Povorcitinib + Ruxolitinib for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how two treatments, povorcitinib and ruxolitinib cream, behave in the bodies of healthy adults. Researchers will examine absorption and distribution using a special device and blood samples. The study involves two groups: one applying ruxolitinib cream and the other taking povorcitinib orally. It is best suited for healthy individuals aged 18 to 65 without major health issues such as heart or autoimmune diseases. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications?
Yes, you will need to stop taking prescription drugs within 14 days and nonprescription medications within 7 days before the study treatment, except for occasional use of standard dose paracetamol, acetaminophen, ibuprofen, and standard dose vitamins.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that ruxolitinib cream is well tolerated, meaning it is generally safe to use. Reports indicate no significant systemic side effects. The cream primarily treats skin conditions like atopic dermatitis, with any side effects usually being mild and localized to the application area.
Research on povorcitinib shows it is generally safe for use. Its safety remains consistent over time, with no increase in serious side effects. However, like many similar treatments, rare risks such as blood clots or infections exist.
Both treatments have undergone extensive study, and evidence suggests they are well tolerated when used as directed.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Povorcitinib and Ruxolitinib cream because they offer novel approaches to treatment. Povorcitinib stands out for its targeted action as a Janus kinase (JAK) inhibitor, which helps to modulate the immune response differently from traditional treatments. Meanwhile, Ruxolitinib cream provides a topical application, which is less common in current options and could potentially reduce systemic side effects while directly addressing skin conditions. These treatments bring fresh mechanisms and application methods, promising more tailored and potentially effective solutions.
What evidence suggests that this trial's treatments could be effective?
Research has shown that ruxolitinib cream, a medication applied to the skin, effectively reduces inflammation and itching in conditions like atopic dermatitis. Multiple studies have demonstrated its strong anti-inflammatory effects, and patients tolerate it well. In this trial, some participants will receive ruxolitinib cream.
For povorcitinib, a pill targeting inflammation, studies have demonstrated its ability to improve symptoms in conditions like hidradenitis suppurativa, a long-term skin disease. Povorcitinib consistently reduced inflammatory skin lesions and was well tolerated over time. Other participants in this trial will receive povorcitinib. Both treatments show promising results in managing inflammatory skin conditions.23456Who Is on the Research Team?
Incyte Medical Monitor
Principal Investigator
Incyte Corporation
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18 to 65 with a BMI between 18.0 and 30.5, no significant health issues, able to swallow pills, willing to avoid pregnancy during the study, and able to give informed consent.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive multiple doses of oral povorcitinib or topical ruxolitinib cream
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Povorcitinib
- Ruxolitinib Cream
Trial Overview
The study compares how the body absorbs and processes multiple doses of an oral drug (povorcitinib) versus a topical cream (ruxolitinib) in healthy volunteers using special monitoring devices.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Povorcitinib will be administered at the protocol defined dose.
Povorcitinib will be administered at the protocol defined dose.
Ruxolitinib cream applied topically twice daily.
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
1.
investor.incyte.com
investor.incyte.com/news-releases/news-release-details/incyte-announces-new-positive-54-week-late-breaking-dataIncyte Announces New Positive 54-Week Late-Breaking Data ...
Povorcitinib treatment led to consistent reductions across key inflammatory lesion types, with full resolution (ANdT=0) achieved in up to 20% of ...
Efficacy and safety of the oral Janus kinase 1 inhibitor ...
Povorcitinib demonstrated efficacy in HS, with no evidence of increased incidence of adverse events among doses.
Efficacy and safety of the oral Janus kinase 1 inhibitor ...
Two proof-of-concept phase 2 studies demonstrated that povorcitinib was associated with improved outcomes and was generally well tolerated in patients with ...
4.
docwirenews.com
docwirenews.com/post/long-term-data-on-povorcitinib-for-moderate-to-severe-hidradenitis-suppurativaPovorcitinib for Hidradenitis Suppurativa
Phase 3 data revealed that povorcitinib had durable efficacy and manageable safety in the treatment of hidradenitis suppurativa.
NCT06212999 | A Study to Evaluate the Long-Term Safety ...
The purpose of this study is to evaluate long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa.
6.
incytemi.com
incytemi.com/document/Poster/SHSA%202024_Sayed_84-Week%20Safety%20Phase%202%20Povo%20in%20HS%20Study%20(3000368).pdfSafety of Povorcitinib During 84 Weeks of Treatment
Efficacy and safety of the Janus kinase. 1 inhibitor povorcitinib (INCB054707) in patients with hidradenitis suppurativa: results from a ...
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