RecruitingNCT06259669

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

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

Sponsor

Incyte Corporation

Enrollment

958 participants

Start Date

Sep 13, 2023

Study Type

OBSERVATIONAL

Conditions

Atopic Dermatitis Pregnancy Related

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: FEMALEMin Age: 15 YearsMax Age: 50 Years

Inclusion Criteria8

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 Criteria3

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.

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