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.12345
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.
See 3 more
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
See 5 more
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 OverviewThe 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
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Povorcitinib Dose 2Experimental Treatment1 Intervention
Povorcitinib at the protocol-defined dose.
Group II: Povorcitinib Dose 1Experimental Treatment1 Intervention
Povorcitinib at the protocol-defined dose.
Group III: PlaceboPlacebo Group1 Intervention
Placebo at the protocol-defined dose.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Trueblue Clinical Research Moore Clinical Research, Inc McR Tampa Clinic LocationBrandon, FL
Dermatology Associates PcRockville, MD
Michigan Dermatology InstituteWaterford, MI
Central Sooner ResearchOklahoma City, OK
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Incyte CorporationLead Sponsor
References
Nemolizumab efficacy in prurigo nodularis: onset of action on itch and sleep disturbances. [2022]Patients with prurigo nodularis (PN) have multiple itchy nodules, impaired quality of life and sleep deprivation. Prurigo nodularis patients have a high burden of disease, primarily due to the intensity of the itch. It is reasonable to expect that rapid relief of itch - and associated improvement of sleep - are highly valued clinical outcomes for patients. Nemolizumab is an IL-31A-receptor inhibitor that modulates the neuroimmune response with reported positive efficacy and safety data in a phase 2 study of PN.
Chronic Prurigo Including Prurigo Nodularis: New Insights and Treatments. [2023]Chronic prurigo (CPG) is a neuroinflammatory, fibrotic dermatosis that is defined by the presence of chronic pruritus (itch lasting longer than 6 weeks), scratch-associated pruriginous skin lesions and history of repeated scratching. Patients with CPG experience a significant psychological burden and a notable impairment in their quality of life. Chronic prurigo of nodular type (CNPG; synonym: prurigo nodularis) represents the most common subtype of CPG. As CNPG is representative for all CPG subtypes, we refer in this review to both CNPG and CPG. We provide an overview of the clinical characteristics and assessment of CPG, the burden of disease and the underlying pathophysiology including associated therapeutic targets. The information provided results from a PubMed search for the latest publications and a database search for current clinical trials (ClinicalTrials.gov, EU Clinical Trials Register [European Medicines Agency]; using the following terms or combinations of terms: 'chronic prurigo', 'prurigo', 'prurigo nodularis', 'pathophysiology', 'therapy', 'biologics', 'treatment'). Dupilumab is the first authorized systemic therapy by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for CNPG to date. Topical and systemic agents that are currently under investigation in clinical randomized, placebo-controlled phase II and III trials such as biologics (e.g., nemolizumab, vixarelimab/KPL-716, barzolvolimab/CDX-0159), small molecules (ruxolitinib cream, povorcitinib/INCB054707, abrocitinib) and the opioid modulator nalbuphine are highlighted. In the last past 15 years, several milestones have been reached regarding the disease understanding of CPG such as first transcriptomic analysis, first terminology, first guideline, and first therapy approval in 2022, which contributed to improved medical care of affected patients. The broad range of identified targets, current case observations and initiated trials offers the possibility of more drug approvals in the near future.
Worst itch numerical rating scale for prurigo nodularis: a psychometric evaluation. [2022]Study TR03 evaluated the safety and efficacy of nalbuphine ER for prurigo nodularis (PN; NCT02174419).
A systematic review of evidence-based treatments for prurigo nodularis. [2019]Prurigo nodularis is a chronic dermatologic condition involving the development of multiple cutaneous nodules in the setting of intractable pruritus. Given emerging treatment options for this difficult-to-treat condition, a current review of therapeutics is needed. A systematic review was performed for clinical studies investigating prurigo nodularis treatment published from 1990 to present including ≥5 subjects. A total of 35 articles were assigned a level of evidence according to the Oxford Center for Evidence-based Medicine. All 5 studies investigating topical agents, including corticosteroids, calcineurin inhibitors, calcipotriol, and capsaicin, conveyed some beneficial effect with level of evidence 2b or higher. Six of 8 reports investigating photo- and photochemotherapy achieved levels of evidence 2b or greater and showed good partial response rates. Thalidomide was studied by 6 reports providing evidence of good symptom response, only 2 of which were rated level 2b or greater. Cyclosporine and methotrexate have demonstrated benefit in 4 combined studies, albeit with level 4 evidence. Pregabalin, amitriptyline, paroxetine, fluvoxamine, and neurokinin-1 receptor antagonists have demonstrated promising evidence in 5 level 2b studies. Higher-powered studies and additional randomized controlled trials are needed for the evaluation of safe and efficacious systemic treatment options for prurigo nodularis.
Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis. [2020]Prurigo nodularis is a chronic pruritic skin disease with multiple nodular skin lesions. Nemolizumab is a monoclonal antibody targeting the interleukin-31 receptor, which is involved in the pathogenesis of prurigo nodularis.