ClinicalTrials.gg
RecruitingNCT06627335Updated Dec 11, 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 Analysis

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 14 Years and older. Per ClinicalTrials.gov, last updated 2025-12-11.

Sponsored by Incyte Corporation · Observational

From the registry’s dates

  • Started Mar 2023; still recruiting 3 years 7 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
5,621
Ages
14 Years and older
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
15th 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 15th 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: 14 Years and older · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Get alerts for this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 17 studies in Dermatitis, Atopic by Incyte Corporation, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Pregnancy Related
  • Atopic Dermatitis

Keywords

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

Who can participate

Ages eligible
14 Years and older
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 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.

Exclusion criteria

Exclusion Criteria:

  • One or more pharmacy claims for oral ruxolitinib or other JAK inhibitors in the exposure window for a given outcome.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
5,621 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Ruxolitinib Cream

    Also known as: Opzelura

  • DrugTCS

    Topical corticosteroid

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 small-for-gestational age (SGA) births

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

    Time frame: At time of delivery

  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

07

Study locations

1 of 1 sites recruiting
  • Syneos Health (remote site)
    Morrisville, North Carolina 27560, United States
    Recruiting
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2023 (actual). Primary completion is estimated for Aug 2027, 52 months after the start.

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

Registered
Oct 2, 2024
First posted
Oct 4, 2024
StartActual
Mar 27, 2023
Primary completionEst.
Aug 15, 2027
CompletionEst.
Aug 15, 2028
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
NCT06627335
Lead sponsor
Incyte Corporation
Responsible party
Sponsor
First posted
Oct 4, 2024
Start date
Mar 27, 2023
Primary completion
Aug 15, 2027 (estimated)
Completion
Aug 15, 2028 (estimated)
Last update
Dec 11, 2025

Study contacts

Incyte Corporation Call Center (US)
Contact
medinfo@incyte.com
1.855.463.3463
Incyte Medical Monitor
study director · Incyte Corporation

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion