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Observational Study of Ruxolitinib Cream During Pregnancy for Atopic Dermatitis

This study is looking at the health of mothers and babies when ruxolitinib cream is used during pregnancy for mild to moderate atopic dermatitis (a type of eczema). Researchers want to compare the number of major birth defects in babies whose mothers used ruxolitinib cream during pregnancy to babies whose mothers did not. Women aged 15 to 50 with mild to moderate atopic dermatitis can join. You can enroll while you are pregnant or after your baby is born. The study aims to enroll 958 participants. The current recruitment status is unclear.

Study design
This is an observational study comparing women with atopic dermatitis who used ruxolitinib cream during pregnancy to those who did not. It plans to include 958 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will look at major birth defects in babies up to 12 months after birth.

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NCT06259669

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

Recruiting
Not specifiedAges 15–50Observational
Incyte Corporation
~958 participants
Updated 2025-12-11 on ClinicalTrials.gov
What's tested:Ruxolitinib Cream

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of major congenital malformation (MCM)s
Measured over Up to 12 months after birth

Conditions

Pregnancy Related
Atopic Dermatitis

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Atopic Dermatitis

Where it's being run

1 sites across 1 states
North Carolina1

Who to contact

Syneos Health
[email protected]
1.833.917.8791
Email the study team

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Eligibility criteria

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.

What this trial measures

  • Number of major congenital malformation (MCM)sUp to 12 months after birth

    Defined as any major structural or chromosomal defect in live-born infants, stillbirths or spontaneous losses equal to or greater than 20 weeks' gestation, or electively terminated pregnancies of any gestational age.