Clinical Trials in Japan / NCT06516965
Active, not recruiting
Phase 3
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)
NCT06516965 · tracked via the Priya Life Science Japan 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 (119)
| Facility | City | Region | Status |
|---|---|---|---|
| Medical Dermatology Specialists Phoenix | Phoenix | Arizona | |
| Investigate Md | Scottsdale | Arizona | |
| First Oc Dermatology Research Inc | Fountain Valley | California | |
| Clinical Science Institute Clinical Research Specialists Inc | Santa Monica | California | |
| Center For Clinical and Cosmetic Research | Aventura | Florida | |
| Schweiger Dermatology | Boca Raton | Florida | |
| Direct Helpers Research Center | Hialeah | Florida | |
| Skin Care Research, Llc | Hollywood | Florida | |
| Ziaderm Research, Llc | Miami | Florida | |
| Nodal Medical Center, Llc | Tampa | Florida | |
| Trueblue Clinical Research Moore Clinical Research, Inc McR Tampa Clinic Location | Tampa | Florida | |
| Dermatology Specialists Research | Louisville | Kentucky | |
| University of Maryland School of Medicine | Baltimore | Maryland | |
| Dermatology Associates Pc | Rockville | Maryland | |
| Metro Boston Clinical Partners | Brighton | Massachusetts | |
| Fivenson Dermatology | Ann Arbor | Michigan | |
| Henry Ford Health System | Detroit | Michigan | |
| Michigan Dermatology Institute | Waterford | Michigan | |
| Allcutis Research, Llc | Portsmouth | New Hampshire | |
| Schweiger Dermatology | Hackensack | New Jersey | |
| OPTISKIN | New York | New York | |
| University of Cincinnati Cancer Institute | Cincinnati | Ohio | |
| Central Sooner Research | Oklahoma City | Oklahoma | |
| Paddington Testing Co Inc | Philadelphia | Pennsylvania | |
| Yardley Dermatology Associates | Yardley | Pennsylvania | |
| Modern Research Associates Pllc | Dallas | Texas | |
| University of Utah Midvalley Dermatology | Murray | Utah | |
| Aesthetic General Dermatology of Seattle | Burien | Washington | |
| Novatrials | Charlestown | New South Wales | |
| Premier Specialists Pty Ltd | Kogarah | New South Wales | |
| Skin & Cancer Foundation Australia | Sydney | New South Wales | |
| Westmead Hospital | Westmead | New South Wales | |
| Veracity Clinical Research Pty Ltd | Woolloongabba | Queensland | |
| The Alfred Hospital | Melbourne | Victoria | |
| Fremantle Dermatology | Fremantle | Australia | |
| Az Sint-Jan Brugge Av | Bruges | Belgium | |
| Universitair Ziekenhuis Gent (Uz Gent) | Ghent | Belgium | |
| Grand Hopital de Charleroi - Site Imtr | Gilly | Belgium | |
| Centre Hospitalier Universitaire (Chu) de Liege - Domaine Universitaire Du Sart Tilman | Liège | Belgium | |
| Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc | Woluwe-Saint-Lambert | Belgium |
+ 79 more sites — see the full list on the official registry below.
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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 NCT06516965 on ClinicalTrials.gov ↗ ← All trials in Japan