Recruiting

Ruxolitinib vs. Topical Corticosteroids

Sponsor:

Incyte Corporation

Code:

NCT06627335

Conditions

Pregnancy Related

Atopic Dermatitis

Eligibility Criteria

Sex: Female

Age: 14+

Healthy Volunteers: Not accepted

Interventions

Ruxolitinib Cream

TCS

Study Details

Brief summary:

This study is to assess infant outcomes of women with AD who were exposed to ruxolitinib cream during pregnancy compared with a control cohort of women with AD who were exposed to a topical corticosteroid (TCS) during pregnancy.

Conditions

Pregnancy Related

Atopic Dermatitis

Study ID

NCT06627335

Start date

Mar 27, 2023

Status verified date

Dec, 2025

Completion date

Aug 15, 2028

Anticipated

Primary completion date

Aug 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women aged 14 years or older at pregnancy outcome.
  • Pregnancy following FDA approval of ruxolitinib cream for AD on 21 SEP 2021.
  • At least 1 pharmacy-dispensing claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort).
  • A diagnosis of AD prior to or on the day of the first pharmacy claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort) from 6 months before the estimated date of conception.
  • Continuous enrollment in the database from 6 months before the estimated date of conception through the end of pregnancy.
  • For infant outcomes only, linkage of mother and infant data will be required (ie, pregnancies that cannot be linked to an infant will be excluded for infant outcomes but not for pregnancy outcomes). Infants will be followed for as long as they are continuously enrolled in the database up to 1 year after birth (ie, variable follow-up for each infant). A 1-year fixed period of continuous enrollment after birth will not be imposed so as not to introduce survival bias.

Exclusion Criteria:

• One or more pharmacy claims for oral ruxolitinib or other JAK inhibitors in the exposure window for a given outcome.

Study Design

Enrollment

5621 participants

Anticipated

Interventions and Outcome Measures

Arms

Infants of women with AD exposed to ruxolitinib cream during pregnancy

Infants of women with AD exposed to a TCS prior to or during pregnancy

Interventions

Ruxolitinib Cream

Ruxolitinib Cream

TCS

Topical corticosteroid

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Locations

Syneos Health (remote site)

Recruiting

Morrisville, North Carolina, United States, 27560

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 2026-10-03. 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.