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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06259669
Other study ID # INCB18424-MA-IAI-402
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 13, 2023
Est. completion date August 1, 2033

Study information

Verified date March 2024
Source Incyte Corporation
Contact Syneos Health
Phone 1.833.917.8791
Email opzeluracreampregnancyregistry@syneoshealth.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

This study is an exposure cohort study of women within the US with AD who were exposed to ruxolitinib cream at any time during their pregnancy period, defined as up to 24 days prior to the estimated date of conception (DOC) through the end of pregnancy, compared with women in the US with Atopic Dermatitis (AD) not exposed to ruxolitinib cream during pregnancy. The DOC is estimated to occur 14 days after the last menstrual period (LMP). Eligible pregnant women may self-enroll or voluntarily be enrolled by their health care provider (HCP) by calling Syneos Health. Enrollment should occur as early in pregnancy as possible.


Recruitment information / eligibility

Status Recruiting
Enrollment 958
Est. completion date August 1, 2033
Est. primary completion date August 1, 2032
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 50 Years
Eligibility 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


Intervention

Drug:
Ruxolitinib Cream
Ruxolitinib Cream

Locations

Country Name City State
United States Syneos Health (remote site) Morrisville North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of major congenital malformation (MCM)s Defined as any major structural or chromosomal defect in live-born infants, stillbirths or spontaneous losses equal to or greater than 20 weeks' gestation, or electively terminated pregnancies of any gestational age. Up to 12 months after birth
Secondary Number of minor congenital malformations Defined as abnormalities that do not significantly affect health and development, and normal variants are ascertained only among those who also have a major defect. Up to 12 months after birth
Secondary Number of Pregnancy outcomes Number of live births, still births, recognized spontaneous abortions and number of elective terminations as defined in the protocol. Up to birth
Secondary Adverse pregnancy outcomes Number of preterm births and maternal pregnancy complications as defined in the protocol. Up to birth
Secondary Gestational Age Infant Gestational Age at birth as recorded in medical records. At time of delivery
Secondary Infant Sex Infant Sex at birth as recorded in the medical records. At time of delivery
Secondary Infant Body Weight Infant Body Weight at birth as recorded in medical records. At time of delivery
Secondary Infant Body Length Infant Body Length at birth as recorded in medical records. At time of delivery
Secondary Infant Head Circumference Infant Head Circumference at birth as recorded in medical records. At time of delivery
Secondary APGAR Score One and five minute APGAR Scores at birth as recorded in medical records. At time of delivery
Secondary Number of small for gestational age (SGA)s Defined as a birthweight at or below the 10th percentile for a given gestational age. At time of delivery
Secondary Infant Body Length Infant Body Length as recorded in medical records. Through 12 months after birth
Secondary Infant Body Weight Infant Body Weight as recorded in medical records. Through 12 months after birth
Secondary Infant Head Circumference Infant Head Circumference as recorded in medical records. Through 12 months after birth
Secondary Abnormal development Based on Centers for Disease Control and Prevention (CDC) developmental milestones. Through 12 months after birth
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