Comparing outcomes for pregnant women with atopic dermatitis using ruxolitinib cream
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
This study is trying to see if using ruxolitinib cream during pregnancy is safe for women with mild to moderate atopic dermatitis and their babies compared to those who don’t use it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 958 (estimated) |
| Ages | 15 Years to 50 Years |
| Sex | Female |
| Sponsor | Incyte Corporation Industry-sponsored |
| Drugs / interventions | ruxolitinib |
| Locations | 1 site (Morrisville, North Carolina) |
| Trial ID | NCT06259669 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare maternal, fetal, and infant outcomes between women with mild to moderate atopic dermatitis who used ruxolitinib cream during pregnancy and those who did not. The study will enroll women in the US, allowing for both prospective and retrospective enrollment based on their pregnancy outcomes. Participants will be monitored for the frequency of major congenital malformations among infants born to these women. The goal is to gather data that can inform the safety of ruxolitinib cream in pregnant patients.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 15 to 50 years with a confirmed diagnosis of mild to moderate atopic dermatitis.
Not a fit: Patients who are not pregnant or those with severe atopic dermatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of ruxolitinib cream for treating atopic dermatitis during pregnancy.
How similar studies have performed: While there may be limited data on the specific use of ruxolitinib cream during pregnancy, similar observational studies have provided valuable safety data for other treatments in pregnant populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. 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.
Where this trial is running
Morrisville, North Carolina
- Syneos Health (remote site) — Morrisville, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Syneos Health
- Email: opzeluracreampregnancyregistry@syneoshealth.com
- Phone: 1.833.917.8791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.