Pregnancy RelatedOPERA-1NCT06259669
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 of Pregnancy Related and Atopic Dermatitis, run by Incyte Corporation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Pregnancy Related, Atopic Dermatitis
- What is being tested?
- Ruxolitinib Cream
- How many people
- 958 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2023to 1 Aug 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Syneos Health (remote site)
Morrisville, North Carolina, 27560
Syneos Health, 833-917-8791, opzeluracreampregnancyregistry@syneoshealth.com
About this study
Official title: 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.
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.
- Conditions
- Pregnancy Related, Atopic Dermatitis
- Being tested
- Ruxolitinib Cream
- Keywords
- ruxolitinib, Atopic Dermatitis, pruritus, eczema, topical therapy, JAK inhibitor
- Medical subject headings
- Dermatitis, Atopic, Pruritus, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib CreamDrug
Also called Opzelura
Ruxolitinib Cream
| Study group | Role | What they receive |
|---|---|---|
| Infants of women exposed to ruxolitinib cream during pregnancy | Not described Receives: Drug: Ruxolitinib Cream | |
| Infants of women not exposed to ruxolitinib cream during pregnancy | Not described Receives: Drug: Ruxolitinib Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months after birth
Secondary outcomes (14)
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.
Measured: 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.
Measured: Up to birth
Adverse pregnancy outcomes
Number of preterm births and maternal pregnancy complications as defined in the protocol.
Measured: Up to birth
Gestational Age
Infant Gestational Age at birth as recorded in medical records.
Measured: At time of delivery
Infant Sex
Infant Sex at birth as recorded in the medical records.
Measured: At time of delivery
Infant Body Weight
Infant Body Weight at birth as recorded in medical records.
Measured: At time of delivery
Infant Body Length
Infant Body Length at birth as recorded in medical records.
Measured: At time of delivery
Infant Head Circumference
Infant Head Circumference at birth as recorded in medical records.
Measured: At time of delivery
APGAR Score
One and five minute APGAR Scores at birth as recorded in medical records.
Measured: 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.
Measured: At time of delivery
Infant Body Length
Infant Body Length as recorded in medical records.
Measured: Through 12 months after birth
Infant Body Weight
Infant Body Weight as recorded in medical records.
Measured: Through 12 months after birth
Infant Head Circumference
Infant Head Circumference as recorded in medical records.
Measured: Through 12 months after birth
Abnormal development
Based on Centers for Disease Control and Prevention (CDC) developmental milestones.
Measured: Through 12 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start13 Sep 2023
- Primary completion1 Aug 2032 (estimated)
- Study completion1 Aug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 958 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259669
- Sponsor's protocol ID
- INCB18424-MA-IAI-402
- Acronym
- OPERA-1
- Status last verified
- Dec 2025
- First submitted
- 6 Feb 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06259669
- Acronym / sponsor ID
- OPERA-1 / INCB18424-MA-IAI-402
- Conditions
- Pregnancy Related, Atopic Dermatitis
- Keywords
- ruxolitinib, Atopic Dermatitis, pruritus, eczema, topical therapy, JAK inhibitor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 958 participants (estimated)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 1 Aug 2032 (estimated)
- Study completion
- 1 Aug 2033 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (8 listed)
- 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.
- Reporter (eg, participant, maternal HCP) contact information available to allow for follow-up.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib CreamAlso: OpzeluraRuxolitinib Cream | Drug | Infants of women exposed to ruxolitinib cream during pregnancy, Infants of women not exposed to ruxolitinib cream during pregnancy |
Primary outcome
Number of major congenital malformation (MCM)s
Time frame: Up to 12 months after birth
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.
14 secondary outcomes
Number of minor congenital malformations
Time frame: Up to 12 months after birth
Number of Pregnancy outcomes
Time frame: Up to birth
Adverse pregnancy outcomes
Time frame: Up to birth
Gestational Age
Time frame: At time of delivery
Infant Sex
Time frame: At time of delivery
Infant Body Weight
Time frame: At time of delivery
Infant Body Length
Time frame: At time of delivery
Infant Head Circumference
Time frame: At time of delivery
APGAR Score
Time frame: At time of delivery
Number of small for gestational age (SGA)s
Time frame: At time of delivery
Infant Body Length
Time frame: Through 12 months after birth
Infant Body Weight
Time frame: Through 12 months after birth
Infant Head Circumference
Time frame: Through 12 months after birth
Abnormal development
Time frame: Through 12 months after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 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 (OPERA-1)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Atopic Dermatitis, run by Incyte Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Syneos Health (1.833.917.8791, opzeluracreampregnancyregistry@syneoshealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of major congenital malformation (MCM)s (time frame: Up to 12 months after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.