RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-10-24

Study Completion:2026-07-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04173442

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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. * Pregnant women	* 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 * 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 * 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

Inclusion Criteria

Exclusion Criteria

* 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.
* 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.
* Pregnant women

* 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
* 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
* 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

Contacts and Locations

Study Contact

Clinical Trials Administrator

CONTACT

844-734-6643

clinicaltrials@regeneron.com

Principal Investigator

Clinical Trial Management

STUDY_DIRECTOR

Regeneron Pharmaceuticals

Study Locations (Sites)

Regeneron Research Site

La Jolla, California, 92093-0934

United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-10-24

Study Completion Date2026-07-09

Study Record Updates

Study Start Date2018-10-24

Study Completion Date2026-07-09

Terms related to this study

Additional Relevant MeSH Terms

Atopic Dermatitis (AD)
Asthma