A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)

Description

The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.

Conditions

Prurigo Nodularis

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Study Overview

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Study Details

Study overview

The purpose of this study is to evaluate effect of povorcitinib on itch and skin lesions in participants with prurigo nodularis.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)

Condition
Prurigo Nodularis
Intervention / Treatment

-

Contacts and Locations

Phoenix

Medical Dermatology Specialists Phoenix, Phoenix, Arizona, United States, 85006

Scottsdale

Investigate Md, Scottsdale, Arizona, United States, 85255

Fayetteville

Premier Dermatology Clinical Trials Institute At Northwest Arkansas, Fayetteville, Arkansas, United States, 72703

Fountain Valley

First Oc Dermatology Research Inc, Fountain Valley, California, United States, 92708-3701

Los Angeles

Dermatology Research Associates, Los Angeles, California, United States, 90045

Sacramento

Integrative Skin Science and Research, Sacramento, California, United States, 95815

Santa Monica

Clinical Science Institute Clinical Research Specialists Inc, Santa Monica, California, United States, 90404

Aventura

Center For Clinical and Cosmetic Research, Aventura, Florida, United States, 33180

Boca Raton

Clearlyderm Dermatology, Boca Raton, Florida, United States, 33428

Brandon

Trueblue Clinical Research Moore Clinical Research, Inc McR Tampa Clinic Location, Brandon, Florida, United States, 33511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Incyte Corporation,

Incyte Medical Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

2027-06-02