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

Study on Pregnancy and Infant Outcomes with Investigational Medication Exposure

Recruiting
18 years or above
Female
Phase N/A
500 participants needed
1 Location

Study Overview

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Atopic Dermatitis (AD), Asthma
  • Age: 18 years or above
  • Gender: Female

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

This study investigates pregnancy and infant outcomes in women exposed to an investigational medication during pregnancy. The study compares these outcomes with those of two other groups: pregnant women with similar health conditions who are not exposed to the investigational medication, and healthy pregnant women. The primary focus is on major structural defects in infants, while secondary outcomes include miscarriage, stillbirth, premature delivery, and postnatal growth and health of infants up to one year of age.

Participants in the study will be monitored to assess the outcomes of their pregnancies and the health of their infants. The study will involve collecting data on the health conditions of the mothers and their exposure to the investigational medication, as well as tracking the development and health of the infants over the first year of life. This data collection will help researchers understand the potential effects of the investigational medication on pregnancy and infant health.

  • Who can participate: Pregnant women who are exposed to the investigational medication for specific health conditions, or have similar conditions without exposure, or are healthy can participate. Key factors include no prenatal diagnosis of major structural defects and no exposure to the investigational medication within specified timeframes for certain groups.
  • Study details: Participants will need to provide health information and undergo regular monitoring throughout their pregnancy and the first year of their infant's life. The study focuses on comparing outcomes between those exposed to the investigational medication and those who are not.
Updated on 28 May 2025. Study ID: NCT04173442

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