Recruiting

Ruxolitinib Cream

Sponsor:

Incyte Corporation

Code:

NCT06259669

Conditions

Pregnancy Related

Atopic Dermatitis

Eligibility Criteria

Sex: Female

Age: 15 - 50

Healthy Volunteers: Not accepted

Interventions

Ruxolitinib Cream

Study Details

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.

Conditions

Pregnancy Related

Atopic Dermatitis

Study ID

NCT06259669

Start date

Sep 13, 2023

Status verified date

Dec, 2025

Completion date

Aug 1, 2033

Anticipated

Primary completion date

Aug 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15 - 50

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

958 participants

Anticipated

Interventions and Outcome Measures

Arms

Infants of women exposed to ruxolitinib cream during pregnancy

Infants of women not exposed to ruxolitinib cream during pregnancy

Interventions

Ruxolitinib Cream

Ruxolitinib Cream

Primary outcome measure

  • Number of major congenital malformation (MCM)s [ Time Frame: Up to 12 months after birth ]

Central Contacts and Locations

Central contacts

Syneos Health

1.833.917.8791opzeluracreampregnancyregistry@syneoshealth.com

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Locations

Syneos Health (remote site)

Recruiting

Morrisville, North Carolina, United States, 27560

Contacts

Syneos Health

833-917-8791opzeluracreampregnancyregistry@syneoshealth.com

More Information

Sponsor

Incyte Corporation

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Keywords

  • ruxolitinib
  • Atopic Dermatitis
  • pruritus
  • eczema
  • topical therapy
  • JAK inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2025-12-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.