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Follows pregnant women with eczema who use ruxolitinib cream

Compares outcomes in babies of pregnant women using ruxolitinib cream.

Key facts

Who runs it
Incyte Corporation
Where
Morrisville, United StatesSee the site
Trial code
Registry title
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
Status
Recruiting
People taking part
958 people, planned
Started
13 Sept 2023
Expected to end
1 Aug 2033
Type of study
Observational, 2 groups
Treatments tested
  • Ruxolitinib Cream
Record updated
11 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women with mild to moderate atopic dermatitis who are pregnant or were pregnant in the last 12 months. It compares women who used ruxolitinib cream with women who did not.

Age
15 to 50 years
Sex
Women only
Disease stage
Mild to moderate atopic dermatitis (AD), confirmed by diagnosis
Earlier treatment
One group used ruxolitinib cream at least once during pregnancy. The other group did not use it. No other JAK inhibitor during the pregnancy.

Main reasons for not taking part

  • Pregnancy ended more than 12 months before enrollment
  • Another investigational medication within 30 days or 5 half-lives before enrollment, whichever is longer
  • Currently in another investigational drug study
  • Exposure to any other JAK inhibitor during the pregnancy

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 15 and 50 years old?

Where in United States

  • Syneos Health (remote site)Morrisville, United StatesContact: Syneos HealthTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Infants of women exposed to ruxolitinib cream during pregnancy

    Treatment: Ruxolitinib Cream

  • Infants of women not exposed to ruxolitinib cream during pregnancy

    Treatment: Ruxolitinib Cream

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Follows pregnant women with eczema who use ruxolitinib creamGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06259669, who can take part
Record updated
11 December 2025