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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

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

NCT06259669•Incyte Corporation

View on ClinicalTrials.gov

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.

Detailed Description

This study is an exposure cohort study of women within the US with AD who were exposed to ruxolitinib cream at any time during their pregnancy period, defined as up to 24 days prior to the estimated date of conception (DOC) through the end of pregnancy, compared with women in the US with Atopic Dermatitis (AD) not exposed to ruxolitinib cream during pregnancy. The DOC is estimated to occur 14 days after the last menstrual period (LMP). Eligible pregnant women may self-enroll or voluntarily be enrolled by their health care provider (HCP) by calling Syneos Health. Enrollment should occur as early in pregnancy as possible.

Eligibility

Age

15 - 50 years

Sex

FEMALE

Healthy Volunteers

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.

Locations (1)

Syneos Health (remote site)

Morrisville, North Carolina, United States

Key Dates

Start Date

September 13, 2023

Primary Completion Date

August 1, 2032

Completion Date

August 1, 2033

Last Updated

December 11, 2025

Enrollment

958

ESTIMATED participants

Conditions

Pregnancy RelatedAtopic Dermatitis

Interventions

Ruxolitinib Cream

DRUG

Contacts

Syneos Health

CONTACT

1.833.917.8791 opzeluracreampregnancyregistry@syneoshealth.com

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463 medinfo@incyte.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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