RECRUITING

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis

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Conditions

Prurigo NodularisPNINCB054707chronic pruritus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-10-10
Study Completion:2027-06-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06516952

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female participants 18 to 75 years of age.
  2. * Clinical diagnosis of PN for at least 3 months prior to Screening visit.
  3. * Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day 1/Baseline.
  4. * 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.
  5. * Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment.
  6. * Willingness to avoid pregnancy or fathering children.
  1. * Chronic pruritus due to a condition other than PN or neuropathic and psychogenic pruritus.
  2. * Diagnosis of PN secondary to medications.
  3. * Active AD lesions (signs and symptoms other than dry skin) within 3 months prior to Screening visit.
  4. * Women who are pregnant (or are considering pregnancy) or breastfeeding.
  5. * 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.
  6. * Evidence of infection with TB, HBV, HCV or HIV.
  7. * History of failure to any topical or systemic JAK or TYK2 inhibitor as treatment of PN or any inflammatory disease.
  8. * Laboratory values outside of the protocol-defined ranges.

Contacts and Locations

Study Contact

Incyte Corporation Call Center (US)
CONTACT
1.855.463.3463
medinfo@incyte.com
Incyte Corporation Call Center (ex-US)
CONTACT
+800 00027423
eumedinfo@incyte.com

Principal Investigator

Incyte Medical Monitor
STUDY_DIRECTOR
Incyte Corporation

Study Locations (Sites)

Cahaba Dermatology
Birmingham, Alabama, 35244
United States
Banner - University Medicine Multispecialty Services Clinic
Tucson, Arizona, 85718
United States
Premier Dermatology Clinical Trials Institute At Northwest Arkansas
Fayetteville, Arkansas, 72703
United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
United States
Dermatology Research Associates
Los Angeles, California, 90045
United States
Northridge
Northridge, California, 91325
United States
Rendon Center the Dermatology and Aesthetic Center
Boca Raton, Florida, 33486
United States
Driven Research Llc
Coral Gables, Florida, 33134
United States
University of Miami Miller School of Medicine
Miami, Florida, 33125
United States
Alliance Clinical Research Tampa
Tampa, Florida, 33615
United States
Research Institute of the Southeast, Llc
West Palm Beach, Florida, 33401
United States
Illinois Dermatology Institute the Chicago Loop
Chicago, Illinois, 60602
United States
Chicago Cosmetic Surgery and Dermatology
Chicago, Illinois, 60654
United States
Center For Medical Dermatology and Immunology Research
Chicago, Illinois, 60657
United States
Northshore University Healthsystem
Skokie, Illinois, 60077
United States
Dermatology Specialists Research Ds Research Indiana Location
Clarksville, Indiana, 47129
United States
Velocity Clinical Research At the Dermatology Clinic
Baton Rouge, Louisiana, 70808
United States
Oakland Hills Dermatology
Auburn Hills, Michigan, 48326
United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
United States
Somerset Skin Centre
Troy, Michigan, 48084
United States
Medisearch Clinical Trials
Saint Joseph, Missouri, 64506
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
The University of New Mexico Unm Health Sciences Center Hsc
Albuquerque, New Mexico, 87131
United States
Montefiore Medical Center
East Syracuse, New York, 13057
United States
Skin Center Dermatology Group
New York, New York, 10956
United States
Stony Brook Dermatology Associates
Stony Brook, New York, 11790
United States
Wright State Physicians Health Center
Dayton, Ohio, 45324
United States
Centricity Research Aventiv Research Dublin
Dublin, Ohio, 43016
United States
Dermdox Dermatology Centers, Pc
Camp Hill, Pennsylvania, 17011
United States
University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building
Pittsburgh, Pennsylvania, 15213
United States
Palmetto Clinical Trial Services
Anderson, South Carolina, 29621
United States
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee, 37130
United States
Dermatology Treatment and Research Center
Dallas, Texas, 75230
United States
Center For Clinical Studies
Houston, Texas, 77004
United States
Sweetwater Dermatology
Sugar Land, Texas, 77479
United States
Frontier Dermatology
Mill Creek, Washington, 98012
United States

Collaborators and Investigators

Sponsor: Incyte Corporation

  • Incyte Medical Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-10
Study Completion Date2027-06-02

Study Record Updates

Study Start Date2024-10-10
Study Completion Date2027-06-02

Terms related to this study

Keywords Provided by Researchers

  • Prurigo nodularis
  • PN
  • INCB054707
  • chronic pruritus

Additional Relevant MeSH Terms

  • Prurigo Nodularis