Clinical trial NCT04173442: Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy
Official title: Post-Authorization Safety Study to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy in North America
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis (AD)
Asthma
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2019-11-22
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes pregnant women who reside in the US or Canada with dupilumab- exposure for the approved indication, and 2 comparison groups without dupilumab exposure during pregnancy (1 disease-matched unexposed comparison group, and 1 healthy unexposed comparison group).

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.


Eligibility 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

Primary outcomes:
measure: Rate of major structural defects
timeFrame: Up to 1 Year of Age
Secondary outcomes:
measure: Incidence of spontaneous abortion or miscarriage
timeFrame: Up to 20 weeks post-LMP (Last Menstrual period)
measure: Incidence of stillbirth
timeFrame: At or after 20 weeks post-LMP
measure: Incidence of elective termination/abortion
timeFrame: Up to 9 months
measure: Incidence of premature delivery
timeFrame: Prior to 37 weeks of gestation
measure: Incidence of small for gestational age
timeFrame: At Birth
measure: Incidence of a pattern of 3 or more minor structural defects
timeFrame: Between Birth and Up to 1 Year of Age
measure: Postnatal growth deficiency
timeFrame: Up to 1 Year of Age
measure: Incidence of postnatal serious or opportunistic infections in live born children
timeFrame: Up to 1 Year of Age
measure: Incidence of hospitalizations in live born children
timeFrame: Up to 1 Year of Age
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Regeneron Research Site
state: California
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: