Actively Recruiting
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Led by Regeneron Pharmaceuticals · Updated on 2025-08-03
3930
Participants Needed
1
Research Sites
381 weeks
Total Duration
On this page
Sponsors
R
Regeneron Pharmaceuticals
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion/miscarriage, stillbirth) and prevalence of adverse infant outcomes (major congenital malformations \[MCMs\], small for gestational age \[SGA\]) in women with AD who are treated with dupilumab during pregnancy relative to women with AD who are not treated with dupilumab during pregnancy.
CONDITIONS
Official Title
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Continuous medical and pharmacy benefit coverage for at minimum 6 months prior to and including the estimated last menstrual period
- Diagnosis code indicative of atopic dermatitis in the period from up to 1 year prior to the estimated last menstrual period through the end of the pregnancy
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Regeneron Research Site
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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