NCT04173442Completed
Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy
Post-Authorization Safety Study to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy in North America
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 581 (actual)
- First submitted
- 20 Nov 2019
- Start date
- Oct 2018
- Primary completion date
- Nov 2025
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Atopic dermatitis (eczema), Asthma
- NCT number
- NCT04173442
What you commit to
- Study type: Observational
- Participants enrolled: 581
- From Oct 2018 to the primary completion date, Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Exposure to dupilumab within 10 weeks prior to the first day of the LMP
Other illness
- Women who have used dupilumab for an indication other than asthma or AD
- Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1):
Other
- Cohort 1: Dupilumab-Exposed Cohort
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- 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
- Cohort 3: Non-Diseased Comparison Cohort (Comparison Group 2):
- 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
Who the study is looking for
- 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.
- 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
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.