Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy

Launched by REGENERON PHARMACEUTICALS · Nov 20, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a medication called dupilumab when taken during pregnancy. The goal is to understand how exposure to dupilumab affects pregnancy and infant health, especially looking for major birth defects and other outcomes like miscarriages, stillbirths, and the overall growth and health of babies in their first year. The study compares pregnant women who have taken dupilumab for conditions like atopic dermatitis (a skin condition) or asthma with two other groups: one group of pregnant women who have similar health issues but haven’t taken dupilumab, and another group of healthy pregnant women.

To be eligible for the study, a woman must be pregnant and fall into one of three groups: those who have taken dupilumab during their pregnancy, those with similar health problems but who have not taken the medication, and healthy pregnant women. Participants can expect to share information about their health and pregnancy, and they will be monitored to see how their pregnancy progresses and how their babies develop. It's important to note that certain criteria may exclude women from participating, such as having been diagnosed with major birth defects before joining the study. This research aims to provide valuable insights into the safety of dupilumab during pregnancy, helping to guide future treatment decisions for expectant mothers.

Gender

FEMALE

Eligibility criteria

• Key Inclusion Criteria:
• • 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
• Key Exclusion Criteria:
• • 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
• 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