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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.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Cohort 1: Dupilumab-Exposed Cohort
Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)
Cohort 3: Healthy Comparison Cohort (Comparison Group 2):
Key Exclusion Criteria:
Cohort 1: Dupilumab-Exposed Cohort
Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1):
Cohort 3: Non-Diseased Comparison Cohort (Comparison Group 2):
NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
300 participants in 3 patient groups
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Clinical Trials Administrator
Data sourced from clinicaltrials.gov
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