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

NCT06627335 | Recruiting FDA Drug

• 1 other identifier: INCB18424-MA-IAI-403
• Study Type: observational
• Target: 5,621
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Atopic Dermatitis

Keywords

ruxolitinib; Atopic Dermatitis; pruritus; eczema; topical therapy; JAK inhibitor

Outcome Measures

Primary Outcomes (1)

• Number of major congenital malformation (MCM)s

  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.

  Up to 12 months after birth

Secondary Outcomes (2)

• Number of small-for-gestational age (SGA) births

  At time of delivery

• Number of Pregnancy outcomes

  Up to birth

Study Arms (2)

Infants of women with AD exposed to ruxolitinib cream during pregnancy

Drug: Ruxolitinib Cream

Infants of women with AD exposed to a TCS prior to or during pregnancy

Drug: TCS

Interventions

Ruxolitinib Cream DRUG

Ruxolitinib Cream

Also known as: Opzelura

Infants of women with AD exposed to ruxolitinib cream during pregnancy

TCS DRUG

Topical corticosteroid

Infants of women with AD exposed to a TCS prior to or during pregnancy

Eligibility Criteria

• Age: 14 Years+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Exposure cohort study of women within the US with atopic dermatitis (AD) who were exposed to ruxolitinib cream at any time during their pregnancy period.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Syneos Health (remote site)

Morrisville, North Carolina, 27560, United States

RECRUITING

Related Links

• 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

MeSH Terms

Conditions

Dermatitis, Atopic; Pruritus; Eczema

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 4, 2024
• Study Start: March 27, 2023
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 15, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)