Povorcitinib for Prurigo Nodularis

(STOP-PN1 Trial)

Recruiting at 148 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Incyte Corporation

Must not be taking: JAK inhibitors, TYK2 inhibitors

Disqualifiers: Chronic pruritus, Cardiovascular diseases, Infections, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

330 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if your prurigo nodularis is caused by medications, you may not be eligible to participate.

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, a skin condition causing itchy bumps. Participants must have had the condition and related itching for at least 3 months, with at least 20 lesions across two body areas. They should have tried other treatments without success or cannot use them due to intolerance or contraindications.

Inclusion Criteria

I have had severe itching for the past week.

I have 20 or more itchy spots on at least 2 different parts of my body.

I've had a bad reaction or no improvement from past peripheral neuropathy treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive povorcitinib or placebo for the evaluation of efficacy and safety in prurigo nodularis

24 weeks

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 weeks

Treatment Details

Interventions

• Povorcitinib

Trial Overview The study tests Povorcitinib's effectiveness on reducing itchiness and skin lesions in Prurigo Nodularis patients compared to a placebo (a substance with no active drug). It aims to determine if Povorcitinib can improve symptoms better than an inactive treatment.

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.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

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

Findings from Research

In a 12-week phase 2 trial involving 70 patients with moderate-to-severe prurigo nodularis, nemolizumab significantly reduced pruritus by 53% compared to a 20% reduction in the placebo group, demonstrating its efficacy in alleviating severe itching.

While nemolizumab showed promising results in reducing symptoms, it was associated with gastrointestinal and musculoskeletal side effects, indicating the need for further studies to assess its long-term safety and effectiveness.

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]

Chronic prurigo (CPG), particularly its most common subtype, chronic prurigo of nodular type (CNPG), significantly impacts patients' quality of life due to persistent itching and skin lesions, highlighting the need for effective treatments.

Dupilumab is the first systemic therapy approved for CNPG by both the EMA and FDA, and ongoing clinical trials are exploring various new treatments, including biologics and small molecules, which may lead to more options for patients in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a phase 2 trial involving 70 patients with moderate-to-severe prurigo nodularis, nemolizumab significantly reduced itch within 48 hours compared to placebo, demonstrating a 19.5% reduction in peak pruritus.

Patients treated with nemolizumab also experienced significant improvements in sleep disturbances by Day 4, with a 24.0% reduction in sleep disturbance scores, indicating its potential to enhance quality of life for those suffering from this condition.

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]

In a phase 2 trial involving 62 patients with prurigo nodularis, nalbuphine ER significantly reduced itch severity, as measured by the Worst Itch Numeric Rating Scale (WI-NRS), with scores improving from an average of 8.2 at baseline to 5.8 by week 10.

The WI-NRS showed strong reliability and validity, making it a useful tool for assessing treatment effects in prurigo nodularis, with a responder threshold indicating a meaningful improvement of at least 3.8 points.

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]

Topical treatments for prurigo nodularis, including corticosteroids and calcineurin inhibitors, have shown beneficial effects in clinical studies, with a level of evidence of 2b or higher across all five studies reviewed.

Phototherapy and systemic treatments like thalidomide, pregabalin, and amitriptyline also demonstrated effectiveness, but more high-quality studies and randomized controlled trials are needed to confirm their safety and efficacy.

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]

References

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

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

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

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

4. England pubmed.ncbi.nlm.nih.gov

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

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

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