Pregnancy RelatedNCT06627335
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis
An observational study of Pregnancy Related and Atopic Dermatitis, run by Incyte Corporation at 1 site in United States.
Trial summary
This study is to assess infant outcomes of women with AD who were exposed to ruxolitinib cream during pregnancy compared with a control cohort of women with AD who were exposed to a topical corticosteroid (TCS) during pregnancy. Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Pregnancy Related, Atopic Dermatitis
- What is being tested?
- Ruxolitinib Cream and TCS
- How many people
- 5,621 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 15 Aug 2028
- 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 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older 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 14 years or older at pregnancy outcome.
- Pregnancy following FDA approval of ruxolitinib cream for AD on 21 SEP 2021.
- At least 1 pharmacy-dispensing claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort).
- A diagnosis of AD prior to or on the day of the first pharmacy claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort) from 6 months before the estimated date of conception.
- Continuous enrollment in the database from 6 months before the estimated date of conception through the end of pregnancy.
- For infant outcomes only, linkage of mother and infant data will be required (ie, pregnancies that cannot be linked to an infant will be excluded for infant outcomes but not for pregnancy outcomes). Infants will be followed for as long as they are continuously enrolled in the database up to 1 year after birth (ie, variable follow-up for each infant). A 1-year fixed period of continuous enrollment after birth will not be imposed so as not to introduce survival bias.
Who cannot join
- One or more pharmacy claims for oral ruxolitinib or other JAK inhibitors in the exposure window for a given outcome.
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
About this study
Official title: Pregnancy Outcomes Study of Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis
This study is to assess infant outcomes of women with AD who were exposed to ruxolitinib cream during pregnancy compared with a control cohort of women with AD who were exposed to a topical corticosteroid (TCS) during pregnancy.
- Conditions
- Pregnancy Related, Atopic Dermatitis
- Being tested
- Ruxolitinib Cream, TCS
- 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
TCSDrug
Topical corticosteroid
| Study group | Role | What they receive |
|---|---|---|
| Infants of women with AD exposed to ruxolitinib cream during pregnancy | Not described Receives: Drug: Ruxolitinib Cream | |
| Infants of women with AD exposed to a TCS prior to or during pregnancy | Not described Receives: Drug: TCS |
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 (2)
Number of small-for-gestational age (SGA) births
Defined as a birthweight at or below the 10th percentile for a given gestational age.
Measured: At time of delivery
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start27 Mar 2023
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Aug 2028 (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
- Retrospective
- Enrolment
- 5,621 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627335
- Sponsor's protocol ID
- INCB18424-MA-IAI-403
- Status last verified
- Dec 2025
- First submitted
- 2 Oct 2024
- Last updated
- 11 Dec 2025
- Results posted
- 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
- Pregnancy Outcomes Study of Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis
- ClinicalTrials.gov ID
- NCT06627335
- Acronym / sponsor ID
- INCB18424-MA-IAI-403
- Conditions
- Pregnancy Related, Atopic Dermatitis
- Keywords
- ruxolitinib, Atopic Dermatitis, pruritus, eczema, topical therapy, JAK inhibitor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,621 participants (estimated)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Aug 2028 (estimated)
- First posted
- 4 Oct 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 study is to assess infant outcomes of women with AD who were exposed to ruxolitinib cream during pregnancy compared with a control cohort of women with AD who were exposed to a topical corticosteroid (TCS) during pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants of women with AD exposed to ruxolitinib cream during pregnancy | – | Drug: Ruxolitinib Cream |
| Infants of women with AD exposed to a TCS prior to or during pregnancy | – | Drug: TCS |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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 (6 listed)
- Women aged 14 years or older at pregnancy outcome.
- Pregnancy following FDA approval of ruxolitinib cream for AD on 21 SEP 2021.
- At least 1 pharmacy-dispensing claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort).
- A diagnosis of AD prior to or on the day of the first pharmacy claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort) from 6 months before the estimated date of conception.
- Continuous enrollment in the database from 6 months before the estimated date of conception through the end of pregnancy.
Key exclusion criteria (1 listed)
- One or more pharmacy claims for oral ruxolitinib or other JAK inhibitors in the exposure window for a given outcome.
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 with AD exposed to ruxolitinib cream during pregnancy |
| TCSTopical corticosteroid | Drug | Infants of women with AD exposed to a TCS prior to or 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.
2 secondary outcomes
Number of small-for-gestational age (SGA) births
Time frame: At time of delivery
Number of Pregnancy outcomes
Time frame: Up to 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.
- An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database AnalysisLink 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.
Incyte Medical Monitor study director
Incyte Corporation
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 6 inclusion and 1 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 Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.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.