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

Part of paid clinical trials in La Jolla, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT04173442
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 24, 2018
Status verified
Feb 2026
Primary completion
Nov 4, 2025
Completion
Nov 4, 2025

Study Design

Enrollment
581 participants (actual)

Arms

  • Arm: Cohort 1: Dupilumab-Exposed Cohort
    Pregnant women with approved indications exposed to dupilumab during pregnancy
  • Arm: Cohort 2: Disease-Matched Comparison Cohort
    Pregnant women with approved indications not exposed to dupilumab during pregnancy
  • Arm: Cohort 3: Healthy Comparison Cohort
    Pregnant women who are not diagnosed with any dupilumab-approved indications, and not exposed to dupilumab during pregnancy

Primary Outcome Measure

Rate of major structural defects [ Time Frame: Up to 1 Year of Age ]

Locations (1)

FacilityCityStateZIPSite coordinators
Regeneron Research SiteLa JollaCalifornia92093-0934-

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