NCT06259669 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
| NCT ID | NCT06259669 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Incyte Corporation |
| Condition | Pregnancy Related |
| Study Type | OBSERVATIONAL |
| Enrollment | 958 participants |
| Start Date | 2023-09-13 |
| Primary Completion | 2032-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 958 participants in total. It began in 2023-09-13 with a primary completion date of 2032-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06259669 clinical trial?
This trial is open to female participants only, aged 15 Years or older, up to 50 Years, studying Pregnancy Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06259669 currently recruiting?
Yes, NCT06259669 is actively recruiting participants. Contact the research team at opzeluracreampregnancyregistry@syneoshealth.com for enrollment information.
Where is the NCT06259669 trial being conducted?
This trial is being conducted at Morrisville, United States.
Who is sponsoring the NCT06259669 clinical trial?
NCT06259669 is sponsored by Incyte Corporation. The trial plans to enroll 958 participants.