ClinicalTrials.gg
RecruitingNCT06259669OPERA-1Updated Dec 11, 2025

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

An observational study in Pregnancy Related and Atopic Dermatitis, sponsored by Incyte Corporation. Recruiting at 1 site in United States. Open to female participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-12-11.

Sponsored by Incyte Corporation · Observational

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 2 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
958
Ages
15 Years to 50 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 17 studies in Dermatitis, Atopic by Incyte Corporation — 2 open to participants now, 3 under way, 1 of them phase 3. Dermatitis, Atopic · Incyte Corporation.

Started
2023
with 3 others
Observational
3 of 17
2 open now
Registered
14th of 17
by date

Among the 17 studies in Dermatitis, Atopic by Incyte Corporation, this one is one of 4 that started in 2023, is one of 3 observational ones, and was the 14th registered.

Dermatitis, Atopic

1,592 studies on the registry are indexed under Dermatitis, Atopic; 287 are open to participants now.

Browse Dermatitis, Atopic studies →

Open to participants now

2 of the 17 studies in Dermatitis, Atopic by Incyte Corporation are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Who these studies take

Of the 195 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 96 (49%) stop at 75 or younger; 94 take children under 18; 52 take healthy volunteers.

This study: 15 Years to 50 Years · female · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Pregnancy Related
  • Atopic Dermatitis

Keywords

  • ruxolitinib
  • Atopic Dermatitis
  • pruritus
  • eczema
  • topical therapy
  • JAK inhibitor
04

Who can participate

Ages eligible
15 Years to 50 Years
Sexes eligible
Female
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women, aged 15 to 50 years, with confirmed diagnosis of mild to moderate AD.
  • Ability to comprehend and willingness to give 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

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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
958 participants (estimated)
Patient registry
No

Groups and cohorts

  • Infants of women exposed to ruxolitinib cream during pregnancy

    Drug: Ruxolitinib Cream

  • Infants of women not exposed to ruxolitinib cream during pregnancy

    Drug: Ruxolitinib Cream

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 12 months after birth

Secondary outcomes

  1. 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.

    Time frame: Up to 12 months after birth

  2. Number of Pregnancy outcomes

    Number of live births, still births, recognized spontaneous abortions and number of elective terminations as defined in the protocol.

    Time frame: Up to birth

  3. Adverse pregnancy outcomes

    Number of preterm births and maternal pregnancy complications as defined in the protocol.

    Time frame: Up to birth

  4. Gestational Age

    Infant Gestational Age at birth as recorded in medical records.

    Time frame: At time of delivery

  5. Infant Sex

    Infant Sex at birth as recorded in the medical records.

    Time frame: At time of delivery

  6. Infant Body Weight

    Infant Body Weight at birth as recorded in medical records.

    Time frame: At time of delivery

  7. Infant Body Length

    Infant Body Length at birth as recorded in medical records.

    Time frame: At time of delivery

  8. Infant Head Circumference

    Infant Head Circumference at birth as recorded in medical records.

    Time frame: At time of delivery

  9. APGAR Score

    One and five minute APGAR Scores at birth as recorded in medical records.

    Time frame: At time of delivery

  10. Number of small for gestational age (SGA)s

    Defined as a birthweight at or below the 10th percentile for a given gestational age.

    Time frame: At time of delivery

  11. Infant Body Length

    Infant Body Length as recorded in medical records.

    Time frame: Through 12 months after birth

  12. Infant Body Weight

    Infant Body Weight as recorded in medical records.

    Time frame: Through 12 months after birth

  13. Infant Head Circumference

    Infant Head Circumference as recorded in medical records.

    Time frame: Through 12 months after birth

  14. Abnormal development

    Based on Centers for Disease Control and Prevention (CDC) developmental milestones.

    Time frame: Through 12 months after birth

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Aug 2032, 106 months after the start.

Of 74 industry-sponsored observational studies under Dermatitis, Atopic, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 84. This study's planned 106 months is above that.

Counting every sponsor, half of 171 studies reached it within 35 months; a quarter within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2024
First posted
Feb 14, 2024
StartActual
Sep 13, 2023
Primary completionEst.
Aug 1, 2032
CompletionEst.
Aug 1, 2033
Last update
Dec 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06259669
Lead sponsor
Incyte Corporation
Responsible party
Sponsor
First posted
Feb 14, 2024
Start date
Sep 13, 2023
Primary completion
Aug 1, 2032 (estimated)
Completion
Aug 1, 2033 (estimated)
Last update
Dec 11, 2025

Study contacts

Syneos Health
Contact
opzeluracreampregnancyregistry@syneoshealth.com
1.833.917.8791
Incyte Corporation Call Center (US)
Contact
medinfo@incyte.com
1.855.463.3463

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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