A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
NCT ID: NCT05061693
Last Updated: 2025-07-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
146 participants
INTERVENTIONAL
2021-11-04
2024-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)
NCT06516952
A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis
NCT05052983
A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
NCT04501679
Study on the Treatment of Prurigo Nodularis With Stapokibart Injection
NCT06424470
A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN2)
NCT06516965
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
INCB054707 Dose A
Participants will receive INCB054707 Dose A for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
INCB054707
Oral; Tablet
INCB054707 Dose B
Participants will receive INCB054707 Dose B for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
INCB054707
Oral; Tablet
INCB054707 Dose C
Participants will receive INCB054707 Dose C for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
INCB054707
Oral; Tablet
Placebo followed by INCB054707 Dose B or C
Participants will receive placebo for 16 weeks (Period 1), followed by INCB054707 Dose B (responders) or by INCB054707 Dose C (partial or nonresponders) for 24 weeks (Period 2).
Placebo
Oral; Tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
INCB054707
Oral; Tablet
Placebo
Oral; Tablet
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Inadequate response or intolerant to ongoing or prior PN therapy.
* ≥ 20 pruriginous lesions on ≥ 2 different body regions at screening and Day 1.
* Willingness to avoid pregnancy or fathering children
Exclusion Criteria
* Current use of a medication known to cause pruritus.
* Women who are pregnant (or who are considering pregnancy) or lactating.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
* Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
* Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.
* Laboratory values outside of the protocol-defined ranges.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Incyte Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kathleen Butler, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Investigative Site US010
Phoenix, Arizona, United States
Investigative Site US024
Phoenix, Arizona, United States
Investigative Site US001
Fountain Valley, California, United States
Investigative Site US014
Sacramento, California, United States
Investigative Site US019
Fort Lauderdale, Florida, United States
Investigative Site US016
Miami, Florida, United States
Investigative Site US013
Miramar, Florida, United States
Investigative Site US009
Tampa, Florida, United States
Investigative Site 1071320
Newnan, Georgia, United States
Investigative Site US008
Plainfield, Indiana, United States
Investigative Site US011
South Bend, Indiana, United States
Investigative Site US003
Baltimore, Maryland, United States
Investigative Site US017
Troy, Michigan, United States
Investigative Site US006
Saint Joseph, Missouri, United States
Investigative Site US004
Portsmouth, New Hampshire, United States
Investigative Site US023
Athens, Ohio, United States
Investigative Site US002
Dublin, Ohio, United States
Investigative Site US012
Gahanna, Ohio, United States
Investigative Site US022
Murfreesboro, Tennessee, United States
Investigative Site US021
Arlington, Texas, United States
Investigative Site US005
Austin, Texas, United States
Investigative Site US018
Dallas, Texas, United States
Investigative Site US007
Houston, Texas, United States
Investigative Site CA002
Edmonton, Alberta, Canada
Investigative Site CA001
Surrey, British Columbia, Canada
Investigative Site CA004
London, Ontario, Canada
Investigative Site CA003
Québec, Quebec, Canada
Investigative Site DE007
Bad Bentheim, , Germany
Investigative Site DE005
Berlin, , Germany
Investigative Site DE004
Bonn, , Germany
Investigative Site DE003
Frankfurt am Main, , Germany
Investigative Site DE001
Hamburg, , Germany
Investigative Site DE002
Münster, , Germany
Investigative Site DE008
Tübingen, , Germany
Investigative Site PL005
Kielce, , Poland
Investigative Site PL003
Osielsko, , Poland
Investigative Site PL001
Rzeszów, , Poland
Investigative Site PL004
Torun, , Poland
Investigative Site PL002
Wroclaw, , Poland
Investigative Site PR002
Caguas, , Puerto Rico
Investigative Site PR001
San Juan, , Puerto Rico
Investigative Site ES004
Alicante, , Spain
Investigative Site ES007
Badalona, , Spain
Investigative Site ES001
Barcelona, , Spain
Investigative Site ES002
Córdoba, , Spain
Investigative Site ES006
Granada, , Spain
Investigative Site ES008
Madrid, , Spain
Investigative Site ES003
Madrid, , Spain
Investigative Site ES005
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-006329-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 54707-206
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.