Povorcitinib for Prurigo Nodularis
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Incyte Corporation
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.
Is the drug Povorcitinib a promising treatment for prurigo nodularis?The information provided does not mention Povorcitinib directly, so we can't say if it's promising. However, other drugs like Dupilumab and Nemolizumab are showing promise in treating prurigo nodularis, which is a skin condition with itchy bumps.2781011
What data supports the idea that the drug Povorcitinib for Prurigo Nodularis is an effective treatment?The available research does not provide specific data on Povorcitinib for Prurigo Nodularis. Instead, it highlights other treatments like Dupilumab, which has been shown to be effective in reducing symptoms of Prurigo Nodularis in several studies. Dupilumab has been approved for this condition and has demonstrated a good or excellent response in patients, with improvements in itchiness and skin lesions. More research is needed to evaluate Povorcitinib's effectiveness for Prurigo Nodularis.1241011
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if your prurigo nodularis is secondary to medications, you may be excluded from the trial.
What safety data exists for Povorcitinib in treating prurigo nodularis?The research provided does not contain specific safety data for Povorcitinib (also known as INCB-054707 or INCB-54707) in the treatment of prurigo nodularis. However, it is mentioned as a small molecule under investigation in clinical trials for this condition. Further details on its safety profile would likely be found in the results of these specific clinical trials.13569
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 have had severe itching, scoring 7 or more, in the past week.
I have 20 or more itchy spots on at least 2 different parts of my body.
Exclusion Criteria
My nerve pain is caused by medication.
I have had active atopic dermatitis symptoms, not just dry skin, in the last 3 months.
I have tried JAK or TYK2 inhibitors for PN or inflammation without success.
I am currently pregnant, considering pregnancy, or breastfeeding.
I have long-term itching not caused by nerve or psychological conditions.
I have a history of blood, heart, infection, or cancer-related health issues.
Treatment Details
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.
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
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Who is running the clinical trial?
Incyte CorporationLead Sponsor
References
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.
Dupilumab for prurigo nodularis: Case series and review of the literature. [2021]Dupilumab is a recombinant complete human monoclonal antibody modulating the signaling of interleukin-4 and interleukin-13 pathways and has been approved for the treatment of moderate/severe atopic dermatitis. Here, we present three cases of prurigo nodularis treated off-label with dupilumab, and a review of the existing literature. All patients in this study had longstanding severe disease and had tried multiple treatment modalities. They were treated with dupilumab at an initial dose of 600 mg subcutaneously, followed by 300 mg every 2 weeks. Systematic literature searches were performed to identify literature describing the evaluation of the effect of treatment with dupilumab in prurigo nodularis. The physician's assessment of the patients revealed a good or excellent response to the treatment with dupilumab. Patients were evaluated after treatment for 4 and 7 months. Treatment was generally well-tolerated; one in three patients reported dry eyes. Four studies with a total of 11 patients (range: 1-4) were identified by the literature search. Complete response was noted in all 11 patients. Treatment with dupilumab appears to be safe and well-tolerated with clinical benefit in recalcitrant prurigo nodularis. Larger randomized and controlled trials using validated outcome measures are needed before dupilumab could be applied in clinical settings.
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.
Dupilumab in prurigo nodularis: a systematic review of current evidence and analysis of predictive factors to response. [2022]Dupilumab has been shown effective for prurigo nodularis (PN). However, precise data about efficacy of dupilumab as off-label use in PN is missing. We aggregated current evidence to assess efficacy of dupilumab in PN and to identify possible response predictors.
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).
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.
New Dupilumab Indication for Rare Skin Disease. [2023]Dupilumab (Dupixent) has been approved for the treatment of prurigo nodularis, a rare skin disease.Nurses should teach patients how to administer the drug subcutaneously using the prefilled syringe and how to discard the used syringe.
Modulation of Neuroimmune and Epithelial Dysregulation in Patients With Moderate to Severe Prurigo Nodularis Treated With Nemolizumab. [2023]Prurigo nodularis (PN) is a debilitating skin disease characterized by intense pruritus and hyperkeratotic skin nodules. Nemolizumab, a monoclonal antibody targeting interleukin 31 receptor α, is a promising novel therapy for the treatment of moderate to severe PN. The biological mechanisms by which nemolizumab promotes improvement of itch and skin lesions in PN are unknown.
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.
Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. [2023]Prurigo nodularis is a chronic, debilitating, and severely pruritic neuroimmunologic skin disease. Nemolizumab, an interleukin-31 receptor alpha antagonist, down-regulates key pathways in the pathogenesis of prurigo nodularis.
Dupilumab for the Treatment of Prurigo Nodularis. [2023]Prurigo nodularis (PN) is a chronic inflammatory skin condition characterized by the presence of pruritic nodules. Dupilumab was approved by the US Food and Drug Administration in September 2022 and Health Canada in July 2023 for the treatment of PN. Dupilumab is a human monoclonal immunoglobulin G4 antibody that binds the interleukin (IL)-4 receptor alpha subunit, blocking intercellular signalling of IL-4 and IL-13. Inhibition of these cytokines downregulates the inflammatory response and improves disease severity and pruritus. Two randomized controlled trials have shown dupilumab to be effective in reducing pruritus and lesion count in patients with PN. The approval of dupilumab for PN represents the first approved therapy for PN and may indicate a paradigm shift in the way this condition is treated.