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Clinical Trials in the USA / NCT06259669
Recruiting Observational

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

NCT06259669 · tracked via the Priya Life Science USA tracker
Sponsor
Incyte Corporation
Phase
Observational
Started
2023-09-13
Last updated
2025-12-11

Condition(s) studied

Pregnancy RelatedAtopic Dermatitis

Investigational drug(s) / intervention(s)

Ruxolitinib Cream

Ruxolitinib Cream: Ruxolitinib Cream

Study summary

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.

Eligibility

Sex
FEMALE
Min age
15 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Syneos Health (remote site) Morrisville North Carolina Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06259669 on ClinicalTrials.gov ↗ ← All trials in the USA