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

NCT04173442 | Completed FDA Drug

• 2 other identifiers: R668-AD-163943820
• Study Type: observational
• Target: 581
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis (AD); Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Incidence of spontaneous abortion or miscarriage

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

• Incidence of stillbirth

  At or after 20 weeks post-LMP

• Incidence of elective termination/abortion

  Up to 9 months

• Incidence of premature delivery

  Prior to 37 weeks of gestation

• Incidence of small for gestational age

  At Birth

Study Arms (3)

Cohort 1: Dupilumab-Exposed Cohort

Pregnant women with approved indications exposed to dupilumab during pregnancy

Drug: dupilumab

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

Interventions

dupilumab DRUG

Dupilumab cohort

Also known as: REGN668, Dupixent®, SAR23189

Cohort 1: Dupilumab-Exposed Cohort

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (1)

Regeneron Research Site

La Jolla, California, 92093-0934, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Asthma

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 22, 2019
• Study Start: October 24, 2018
• Primary Completion: November 4, 2025
• Study Completion: November 4, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)