Ruxolitinib Cream for Atopic Dermatitis During Pregnancy
(OPERA-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if using ruxolitinib cream during pregnancy affects newborn health compared to those whose mothers did not use the cream. Ruxolitinib treats atopic dermatitis, a condition causing itchy and inflamed skin, and some women might use it during pregnancy. The study will compare the rates of major congenital malformations (birth defects) in infants from both groups. Women who may be suitable for this trial have been diagnosed with mild to moderate atopic dermatitis and are either using or not using ruxolitinib cream during pregnancy.
As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to important research on treatment safety during pregnancy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those who have used other investigational drugs recently or are currently in another drug study. It also excludes pregnancies exposed to other JAK inhibitors during certain periods.
What prior data suggests that ruxolitinib cream is safe during pregnancy?
Research has shown that ruxolitinib cream is usually safe to use. In earlier studies with animals like rats, no harmful effects on the survival or growth of embryos occurred, even at doses more than three times higher than those for humans. While these results are encouraging, the effects on human pregnancies remain unclear. To learn more, a registry tracks the health of pregnant women using this cream and their babies.12345
Why are researchers excited about this trial?
Researchers are excited about ruxolitinib cream for treating mild to moderate atopic dermatitis during pregnancy because it offers a targeted approach with potentially fewer systemic effects. Unlike standard treatments like topical corticosteroids or calcineurin inhibitors, ruxolitinib is a JAK inhibitor that specifically targets the pathways involved in inflammation. This specificity might lead to better control of symptoms with reduced risk to both mother and fetus. Additionally, the topical application of ruxolitinib cream allows for localized treatment, potentially minimizing exposure to the rest of the body.
What evidence suggests that ruxolitinib cream is safe for use during pregnancy?
Research shows that ruxolitinib cream effectively treats mild to moderate atopic dermatitis, a type of eczema. Studies have found significant skin improvements in people using this cream. More individuals achieved clearer skin with ruxolitinib than those who did not use it. The cream targets specific parts of the immune system, reducing inflammation and itching. While the current study compares infants of women exposed to ruxolitinib cream during pregnancy with those not exposed, earlier research supports the cream's effectiveness in treating eczema.34678
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Exposure
Women with atopic dermatitis are exposed to ruxolitinib cream during pregnancy
Follow-up
Participants are monitored for maternal, fetal, and infant outcomes, including major congenital malformations, up to 12 months after birth
What Are the Treatments Tested in This Trial?
Interventions
- Ruxolitinib Cream
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Incyte Corporation
Lead Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
Citations
An Observational Retrospective Cohort Study Being ...
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 ...
NCT06259669 | Study to Compare Maternal, Fetal, and ...
Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an ...
215309Orig1s000 OTHER REVIEW(S) - accessdata.fda.gov
In a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implantation through lactation at doses ...
4.
investor.incyte.com
investor.incyte.com/news-releases/news-release-details/incyte-announces-positive-topline-results-phase-3-trialIncyte Announces Positive Topline Results from Phase 3 ...
The study met its primary endpoint and showed significantly more patients treated with ruxolitinib cream 0.75% and 1.5% achieved Investigator's ...
Efficacy and safety of ruxolitinib cream for the treatment of ...
There is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA ...
Study to Compare Maternal, Fetal, and Infant Outcomes of ...
Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an ...
Opzelura
The OPZELURA® (ruxolitinib) Cream 1.5% Pregnancy Registry is an observational research study that monitors the pregnancy status and outcomes in participants ...
Side Effects | Atopic Dermatitis
It is not known if OPZELURA will harm your unborn baby. There is a pregnancy exposure registry for individuals who use OPZELURA during pregnancy. The ...
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