Follows pregnant women with eczema who use ruxolitinib cream
Compares outcomes in babies of pregnant women using ruxolitinib cream.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Morrisville, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 15 and 50 years old?
Source: NCT06259669, who can take part
Where in United States
- Syneos Health (remote site)Morrisville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Incyte Corporation
- Trial code
- NCT06259669
- Record updated
- 11 December 2025
- Original description
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.Read full original descriptionShow less
A US-Prospective, Registry-Based, Observational, Exposure Cohort 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
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.
Inclusion: Women, aged 15 to 50 years, with confirmed diagnosis of mild to moderate AD; Ability to comprehend and willingness to give informed consent for the study; a legal minor needs parental or legally authorized representative's consent; Prospective enrollment (ie, enrollment into the registry while the pregnancy is ongoing) or retrospective enrollment (ie, enrollment into the registry within 12 months of pregnancy outcome); Information available to confirm eligibility for either the exposed to ruxolitinib cream cohort or the not exposed to ruxolitinib cream cohort; Ruxolitinib cream cohort: consisting of pregnancies in women with AD and exposure to at least 1 application of ruxolitinib cream during the pregnancy period; Nonexposed cohort: consisting of pregnancies in women with AD but not exposed to ruxolitinib cream during the pregnancy period; Reporter (eg, participant, maternal HCP) contact information available to allow for follow-up; Permission to contact the participant's and her infant's HCPs.
Exclusion: If no longer pregnant and pregnancy outcome occurred more than 12 months prior to enrollment; Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before enrollment with another investigational medication or current enrollment in another investigational drug study; Any pregnancy that is exposed to any other JAK inhibitor from 5 half-lives for the specific JAK inhibitor used from LMP through the end of the first trimester for MCMs or end of pregnancy for other outcomes.