Povorcitinib for Prurigo Nodularis

Recruiting in Palo Alto (17 mi)

+143 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Incyte Corporation

Must not be taking: JAK inhibitors, TYK2 inhibitors

Disqualifiers: Pregnancy, Cardiovascular diseases, Infections, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is Povorcitinib safe for humans?

Povorcitinib, also known as INCB-054707, is being studied for safety in clinical trials for conditions like prurigo nodularis. While specific safety data for Povorcitinib is not detailed in the provided research, it is mentioned as a small molecule under investigation, suggesting ongoing evaluation of its safety profile. ^{1 2 3 4 5}

Research Team

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Eligibility Criteria

This trial is for adults aged 18-75 with prurigo nodularis, experiencing severe itchiness. Participants must have had the condition for at least 3 months, with a minimum of 20 itchy skin lesions across two body regions. They should have tried other treatments without success or cannot use them due to intolerance or contraindications.

Inclusion Criteria

I am between 18 and 75 years old.

I have had severe itching, scoring 7 or more, in the past week.

I have been diagnosed with peripheral neuropathy for at least 3 months.

Exclusion Criteria

My nerve pain is caused by medication.

I have tried JAK or TYK2 inhibitors for PN or inflammation without success.

Evidence of infection with TB, HBV, HCV or HIV

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive povorcitinib or placebo to evaluate its effect on itch and skin lesions

24 weeks

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 weeks

Treatment Details

Interventions

• Povorcitinib (Tyrosine Kinase Inhibitor)

Trial Overview The study tests povorcitinib's effectiveness on reducing itch and healing skin lesions in prurigo nodularis patients compared to a placebo. Povorcitinib is an experimental medication given to see if it can provide relief where other treatments haven't worked.

Participant Groups

Group I: Povorcitinib Dose 2 Experimental Treatment 1 Intervention

Povorcitinib at the protocol-defined dose.

Group II: Povorcitinib Dose 1 Experimental Treatment 1 Intervention

Povorcitinib at the protocol-defined dose.

Group III: Placebo Placebo Group 1 Intervention

Placebo at the protocol-defined dose.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Trueblue Clinical Research Moore Clinical Research, Inc McR Tampa Clinic Location Brandon, FL

Dermatology Associates Pc Rockville, MD

Michigan Dermatology Institute Waterford, MI

Central Sooner Research Oklahoma City, OK

More Trial Locations

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Patients Recruited

66,800+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nemolizumab efficacy in prurigo nodularis: onset of action on itch and sleep disturbances. Ständer, S., Yosipovitch, G., Lacour, JP., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Prurigo Including Prurigo Nodularis: New Insights and Treatments. Müller, S., Zeidler, C., Ständer, S.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Worst itch numerical rating scale for prurigo nodularis: a psychometric evaluation. Ständer, S., Zeidler, C., Pereira, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of evidence-based treatments for prurigo nodularis. Qureshi, AA., Abate, LE., Yosipovitch, G., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis. Ständer, S., Yosipovitch, G., Legat, FJ., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Nemolizumab efficacy in prurigo nodularis: onset of action on itch and sleep disturbances. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Chronic Prurigo Including Prurigo Nodularis: New Insights and Treatments. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Worst itch numerical rating scale for prurigo nodularis: a psychometric evaluation. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A systematic review of evidence-based treatments for prurigo nodularis. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis. [2020]