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

NCT05061693 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: INCB 54707-2062021-006329-23
• Study Type: interventional
• Target: 146
• Locations: 6 countries
• Sites: 49

Brief Summary

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.

Conditions

Prurigo Nodularis

Keywords

Prurigo nodularis; PN; INCB054707; chronic pruritus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  Baseline; Week 16

• Time to ≥4-point Improvement From Baseline in Itch NRS Score

  up to 122 days

• PC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

  up to 152 days

• PC Period: Number of Participants With Any ≥Grade 3 TEAE

  up to 152 days

• Extension Period: Number of Participants With Any TEAE

  up to 215 days

Study Arms (4)

INCB054707 Dose A

EXPERIMENTAL

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

INCB054707 Dose B

EXPERIMENTAL

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

INCB054707 Dose C

EXPERIMENTAL

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

Placebo followed by INCB054707 Dose B or C

PLACEBO COMPARATOR

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

Interventions

INCB054707 DRUG

Oral; Tablet

Also known as: Povorcitinib

INCB054707 Dose A; INCB054707 Dose B; INCB054707 Dose C

Placebo DRUG

Oral; Tablet

Placebo followed by INCB054707 Dose B or C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (49)

Investigative Site US010

Phoenix, Arizona, 85006, United States

Location

Investigative Site US024

Phoenix, Arizona, 85018, United States

Location

Investigative Site US001

Fountain Valley, California, 92708, United States

Location

Investigative Site US014

Sacramento, California, 95816, United States

Location

Investigative Site US019

Fort Lauderdale, Florida, 33308, United States

Location

Investigative Site US016

Miami, Florida, 33175, United States

Location

Investigative Site US013

Miramar, Florida, 33027, United States

Location

Investigative Site US009

Tampa, Florida, 33609-2231, United States

Location

Investigative Site 1071320

Newnan, Georgia, 30263, United States

Location

Investigative Site US008

Plainfield, Indiana, 46168, United States

Location

Investigative Site US011

South Bend, Indiana, 46617, United States

Location

Investigative Site US003

Baltimore, Maryland, 21287, United States

Location

Investigative Site US017

Troy, Michigan, 48084, United States

Location

Investigative Site US006

Saint Joseph, Missouri, 64506, United States

Location

Investigative Site US004

Portsmouth, New Hampshire, 03801, United States

Location

Investigative Site US023

Athens, Ohio, 45701, United States

Location

Investigative Site US002

Dublin, Ohio, 43016, United States

Location

Investigative Site US012

Gahanna, Ohio, 43230, United States

Location

Investigative Site US022

Murfreesboro, Tennessee, 37130, United States

Location

Investigative Site US021

Arlington, Texas, 76011, United States

Location

Investigative Site US005

Austin, Texas, 78745, United States

Location

Investigative Site US018

Dallas, Texas, 75231, United States

Location

Investigative Site US007

Houston, Texas, 77004, United States

Location

Investigative Site CA002

Edmonton, Alberta, T6G 1C3, Canada

Location

Investigative Site CA001

Surrey, British Columbia, V3R 6A7, Canada

Location

Investigative Site CA004

London, Ontario, N6A 5R9, Canada

Location

Investigative Site CA003

Québec, Quebec, G1W 4R4, Canada

Location

Investigative Site DE007

Bad Bentheim, 48455, Germany

Location

Investigative Site DE005

Berlin, 10117, Germany

Location

Investigative Site DE004

Bonn, 53127, Germany

Location

Investigative Site DE003

Frankfurt am Main, 60590, Germany

Location

Investigative Site DE001

Hamburg, 20246, Germany

Location

Investigative Site DE002

Münster, 48149, Germany

Location

Investigative Site DE008

Tübingen, 72076, Germany

Location

Investigative Site PL005

Kielce, 253016, Poland

Location

Investigative Site PL003

Osielsko, 86-031, Poland

Location

Investigative Site PL001

Rzeszów, 35-055, Poland

Location

Investigative Site PL004

Torun, 87100, Poland

Location

Investigative Site PL002

Wroclaw, 50-566, Poland

Location

Investigative Site PR002

Caguas, 00727, Puerto Rico

Location

Investigative Site PR001

San Juan, 00917, Puerto Rico

Location

Investigative Site ES004

Alicante, 03010, Spain

Location

Investigative Site ES007

Badalona, 08916, Spain

Location

Investigative Site ES001

Barcelona, 08036, Spain

Location

Investigative Site ES002

Córdoba, 14004, Spain

Location

Investigative Site ES006

Granada, 18014, Spain

Location

Investigative Site ES008

Madrid, 28041, Spain

Location

Investigative Site ES003

Madrid, 28223, Spain

Location

Investigative Site ES005

Valencia, 46026, Spain

Location

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Kathleen Butler, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 29, 2021
• Study Start: November 4, 2021
• Primary Completion: August 11, 2023
• Study Completion: February 28, 2024
• Last Updated: July 11, 2025
• Results First Posted: August 27, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• 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.

Locations

PR (2); US (23); PL (5); DE (7); ES (8); CA (4)