Povorcitinib for Prurigo Nodularis

(STOP-PN1 Trial)

Recruiting at 210 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called povorcitinib to determine if it can reduce itching and skin bumps in people with prurigo nodularis, a condition causing severe itching and hard, itchy lumps on the skin. Researchers will compare two different doses of povorcitinib against a placebo (a harmless pill with no active medicine) to identify which dose works best. Suitable candidates for the trial have had prurigo nodularis for at least three months, experience intense itching, and have tried other treatments without success. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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 there any evidence suggesting that povorcitinib is likely to be safe for humans?

Research shows that povorcitinib is generally safe for people, with studies finding no major safety concerns. For example, past participants mostly experienced mild to moderate side effects like headaches or nausea, which are common and manageable.

Additional research on povorcitinib for conditions such as hidradenitis suppurativa also confirmed its safety. No unexpected safety issues arose, and its effects were similar to a placebo, a harmless treatment used for comparison.

Overall, these findings suggest that povorcitinib is safe for those considering joining a trial for prurigo nodularis. However, as with any treatment, monitoring for side effects remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about povorcitinib for prurigo nodularis because it represents a novel approach to managing this chronic skin condition. Unlike many current treatments that primarily focus on reducing symptoms through topical steroids or immunosuppressants, povorcitinib targets specific pathways in the immune system, potentially offering more precise and effective relief. This new mechanism of action could lead to improved outcomes for patients who have not found success with existing therapies. Additionally, the convenience of an oral medication like povorcitinib may enhance patient adherence compared to some existing treatment options that require topical application.

What evidence suggests that povorcitinib might be an effective treatment for prurigo nodularis?

Research has shown that povorcitinib reduces itching and improves skin problems in people with prurigo nodularis. In earlier studies, patients who took povorcitinib experienced significant relief from itchiness and improved skin condition after just 16 weeks. This trial will test different doses of povorcitinib, and previous research has demonstrated clear benefits at various doses. Additionally, povorcitinib has proven effective in treating similar skin conditions, such as hidradenitis suppurativa, which adds to its credibility. Overall, the evidence strongly supports povorcitinib's effectiveness for prurigo nodularis. ^{1 2 5 6 7}

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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]

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]

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]

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]

Citations

1. incytemi.com incytemi.com/document/Poster/EADV%202024_Kwatra_40-Wk%20Results%20From%20Phase%202%20Povo%20in%20PN%20Study.pdf

Efficacy and Safety of Oral Povorcitinib in Patients With ... Patients not meeting the definition of a responder were considered as nonresponders. ‡ Data for study visits calculated as the average of the ...

2. investor.incyte.com investor.incyte.com/news-releases/news-release-details/incyte-presents-new-late-breaking-data-phase-2-study-evaluating

Incyte Presents New Late-Breaking Data from Phase 2 ... Randomized Phase 2 study met its primary and secondary endpoints following 16 weeks of treatment across all dosing groups, ...

3. dermatologytimes.com dermatologytimes.com/view/late-breaking-data-povorcitinib-significantly-improves-itch-and-lesions-in-prurigo-nodularis

Late-Breaking Data: Povorcitinib Significantly Improves Itch ... The study authors concluded that “povorcitinib demonstrated a clinical impact on itch and prurigo nodularis lesions, was generally well ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06516965

NCT06516965 | A Study to Evaluate the Efficacy and ... The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.

5. healio.com healio.com/news/dermatology/20250317/new-data-support-efficacy-safety-of-povorcitinib-for-hidradenitis-suppurativa

New data support efficacy, safety of povorcitinib for ... Newly released data from the phase 3 STOP-HS clinical trial program reveal positive results in hidradenitis suppurativa from povorcitinib treatment.

6. investor.incyte.com investor.incyte.com/news-releases/news-release-details/incyte-announces-new-24-week-phase-3-data-stop-hs-clinical-trial

Incyte Announces New 24-Week Phase 3 Data from the ... A significantly higher proportion of patients treated with povorcitinib once daily (QD) versus placebo achieved Hidradenitis Suppurativa ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06516952

NCT06516952 | A Study to Evaluate the Efficacy and ... The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.