RECRUITING

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

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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

NCT06516965

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)

Medical Dermatology Specialists Phoenix
Phoenix, Arizona, 85006
United States
Investigate Md
Scottsdale, Arizona, 85255
United States
Premier Dermatology Clinical Trials Institute At Northwest Arkansas
Fayetteville, Arkansas, 72703
United States
First Oc Dermatology Research Inc
Fountain Valley, California, 92708-3701
United States
Dermatology Research Associates
Los Angeles, California, 90045
United States
Integrative Skin Science and Research
Sacramento, California, 95815
United States
Clinical Science Institute Clinical Research Specialists Inc
Santa Monica, California, 90404
United States
Center For Clinical and Cosmetic Research
Aventura, Florida, 33180
United States
Clearlyderm Dermatology
Boca Raton, Florida, 33428
United States
Trueblue Clinical Research Moore Clinical Research, Inc McR Tampa Clinic Location
Brandon, Florida, 33511
United States
Driven Research Llc
Coral Gables, Florida, 33134
United States
Direct Helpers Research Center
Hialeah, Florida, 33012
United States
Boynton Beach Facility
Hollywood, Florida, 33024
United States
Skin Care Research, Llc Scr Hollywood
Hollywood, Florida, 33201
United States
University of Miami Miller School of Medicine
Miami, Florida, 33125
United States
Ziaderm Research, Llc
Miami, Florida, 33162
United States
Dh Tamarac Research Center Etna Medical Center Emc
Tamarac, Florida, 33321
United States
Nodal Medical Center, Llc
Tampa, Florida, 33607
United States
Chicago Cosmetic Surgery and Dermatology
Chicago, Illinois, 60654
United States
Dermatology Specialists Research Indiana
Clarksville, Indiana, 47129
United States
Southern Indiana Clinical Trials
New Albany, Indiana, 47150
United States
Dermatology Specialists Research
Louisville, Kentucky, 40241
United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201
United States
Dermatology Associates Pc
Rockville, Maryland, 20850
United States
Metro Boston Clinical Partners
Brighton, Massachusetts, 02135-3511
United States
Fivenson Dermatology
Ann Arbor, Michigan, 48103
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
United States
Michigan Dermatology Institute
Waterford, Michigan, 48328
United States
Medisearch Clinical Trials
Saint Joseph, Missouri, 64506
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Allcutis Research, Llc
Portsmouth, New Hampshire, 03801
United States
Schweiger Dermatology
Hackensack, New Jersey, 07601
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Suny Downstate Medical Center
Brooklyn, New York, 11203
United States
Equity Medical, Llc
New York, New York, 100233
United States
OPTISKIN
New York, New York, 10128
United States
Oakview Dermatology
Athens, Ohio, 45701
United States
University of Cincinnati Health Physicians
Cincinnati, Ohio, 45213
United States
Centricity Research Aventiv Research Dublin
Dublin, Ohio, 43016
United States
Central Sooner Research
Oklahoma City, Oklahoma, 73118
United States
Paddington Testing Co Inc
Philadelphia, Pennsylvania, 19103
United States
Yardley Dermatology Associates
Yardley, Pennsylvania, 19067
United States
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee, 37130
United States
Modern Research Associates Pllc
Dallas, Texas, 75231
United States
University of Utah Midvalley Dermatology
Murray, Utah, 84107
United States
Aesthetic General Dermatology of Seattle
Seattle, Washington, 98168
United States
West Virginia Research Institute
Morgantown, West Virginia, 26505
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