NCT06259669Recruiting
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
Source: ClinicalTrials.gov · Last updated 11 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 958 (estimated)
- First submitted
- 6 Feb 2024
- Start date
- 13 Sept 2023
- Primary completion date
- 1 Aug 2032
- Lead sponsor
- Incyte Corporation
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06259669
What you commit to
- Study type: Observational
- Planned participants: 958
- From 13 Sept 2023 to the primary completion date, 1 Aug 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 15 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Syneos Health (remote site) Coordinator of this site? Confirm its status | Morrisville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.