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

Part of paid clinical trials in Morrisville, North Carolina.

Sponsor
Incyte Corporation
Study ID
NCT06259669
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 13, 2023
Status verified
Dec 2025
Primary completion
Aug 1, 2032
Completion
Aug 1, 2033

Study Design

Enrollment
958 participants (estimated)

Arms

  • Arm: Infants of women exposed to ruxolitinib cream during pregnancy
  • Arm: Infants of women not exposed to ruxolitinib cream during pregnancy

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Syneos Health (remote site)MorrisvilleNorth Carolina27560
Syneos Health
[email protected]
833-917-8791

Find similar trials in Morrisville, NC

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Syneos Health (remote site)· Morrisville, NC

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