24 Participants NeededMy employer runs this trial

Povorcitinib + Ruxolitinib for Healthy Subjects

IC
IC
Overseen ByIncyte Corporation Call Center (ex-US)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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.23456

Who Is on the Research Team?

IM

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

I understand the study and am willing to sign a consent form.
I am between 18 and 65 years old.
My body mass index is between 18.0 and 30.5.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of oral povorcitinib or topical ruxolitinib cream

12 days
Daily visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 days
1-2 visits (in-person)

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

Group I: Cohort 3: PovorcitinibExperimental Treatment1 Intervention
Group II: Cohort 2: PovorcitinibExperimental Treatment1 Intervention
Group III: Cohort 1: Ruxolitinib 1.5 % CreamExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Citations

Incyte 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 ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37871805/

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 ...

Povorcitinib 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.

Safety 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 ...