Actively Recruiting
Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population
Led by Incyte Corporation · Updated on 2025-12-11
958
Participants Needed
1
Research Sites
515 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational (enrollment into the registry while the pregnancy is ongoing) study is being conducted to compare the frequency of major congenital malformation (MCM)s among infants of women exposed to ruxolitinib cream during pregnancy with infants of women not exposed to ruxolitinib cream during pregnancy.
CONDITIONS
Official Title
Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 15 to 50 years with a confirmed diagnosis of mild to moderate atopic dermatitis
- Ability to understand and willing to provide informed consent; legal minors need parental or authorized representative consent
- Enrollment during pregnancy (prospective) or within 12 months after pregnancy outcome (retrospective)
- Information available to confirm exposure status to ruxolitinib cream during pregnancy
- Contact information available for follow-up with participant and their healthcare providers
- Permission granted to contact participant's and infant's healthcare providers
You will not qualify if you...
- Pregnancy outcome occurred more than 12 months before enrollment if no longer pregnant
- Current or recent (within 30 days or 5 half-lives) treatment with another investigational medication or enrollment in another investigational drug study
- Exposure to any other JAK inhibitor from 5 half-lives before last menstrual period through the end of the first trimester (for major congenital malformations) or end of pregnancy (for other outcomes)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Syneos Health (remote site)
Morrisville, North Carolina, United States, 27560
Actively Recruiting
Research Team
S
Syneos Health
CONTACT
I
Incyte Corporation Call Center (US)
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
2
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