Monitoring pregnancy and infant outcomes after dupilumab exposure
Post-Authorization Safety Study to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy in North America
Regeneron Pharmaceuticals · NCT04173442
This study looks at whether using dupilumab during pregnancy affects the health of mothers and their babies compared to those who didn't use it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Regeneron Pharmaceuticals (industry) |
| Drugs / interventions | Dupilumab |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT04173442 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety of dupilumab exposure during pregnancy by comparing outcomes in pregnant women who have been treated with dupilumab for atopic dermatitis or asthma to those who have not been exposed. The study will assess major structural defects and other pregnancy-related outcomes such as miscarriage, stillbirth, and postnatal growth in infants. Participants will be divided into three cohorts: those exposed to dupilumab, disease-matched pregnant women not exposed, and healthy pregnant women. The study will gather data to better understand the implications of dupilumab use during pregnancy.
Who should consider this trial
Good fit: Ideal candidates include pregnant women who have been treated with dupilumab or those diagnosed with moderate-to-severe atopic dermatitis or asthma who have not been exposed to dupilumab.
Not a fit: Patients who are not pregnant or those who have not been diagnosed with atopic dermatitis or asthma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of dupilumab during pregnancy, helping to inform treatment decisions for pregnant women with atopic dermatitis or asthma.
How similar studies have performed: Other studies have explored the safety of medications during pregnancy, but this specific approach to monitoring dupilumab exposure is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
La Jolla, California
- Regeneron Research Site — La Jolla, California, United States (RECRUITING)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atopic Dermatitis, Asthma