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

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

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 Overview

• Status: Completed
• Conditions: Asthma; Atopic Dermatitis (AD)
• Intervention / Treatment: Drug: dupilumab

• Study Type: Observational
• Enrollment (Actual): 581

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093-0934
      • Regeneron Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1: Dupilumab-Exposed Cohort; Pregnant women with approved indications exposed to dupilumab during pregnancy	Drug: dupilumab; Dupilumab cohort; Other Names: REGN668; Dupixent®; SAR23189
Cohort 2: Disease-Matched Comparison Cohort; Pregnant women with approved indications not exposed to dupilumab during pregnancy
Cohort 3: Healthy Comparison Cohort; Pregnant women who are not diagnosed with any dupilumab-approved indications, and not exposed to dupilumab during pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 1 Year of Age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of spontaneous abortion or miscarriage	Defined as non-deliberate fetal death	Up to 20 weeks post-LMP (Last Menstrual period)
Incidence of stillbirth	Defined as non-deliberate fetal death	At or after 20 weeks post-LMP
Incidence of elective termination/abortion	Defined as deliberate discontinuation of pregnancy through medication or surgical procedures	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)	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	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	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.	Up to 1 Year of Age
Incidence of postnatal serious or opportunistic infections in live born children	Defined as any infection resulting in hospitalization	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	Up to 1 Year of Age

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2018
• Primary Completion (Actual): November 4, 2025
• Study Completion (Actual): November 4, 2025

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Asthma; Dermatitis, Atopic; dupilumab
• Other Study ID Numbers: R668-AD-1639; 43820 (Registry Identifier: EU HMA-EMA Catalogue)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No