An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis

Recruiting

• Conditions: Pregnancy Related; Atopic Dermatitis
• Interventions: Drug: Ruxolitinib Cream; Drug: TCS

• Registration Number: NCT06627335
• Lead Sponsor: Incyte Corporation

Brief Summary

This study is to assess infant outcomes of women with AD who were exposed to ruxolitinib cream during pregnancy compared with a control cohort of women with AD who were exposed to a topical corticosteroid (TCS) during pregnancy.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-27
• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Study First Posted: 2024-10-04
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-03
• Primary Completion: 2027-08-15
• Study Completion: 2028-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 5621

Inclusion Criteria

• Women aged 14 years or older at pregnancy outcome.
• Pregnancy following FDA approval of ruxolitinib cream for AD on 21 SEP 2021.
• At least 1 pharmacy-dispensing claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort).
• A diagnosis of AD prior to or on the day of the first pharmacy claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort) from 6 months before the estimated date of conception.
• Continuous enrollment in the database from 6 months before the estimated date of conception through the end of pregnancy.
• For infant outcomes only, linkage of mother and infant data will be required (ie, pregnancies that cannot be linked to an infant will be excluded for infant outcomes but not for pregnancy outcomes). Infants will be followed for as long as they are continuously enrolled in the database up to 1 year after birth (ie, variable follow-up for each infant). A 1-year fixed period of continuous enrollment after birth will not be imposed so as not to introduce survival bias.

Exclusion Criteria

• One or more pharmacy claims for oral ruxolitinib or other JAK inhibitors in the exposure window for a given outcome.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infants of women with AD exposed to ruxolitinib cream during pregnancy	Ruxolitinib Cream	-
Infants of women with AD exposed to a TCS prior to or during pregnancy	TCS	-

Primary Outcome Measures

Name	Time	Method
Number of major congenital malformation (MCM)s	Up 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.

Secondary Outcome Measures

Name	Time	Method
Number of small-for-gestational age (SGA) births	At time of delivery	Defined as a birthweight at or below the 10th percentile for a given gestational age.
Number of Pregnancy outcomes	Up to birth	Number of live births, still births, recognized spontaneous abortions and number of elective terminations as defined in the protocol.

Trial Locations

Locations (1)

Syneos Health (remote site); 🇺🇸 Morrisville, North Carolina, United States