Povorcitinib for Prurigo Nodularis

Recruiting at 186 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: Pregnancy, 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 the effects of povorcitinib on itchiness and skin bumps in individuals with prurigo nodularis, a condition causing intense itching and hard nodules on the skin. Participants will receive one of two doses of povorcitinib, a new potential drug, or a placebo to compare results. Eligible participants must have had prurigo nodularis for at least three months, experience severe itching, and have at least 20 itchy lesions on their body. They should have tried other treatments without success or experienced side effects. 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.

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

Research shows that povorcitinib is generally safe for patients. Previous studies found no new safety issues with this medication. The Phase 2 trials achieved their main goals, demonstrating the treatment's effectiveness without unexpected problems. Other studies on similar conditions also support the safety of povorcitinib. While all medications can have side effects, current research suggests that povorcitinib is safe for people based on the available data. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about povorcitinib for treating prurigo nodularis because it targets the Janus kinase (JAK) pathway, which is a new approach compared to the conventional therapies like corticosteroids and antihistamines. Unlike these standard treatments, which often only manage symptoms temporarily, povorcitinib aims to address the underlying inflammatory processes contributing to the condition. This innovative mechanism has the potential to offer more sustained relief and possibly reduce the severity of the nodules, making it a promising option for patients who have not found success with existing therapies.

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

Research has shown that povorcitinib can help with prurigo nodularis, a skin condition that causes intense itching and bumps. In this trial, participants will receive either Povorcitinib Dose 1, Povorcitinib Dose 2, or a placebo. Studies have found that povorcitinib greatly reduces both itching and skin bumps in patients. Specifically, one study showed that patients experienced noticeable relief from itching and saw fewer bumps after 16 weeks of treatment. The medication has also been tested for other skin conditions with positive results, supporting its potential effectiveness. Overall, early findings suggest povorcitinib could provide significant relief for those with prurigo nodularis. ^{1 2 3 4 5}

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

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

I had a bad reaction or no improvement from my previous nerve pain treatment.

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

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 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

What Are the Treatments Tested in This Trial?

Interventions

• Povorcitinib

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.

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

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]

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 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]

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 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]

Citations

1. 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.

2. 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 ...

3. 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, ...

4. 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 ...

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.