deliberate discontinuation of pregnancy through medication or surgical procedures
Measured: Up to 9 months
Incidence of premature delivery
Defined as live birth prior to 37.0 weeks gestation as counted from LMP (or ultrasound-adjusted date)
Measured: Prior to 37 weeks of gestation
Incidence of small for gestational age
Defined as birth size (weight, length or head circumference) less than or equal to the 10th centile for sex and gestational age using standard pediatric CDC growth curves for full term or preterm infants
Measured: At Birth
Incidence of a pattern of 3 or more minor structural defects
Identified by a study examiner: Defined as 1 of the defects representing a structural anomaly which has neither cosmetic nor functional significance to the child
Measured: Between Birth and Up to 1 Year of Age
Postnatal growth deficiency
Defined as postnatal size (weight, length or head circumference) less than or equal to the 10th centile for sex and age using standard pediatric growth curves, and adjusted for postnatal age for premature infants if the postnatal measurement is obtained at less than 1 year of age.
Measured: Up to 1 Year of Age
Incidence of postnatal serious or opportunistic infections in live born children
Defined as any infection resulting in hospitalization
Measured: Up to 1 Year of Age
Incidence of hospitalizations in live born children
Defined as any hospitalization of the infant within the first year of life after discharge following delivery
Measured: Up to 1 Year of Age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start24 Oct 2018
- Primary completion4 Nov 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies 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
- Prospective
- Enrolment
- 581 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
- NCT04173442
- Sponsor's protocol ID
- R668-AD-1639
- Other IDs
- 43820
- Status last verified
- Feb 2026
- First submitted
- 20 Nov 2019
- Last updated
- 4 Mar 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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Authorization Safety Study to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy in North America
- ClinicalTrials.gov ID
- NCT04173442
- Acronym / sponsor ID
- R668-AD-1639
- Conditions
- Atopic Dermatitis (AD), Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 581 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 22 Nov 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 is to evaluate the potential effect of exposure to dupilumab in pregnancy compared to the primary comparison group of disease-matched pregnant women who are not exposed to dupilumab, and the secondary comparison group of healthy pregnant women.
The primary outcome of the study is major structural defects, and the secondary outcomes of the study are spontaneous abortion/miscarriage, stillbirth, elective termination/abortion, premature delivery, small for gestational age, pattern of 3 or more minor structural defects, postnatal growth of live born children to 1 year of age, postnatal serious or opportunistic infections in live born children to 1 year of age, and hospitalizations in live children up to 1 year of age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Dupilumab-Exposed Cohort | – | Drug: dupilumabPregnant women with approved indications exposed to dupilumab during pregnancy |
| Cohort 2: Disease-Matched Comparison Cohort | – | –Pregnant women with approved indications not exposed to dupilumab during pregnancy |
| Cohort 3: Healthy Comparison Cohort | – | –Pregnant women who are not diagnosed with any dupilumab-approved indications, and not exposed to dupilumab during pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes pregnant women who reside in the US or Canada with dupilumab- exposure for the approved indication, and 2 comparison groups without dupilumab exposure during pregnancy (1 disease-matched unexposed comparison group, and 1 healthy unexposed comparison group).
Key inclusion criteria (9 listed)
- Cohort 1: Dupilumab-Exposed Cohort
- Pregnant women
- Exposure to dupilumab for the treatment of the approved indications of atopic dermatitis (AD) or asthma, for any number of days, at any dose, and at any time from the first day of the LMP up to and including the end of pregnancy.
- Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)
- Pregnant women
Key exclusion criteria (11 listed)
- Cohort 1: Dupilumab-Exposed Cohort
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- Women who have used dupilumab for an indication other than asthma or AD
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- Exposure to dupilumab within 10 weeks of LMP or anytime during the current pregnancy
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®, SAR23189Dupilumab cohort | Drug | Cohort 1: Dupilumab-Exposed Cohort |
Primary outcome
Rate of major structural defects
Time frame: Up to 1 Year of Age
Defined and classified using the Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects
9 secondary outcomes
Incidence of spontaneous abortion or miscarriage
Time frame: Up to 20 weeks post-LMP (Last Menstrual period)
Incidence of stillbirth
Time frame: At or after 20 weeks post-LMP
Incidence of elective termination/abortion
Time frame: Up to 9 months
Incidence of premature delivery
Time frame: Prior to 37 weeks of gestation
Incidence of small for gestational age
Time frame: At Birth
Incidence of a pattern of 3 or more minor structural defects
Time frame: Between Birth and Up to 1 Year of Age
Postnatal growth deficiency
Time frame: Up to 1 Year of Age
Incidence of postnatal serious or opportunistic infections in live born children
Time frame: Up to 1 Year of Age
Incidence of hospitalizations in live born children
Time frame: Up to 1 Year of Age
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 4 Mar 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 Atopic Dermatitis (AD) and Asthma, 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 9 inclusion and 11 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 4 Mar 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?
Rate of major structural defects (time frame: Up to 1 Year of Age). 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 4 Mar 2026.