A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis

The purpose of this study is to evaluate the efficacy and safety of INCB054707 in participants with prurigo nodularis over a 16-week double-blind placebo-controlled treatment period, followed by a 24 -week single blind extension period.

Study Overview

• Status: Completed
• Conditions: Prurigo Nodularis
• Intervention / Treatment: Drug: INCB054707; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1W 4R4
    • Investigative Site CA003
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1C3
      • Investigative Site CA002
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Investigative Site CA001
  • Ontario
    • London, Ontario, Canada, N6A 5R9
      • Investigative Site CA004
• Germany
  • Bad Bentheim, Germany, 48455
    • Investigative Site DE007
  • Berlin, Germany, 10117
    • Investigative Site DE005
  • Bonn, Germany, 53127
    • Investigative Site DE004
  • Frankfurt Am Main, Germany, 60590
    • Investigative Site DE003
  • Hamburg, Germany, 20246
    • Investigative Site DE001
  • Muenster, Germany, 48149
    • Investigative Site DE002
  • Tubingen, Germany, 72076
    • Investigative Site DE008
• Poland
  • Kielce, Poland, 253016
    • Investigative Site PL005
  • Osielsko, Poland, 86-031
    • Investigative Site PL003
  • Rzeszow, Poland, 35-055
    • Investigative Site PL001
  • Torun, Poland, 87100
    • Investigative Site PL004
  • Wroclaw, Poland, 50-566
    • Investigative Site PL002
• Puerto Rico
  • Caguas, Puerto Rico, 00727
    • Investigative Site PR002
  • San Juan, Puerto Rico, 00917
    • Investigative Site PR001
• Spain
  • Alicante, Spain, 03010
    • Investigative Site ES004
  • Badalona, Spain, 08916
    • Investigative Site ES007
  • Barcelona, Spain, 08036
    • Investigative Site ES001
  • Cordoba, Spain, 14004
    • Investigative Site ES002
  • Granada, Spain, 18014
    • Investigative Site ES006
  • Madrid, Spain, 28041
    • Investigative Site ES008
  • Madrid, Spain, 28223
    • Investigative Site ES003
  • Valencia, Spain, 46026
    • Investigative Site ES005
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Investigative Site US010
    • Phoenix, Arizona, United States, 85018
      • Investigative Site US024
  • California
    • Fountain Valley, California, United States, 92708
      • Investigative Site US001
    • Sacramento, California, United States, 95816
      • Investigative Site US014
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Investigative Site US019
    • Miami, Florida, United States, 33175
      • Investigative Site US016
    • Miramar, Florida, United States, 33027
      • Investigative Site US013
    • Tampa, Florida, United States, 33609-2231
      • Investigative Site US009
  • Georgia
    • Newnan, Georgia, United States, 30263
      • Investigative Site 1071320
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • Investigative Site US008
    • South Bend, Indiana, United States, 46617
      • Investigative Site US011
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Investigative Site US003
  • Michigan
    • Troy, Michigan, United States, 48084
      • Investigative Site US017
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Investigative Site US006
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Investigative Site US004
  • Ohio
    • Athens, Ohio, United States, 45701
      • Investigative Site US023
    • Dublin, Ohio, United States, 43016
      • Investigative Site US002
    • Gahanna, Ohio, United States, 43230
      • Investigative Site US012
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • Investigative Site US022
  • Texas
    • Arlington, Texas, United States, 76011
      • Investigative Site US021
    • Austin, Texas, United States, 78745
      • Investigative Site US005
    • Dallas, Texas, United States, 75231
      • Investigative Site US018
    • Houston, Texas, United States, 77004
      • Investigative Site US007

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical diagnosis of PN for at least 3 months before screening.
• 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
• Further inclusion criteria apply.

Exclusion Criteria:

• Have chronic pruritus due to a condition other than PN; have neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis.
• 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.
• Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: INCB054707; Oral; Tablet; Other Names: Povorcitinib
Experimental: 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).	Drug: INCB054707; Oral; Tablet; Other Names: Povorcitinib
Experimental: 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).	Drug: INCB054707; Oral; Tablet; Other Names: Povorcitinib
Placebo Comparator: 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).	Drug: Placebo; Oral; Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16	Each evening, the participants assessed their worst level of itch during the past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable). The Baseline Itch NRS score was determined by averaging the 7 daily Itch NRS scores before Day 1 (i.e., Day -7 to Day -1). If ≥4 of the 7 days of the daily Itch NRS scores were missing prior to Day 1, then the Baseline Itch NRS score was set to "missing." The by-visit Itch NRS score for postbaseline visits was determined by averaging the 7 daily Itch NRS scores before the visit day. If 4 or more daily Itch NRS scores out of the 7 days before the visit day were missing, the Itch NRS score at the visit was set to missing.	Baseline; Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) (IGA Score of 0 or 1 With a ≥2-grade Improvement From Baseline) at Week 16	The IGA for chronic prurigo considers the number of pruriginous lesions, which includes papules, nodules, plaques, umbilicated ulcers, and ulcers, and uses them as an overall severity rating on a scale of 0 to 4. 0: clear; no pruriginous lesions (0 lesions). 1: almost clear; rare palpable pruriginous lesions (approximately 1-5 lesions). 2: mild; few palpable pruriginous lesions (approximately 6-19 lesions). 3: moderate: many palpable pruriginous lesions (approximately 20-100 lesions). 4: severe; abundant palpable pruriginous lesions (over 100 lesions). The IGA-TS is defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline.	Baseline; Week 16
Time to ≥4-point Improvement From Baseline in Itch NRS Score	Each evening, the participants assessed their worst level of itch during the past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable). The Baseline Itch NRS score was determined by averaging the 7 daily Itch NRS scores before Day 1 (i.e., Day -7 to Day -1). If ≥4 of the 7 days of the daily Itch NRS scores were missing prior to Day 1, then the Baseline Itch NRS score was set to "missing." The by-visit Itch NRS score for postbaseline visits was determined by averaging the 7 daily Itch NRS scores before the visit day. If 4 or more daily Itch NRS scores out of the 7 days before the visit day were missing, the Itch NRS score at the visit was set to missing.	up to 122 days
PC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug.	up to 152 days
PC Period: Number of Participants With Any ≥Grade 3 TEAE	A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and serious adverse event (SAE) reported during the study and assigned it to 1 of the following categories. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.	up to 152 days
Extension Period: Number of Participants With Any TEAE	An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug.	up to 215 days
Extension Period: Number of Participants With Any ≥Grade 3 TEAE	A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and serious adverse event (SAE) reported during the study and assigned it to 1 of the following categories. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.	up to 215 days

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Kathleen Butler, MD, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Actual): August 11, 2023
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Prurigo nodularis; PN; INCB054707; chronic pruritus
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Prurigo; Neurodermatitis
• Other Study ID Numbers: INCB 54707-206; 2021-006329-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No