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NCT04173442 | RECRUITING | Atopic Dermatitis (AD)

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

Regeneron Pharmaceuticals

Brief Summary:

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.

Condition or disease

Atopic Dermatitis (AD)

Asthma

Intervention/treatment

dupilumab

Study Type : OBSERVATIONAL
Estimated Enrollment : 500 participants
Official Title : Post-Authorization Safety Study to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy in North America
Actual Study Start Date : 2018-10-24
Estimated Primary Completion Date : 2026-01-30
Estimated Study Completion Date : 2026-01-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
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
Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy

Location Details

NCT04173442

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Locations

RECRUITING

United States, California

Regeneron Research Site

La Jolla, California, United States, 92093-0934