A Study to Evaluate the Safety and Tolerability of Maximal Use Ruxolitinib Cream

A Maximal Use Trial of Ruxolitinib Cream in Adult Participants With Prurigo Nodularis

This study is being conducted to determine the safety and tolerability of ruxolitinib 1.5% cream under maximal use conditions in participants with Prurigo Nodularis (PN).

Study Overview

• Status: Completed
• Conditions: Prurigo Nodularis
• Intervention / Treatment: Drug: Ruxolitinib Cream 1.5%

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Saguaro Dermatology
    • Scottsdale, Arizona, United States, 85255
      • Affiliated Dermatology
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Northridge, California, United States, 91324
      • Amicis Research Center Valencia
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute Clinical Research Specialists Inc
  • Florida
    • Miami, Florida, United States, 33147
      • Advanced Pharma CR, LLC
    • North Miami Beach, Florida, United States, 33162
      • Sullivan Dermatology North Miami Beach Office
    • Tampa, Florida, United States, 33615
      • Olympian Clinical Research
  • Idaho
    • Ketchum, Idaho, United States, 83340
      • St Lukes Clinic Dermatology Ketchum
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group LLC
  • Kentucky
    • Bowling Green, Kentucky, United States, 42104
      • Equity Medical
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Oakland Hills Dermatology Pc
    • Troy, Michigan, United States, 48084
      • Revival Research Institute, Llc Troy
  • New York
    • New York, New York, United States, 10023
      • Equity Medical, LLC
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Red River Research Partners
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73170
      • Central Sooner Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Co Inc
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • International Clinical Research Tennessee Llc
  • Texas
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.
    • Frisco, Texas, United States, 75034
      • North Texas Center For Clinical Research Ntccr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical diagnosis of PN ≥ 3 months before screening.
• Pruriginous lesions (defined as papules, nodules, plaques, umbilicated lesions, and linear lesions) on ≥ 2 different body areas (such as right and left leg) at screening and baseline.
• Total estimated treatment BSA ≥ 25% (excluding the scalp) at screening and baseline.
• IGA-CPG-S score of ≥ 2 at screening and baseline.
• Baseline PN-related WI-NRS score ≥ 7. Baseline WI-NRS score is defined as the 7-day average of WI-NRS scores before Day 1 (data from a minimum of 4 out of 7 days prior to Day 1 is needed).

Exclusion Criteria:

• Chronic or acute pruritus due to a condition other than PN.
• Active AD lesions (signs and symptoms other than dry skin) within 6 months of screening and baseline.
• Acute or chronic active HBV or HCV infection.
• Any underlying condition known to be associated with the clinical presentation of PN that is not under control (stable) prior to the baseline visit.
• Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maximal Use Ruxolitinib 1.5%; Participants will apply ruxolitinib 1.5% cream BID through Week 4 to all pruriginous lesions. At Week 4, participants who have completed 4 weeks of treatment with no safety concerns may enter the optional 4-week treatment extension period, during which all participants will apply ruxolitinib 1.5% cream BID to existing pruriginous lesions.	Drug: Ruxolitinib Cream 1.5%; Ruxolitinib Cream 1.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Treatment-emergent Adverse Events (TEAEs)	Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.	Up to 16 weeks, including 30 days of safety follow-up
Number of participants with TEAEs leading to dose interruption or discontinuation	Number of participants with TEAEs leading to dose interruption or discontinuation.	Up to 16 weeks, including 30 days of safety follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ruxolitinib pharmacokinetic (PK) parameters in plasma	Ruxolitinib concentration in plasma.	Up to 16 weeks, including 30 days of safety follow-up

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Incyte Medical Monitor, Incyte Corporation

Publications and helpful links

Helpful Links

• A study to evaluate the safety and tolerability of maximal use Ruxolitinib Cream

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Actual): July 17, 2025
• Study Completion (Actual): July 17, 2025

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: ruxolitinib; PN; Prurigo Nodularis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Prurigo; Neurodermatitis
• Other Study ID Numbers: INCB18424-110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• 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
• product manufactured in and exported from the U.S.: Yes