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

Regeneron Pharmaceuticals500 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Atopic Dermatitis (AD)Asthma

Interventions

dupilumabDRUG

Dupilumab cohort

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Rate of major structural defects

Defined and classified using the Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects

Time frame: Up to 1 Year of Age

Secondary Outcomes

Incidence of spontaneous abortion or miscarriage

Defined as non-deliberate fetal death

Time frame: Up to 20 weeks post-LMP (Last Menstrual period)

Incidence of stillbirth

Defined as non-deliberate fetal death

Time frame: At or after 20 weeks post-LMP

Incidence of elective termination/abortion

Defined as deliberate discontinuation of pregnancy through medication or surgical procedures

Time frame: Up to 9 months

Incidence of premature delivery

Defined as live birth prior to 37.0 weeks gestation as counted from LMP (or ultrasound-adjusted date)

Time frame: Prior to 37 weeks of gestation

Incidence of small for gestational age

Defined as birth size (weight, length or head circumference) less than or equal to the 10th centile for sex and gestational age using standard pediatric CDC growth curves for full term or preterm infants

Time frame: At Birth

Incidence of a pattern of 3 or more minor structural defects

Identified by a study examiner: Defined as 1 of the defects representing a structural anomaly which has neither cosmetic nor functional significance to the child

Time frame: Between Birth and Up to 1 Year of Age

Postnatal growth deficiency

Defined as postnatal size (weight, length or head circumference) less than or equal to the 10th centile for sex and age using standard pediatric growth curves, and adjusted for postnatal age for premature infants if the postnatal measurement is obtained at less than 1 year of age.

Time frame: Up to 1 Year of Age

Incidence of postnatal serious or opportunistic infections in live born children

Defined as any infection resulting in hospitalization

Time frame: Up to 1 Year of Age

Incidence of hospitalizations in live born children

Defined as any hospitalization of the infant within the first year of life after discharge following delivery

Time frame: Up to 1 Year of Age

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts