Evaluating the effects of povorcitinib on prurigo nodularis
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis
This study is testing if a new medication called povorcitinib can help people with prurigo nodularis feel less itchy and improve their skin lesions.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Incyte Corporation Industry-sponsored |
| Drugs / interventions | povorcitinib |
| Locations | 120 sites (Birmingham, Alabama and 119 other locations) |
| Trial ID | NCT06516952 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy and safety of povorcitinib in treating participants with prurigo nodularis, a condition characterized by intense itching and skin lesions. Participants will receive either the active drug or a placebo to determine the impact on their symptoms. The study will include individuals aged 18 to 75 who have experienced prurigo nodularis for at least three months and have a significant itch score. The primary focus is on reducing itch and improving skin lesions associated with this chronic condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a clinical diagnosis of prurigo nodularis and a high level of itch.
Not a fit: Patients with chronic pruritus from conditions other than prurigo nodularis or those with secondary prurigo nodularis due to medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate the debilitating itch and skin lesions experienced by patients with prurigo nodularis.
How similar studies have performed: Other studies have shown promise in treating prurigo nodularis with similar approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female participants 18 to 75 years of age. * Clinical diagnosis of PN for at least 3 months prior to Screening visit. * Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day 1/Baseline. * Total of ≥ 20 pruriginous lesions on ≥ 2 different body regions (both legs, and/or both arms, and/or trunk) at Screening and Day 1/Baseline. * Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * Chronic pruritus due to a condition other than PN or neuropathic and psychogenic pruritus. * Diagnosis of PN secondary to medications. * Active AD lesions (signs and symptoms other than dry skin) within 3 months prior to Screening visit. * Women who are pregnant (or are considering pregnancy) or breastfeeding. * Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies. * Evidence of infection with TB, HBV, HCV or HIV. * History of failure to any topical or systemic JAK or TYK2 inhibitor as treatment of PN or any inflammatory disease. * Laboratory values outside of the protocol-defined ranges. Other protocol-defined Inclusion/Exclusion Criteria apply.
Where this trial is running
Birmingham, Alabama and 119 other locations
- Cahaba Dermatology — Birmingham, Alabama, United States (Recruiting)
- Banner - University Medicine Multispecialty Services Clinic — Tucson, Arizona, United States (Recruiting)
- Premier Dermatology Clinical Trials Institute At Northwest Arkansas — Fayetteville, Arkansas, United States (Completed)
- Burke Pharmaceutical Research — Hot Springs, Arkansas, United States (Recruiting)
- Dermatology Research Associates — Los Angeles, California, United States (Recruiting)
- Northridge — Northridge, California, United States (Recruiting)
- Rendon Center the Dermatology and Aesthetic Center — Boca Raton, Florida, United States (Recruiting)
- Driven Research Llc — Coral Gables, Florida, United States (Recruiting)
- University of Miami Miller School of Medicine — Miami, Florida, United States (Recruiting)
- Research Institute of the Southeast, Llc — West Palm Beach, Florida, United States (Recruiting)
- Illinois Dermatology Institute the Chicago Loop — Chicago, Illinois, United States (Recruiting)
- Chicago Cosmetic Surgery and Dermatology — Chicago, Illinois, United States (Completed)
- Center For Medical Dermatology and Immunology Research — Chicago, Illinois, United States (Recruiting)
- Northshore University Healthsystem — Skokie, Illinois, United States (Completed)
- Dermatology Specialists Research Indiana — Clarksville, Indiana, United States (Recruiting)
- Oakland Hills Dermatology — Auburn Hills, Michigan, United States (Recruiting)
- Hamzavi Dermatology — Fort Gratiot, Michigan, United States (Completed)
- Somerset Skin Centre — Troy, Michigan, United States (Completed)
- Medisearch Clinical Trials — Saint Joseph, Missouri, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
- The University of New Mexico Unm Health Sciences Center Hsc — Albuquerque, New Mexico, United States (Recruiting)
- Montefiore Medical Center — East Syracuse, New York, United States (Completed)
- Skin Center Dermatology Group — New York, New York, United States (Recruiting)
- Stony Brook Dermatology Associates — Stony Brook, New York, United States (Recruiting)
- Centricity Research Columbus — Columbus, Ohio, United States (Recruiting)
- Wright State Physicians Health Center — Dayton, Ohio, United States (Recruiting)
- International Clinical Research Tennessee Llc — Murfreesboro, Tennessee, United States (Completed)
- Dermatology Treatment and Research Center — Dallas, Texas, United States (Recruiting)
- Sweetwater Dermatology — Sugar Land, Texas, United States (Completed)
- Center For Clinical Studies — Webster, Texas, United States (Recruiting)
- Frontier Dermatology — Mill Creek, Washington, United States (Recruiting)
- Conexa Investigacion Clinica S.A. — Buenos Aires, Argentina (Recruiting)
- Cedic - Centro de Investigacion Clinica — Buenos Aires, Argentina (Recruiting)
- Instituto de Neumonologia Y Dermatologia — Buenos Aires, Argentina (Not_yet_recruiting)
- Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias (Inaer) — Buenos Aires, Argentina (Recruiting)
- Centro de Investigaciones Medicas Mar Del Plata — Mar del Plata, Argentina (Recruiting)
- Instituto Especialidades de La Salud Rosario - Clinica Del Torax — Rosario, Argentina (Recruiting)
- Investigaciones Reumatologicas Tucuman S.R.L. — San Miguel de Tucumán, Argentina (Recruiting)
- Medical University Graz University Clinic For Dermatology and Venerology — Graz, Austria (Recruiting)
- Wiener Krankenanstaltenverbund, Krankenhaus Hietzing Mit Neurologischem Zentrum Rosenhugel — Vienna, Austria (Recruiting)
- Medical Center Medconsult Pleven — Lovech, Bulgaria (Recruiting)
- Medconsult Pleven — Pleven, Bulgaria (Recruiting)
- Diagnostic-Consultative Centre Pulmed Eood — Plovdiv, Bulgaria (Recruiting)
- Medical Center Prolet Eood — Rousse, Bulgaria (Recruiting)
- Medical Center Unimed Eood — Sevlievo, Bulgaria (Recruiting)
- Diagnostic-Consultative Center Ascendent Eood — Sofia, Bulgaria (Recruiting)
- Diagnostic-Consultative Center Aleksandrovska Eood — Sofia, Bulgaria (Recruiting)
- Dermatology Research Institute — Calgary, Alberta, Canada (Recruiting)
- Rao Dermatology — Edmonton, Alberta, Canada (Recruiting)
- Skin Physicians — Edmonton, Alberta, Canada (Recruiting)
+70 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Incyte Corporation Call Center (US)
- Email: medinfo@incyte.com
- Phone: 1.855.463.3463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.