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 (OPERA-1)

A US-Prospective, Registry-Based, Observational, Exposure Cohort 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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; Atopic Dermatitis
• Intervention / Treatment: Drug: Ruxolitinib Cream

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 958

Contacts and Locations

• Study Contact: Name: Incyte Corporation Call Center (US); Phone Number: 1.855.463.3463; Email: medinfo@incyte.com
• Study Contact Backup: Name: Syneos Health; Phone Number: 1.833.917.8791; Email: opzeluracreampregnancyregistry@syneoshealth.com

Study Locations

• United States
  • North Carolina
    • Morrisville, North Carolina, United States, 27560
      • Recruiting
      • Syneos Health (remote site)
      • Contact: Syneos Health; Phone Number: 833-917-8791; Email: opzeluracreampregnancyregistry@syneoshealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Exposure cohort study of women within the US with atopic dermatitis (AD) who were exposed to ruxolitinib cream at any time during their pregnancy period.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infants of women exposed to ruxolitinib cream during pregnancy	Drug: Ruxolitinib Cream; Ruxolitinib Cream; Other Names: Opzelura
Infants of women not exposed to ruxolitinib cream during pregnancy	Drug: Ruxolitinib Cream; Ruxolitinib Cream; Other Names: Opzelura

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Adverse pregnancy outcomes	Number of preterm births and maternal pregnancy complications as defined in the protocol.	Up to birth
Gestational Age	Infant Gestational Age at birth as recorded in medical records.	At time of delivery
Infant Sex	Infant Sex at birth as recorded in the medical records.	At time of delivery
Infant Body Weight	Infant Body Weight at birth as recorded in medical records.	At time of delivery
Infant Body Length	Infant Body Length at birth as recorded in medical records.	At time of delivery
Infant Head Circumference	Infant Head Circumference at birth as recorded in medical records.	At time of delivery
APGAR Score	One and five minute APGAR Scores at birth as recorded in medical records.	At time of delivery
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
Infant Body Length	Infant Body Length as recorded in medical records.	Through 12 months after birth
Infant Body Weight	Infant Body Weight as recorded in medical records.	Through 12 months after birth
Infant Head Circumference	Infant Head Circumference as recorded in medical records.	Through 12 months after birth
Abnormal development	Based on Centers for Disease Control and Prevention (CDC) developmental milestones.	Through 12 months after birth

Collaborators and Investigators

• Sponsor: Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Estimated): August 1, 2032
• Study Completion (Estimated): August 1, 2033

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: eczema; topical therapy; pruritus; Atopic Dermatitis; JAK inhibitor; ruxolitinib
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: INCB18424-MA-IAI-402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No