Clinical Trials in Italy / NCT06516952
Active, not recruiting
Phase 3
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)
NCT06516952 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Prurigo Nodularis
Investigational drug(s) / intervention(s)
Povorcitinib →Placebo
Povorcitinib: Oral Tablet
Placebo: Oral Tablet
Study summary
The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.
Eligibility
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.
Primary outcome measure(s)
- Proportion of participants achieving Itch NRS4 and IGA-CPG-S-TS at Week 24 — Week 24
Defined as proportion of participants achieving a ≥ 4-point improvement \[reduction\] in Itch NRS score from baseline (Itch NRS4) and an IGA CPG-S score of 0 or 1 with a ≥ 2-grade improvement from baseline (IGA-CPG-S-TS).
Trial sites (120)
| Facility | City | Region | Status |
|---|---|---|---|
| Cahaba Dermatology | Birmingham | Alabama | |
| Banner - University Medicine Multispecialty Services Clinic | Tucson | Arizona | |
| Premier Dermatology Clinical Trials Institute At Northwest Arkansas | Fayetteville | Arkansas | |
| Burke Pharmaceutical Research | Hot Springs | Arkansas | |
| Dermatology Research Associates | Los Angeles | California | |
| Northridge | Northridge | California | |
| Rendon Center the Dermatology and Aesthetic Center | Boca Raton | Florida | |
| Driven Research Llc | Coral Gables | Florida | |
| University of Miami Miller School of Medicine | Miami | Florida | |
| Research Institute of the Southeast, Llc | West Palm Beach | Florida | |
| Illinois Dermatology Institute the Chicago Loop | Chicago | Illinois | |
| Chicago Cosmetic Surgery and Dermatology | Chicago | Illinois | |
| Center For Medical Dermatology and Immunology Research | Chicago | Illinois | |
| Northshore University Healthsystem | Skokie | Illinois | |
| Dermatology Specialists Research Indiana | Clarksville | Indiana | |
| Oakland Hills Dermatology | Auburn Hills | Michigan | |
| Hamzavi Dermatology | Fort Gratiot | Michigan | |
| Somerset Skin Centre | Troy | Michigan | |
| Medisearch Clinical Trials | Saint Joseph | Missouri | |
| Washington University School of Medicine | St Louis | Missouri | |
| The University of New Mexico Unm Health Sciences Center Hsc | Albuquerque | New Mexico | |
| Montefiore Medical Center | East Syracuse | New York | |
| Skin Center Dermatology Group | New York | New York | |
| Stony Brook Dermatology Associates | Stony Brook | New York | |
| Centricity Research Columbus | Columbus | Ohio | |
| Wright State Physicians Health Center | Dayton | Ohio | |
| International Clinical Research Tennessee Llc | Murfreesboro | Tennessee | |
| Dermatology Treatment and Research Center | Dallas | Texas | |
| Sweetwater Dermatology | Sugar Land | Texas | |
| Center For Clinical Studies | Webster | Texas | |
| Frontier Dermatology | Mill Creek | Washington | |
| Conexa Investigacion Clinica S.A. | Buenos Aires | Argentina | |
| Cedic - Centro de Investigacion Clinica | Buenos Aires | Argentina | |
| Instituto de Neumonologia Y Dermatologia | Buenos Aires | Argentina | |
| Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias (Inaer) | Buenos Aires | Argentina | |
| Centro de Investigaciones Medicas Mar Del Plata | Mar del Plata | Argentina | |
| Instituto Especialidades de La Salud Rosario - Clinica Del Torax | Rosario | Argentina | |
| Investigaciones Reumatologicas Tucuman S.R.L. | San Miguel de Tucumán | Argentina | |
| Medical University Graz University Clinic For Dermatology and Venerology | Graz | Austria | |
| Wiener Krankenanstaltenverbund (Kav) - Krankenhaus Hietzing Mit Neurologischem Zentrum Rosenhuegel | Vienna | Austria |
+ 80 more sites — see the full list on the official registry below.
More Incyte Corporation trials in Italy
Other trials for the same condition
A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06516952 on ClinicalTrials.gov ↗ ← All trials in Italy