Asthma, Atopic Dermatitis (AD)
Conditions
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.
Interventions
DRUGdupilumab
Dupilumab cohort
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of major structural defects | Up to 1 Year of Age | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of elective termination/abortion | Up to 9 months | Defined as deliberate discontinuation of pregnancy through medication or surgical procedures |
| Incidence of premature delivery | Prior to 37 weeks of gestation | Defined as live birth prior to 37.0 weeks gestation as counted from LMP (or ultrasound-adjusted date) |
| Incidence of spontaneous abortion or miscarriage | Up to 20 weeks post-LMP (Last Menstrual period) | Defined as non-deliberate fetal death |
| Incidence of small for gestational age | At Birth | 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 |
| Incidence of a pattern of 3 or more minor structural defects | Between Birth and Up to 1 Year of Age | 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 |
| Postnatal growth deficiency | Up to 1 Year of Age | 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. |
| Incidence of postnatal serious or opportunistic infections in live born children | Up to 1 Year of Age | Defined as any infection resulting in hospitalization |
| Incidence of stillbirth | At or after 20 weeks post-LMP | Defined as non-deliberate fetal death |
| Incidence of hospitalizations in live born children | Up to 1 Year of Age | Defined as any hospitalization of the infant within the first year of life after discharge following delivery |
Countries
United States
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed