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 | Recruiting FDA Drug

• 1 other identifier: INCB18424-MA-IAI-402
• Study Type: observational
• Target: 958
• Locations: 1 country
• Sites: 1

Brief 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.

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 (14)

• Number of minor congenital malformations

  Up to 12 months after birth

• Number of Pregnancy outcomes

  Up to birth

• Adverse pregnancy outcomes

  Up to birth

• Gestational Age

  At time of delivery

• Infant Sex

  At time of delivery

Study Arms (2)

Infants of women exposed to ruxolitinib cream during pregnancy

Drug: Ruxolitinib Cream

Infants of women not exposed to ruxolitinib cream during pregnancy

Drug: Ruxolitinib Cream

Interventions

Ruxolitinib Cream DRUG

Ruxolitinib Cream

Also known as: Opzelura

Infants of women exposed to ruxolitinib cream during pregnancy; Infants of women not exposed to ruxolitinib cream during pregnancy

Eligibility Criteria

• Age: 15 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Syneos Health (remote site)

Morrisville, North Carolina, 27560, United States

RECRUITING

Related Links

• 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 (OPERA-1)

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

Central Study Contacts

Syneos Health

CONTACT

1.833.917.8791; opzeluracreampregnancyregistry@syneoshealth.com

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Study Design

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

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: September 13, 2023
• Primary Completion (Estimated): August 1, 2032
• Study Completion (Estimated): August 1, 2033
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)