Who is eligible for clinical trial NCT06259669?

Participants must meet the protocol's inclusion criteria for Pregnancy Related. The stated age range is 15 Years to 50 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06259669 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-12-04

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)

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

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Incyte Corporation

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (4 items).

Location: Syneos Health (remote site) — Morrisville, North Carolina

Age range: 15 Years to 50 Years

🧪 Interventions in This Study

Ruxolitinib Cream (DRUG)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Syneos Health (remote site) — Morrisville, North Carolina

📞 Contact the Study Coordinator

Phone: (833) 917-8791

Email: opzeluracreampregnancyregistry@syneoshealth.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗