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

Last updated: May 22, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Not Recruiting

Phase

1

Condition

Dermatitis, Atopic

Warts

Atopic Dermatitis

Treatment

Ruxolitinib Cream 1.5%

Clinical Study ID

NCT06213831
INCB18424-110
  • Ages 18-65
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of PN ≥ 3 months before screening.

  • Pruriginous lesions (defined as papules, nodules, plaques, umbilicated lesions, andlinear lesions) on ≥ 2 different body areas (such as right and left leg) atscreening 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-dayaverage of WI-NRS scores before Day 1 (data from a minimum of 4 out of 7 days priorto Day 1 is needed).

Exclusion

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 ofscreening and baseline.

  • Acute or chronic active HBV or HCV infection.

  • Any underlying condition known to be associated with the clinical presentation of PNthat is not under control (stable) prior to the baseline visit.

  • Any serious illness or medical, physical, or psychiatric condition(s) that, in theinvestigator's opinion, would interfere with full participation in the study,including administration of study cream and attending required study visits; pose asignificant risk to the participant; or interfere with interpretation of study data.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Design

Total Participants: 23
Treatment Group(s): 1
Primary Treatment: Ruxolitinib Cream 1.5%
Phase: 1
Study Start date:
February 27, 2024
Estimated Completion Date:
August 20, 2025

Connect with a study center

  • Saguaro Dermatology

    Phoenix, Arizona 85008
    United States

    Site Not Available

  • Affiliated Dermatology

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • First Oc Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Amicis Research Center Valencia

    Northridge, California 91324
    United States

    Site Not Available

  • Clinical Science Institute Clinical Research Specialists Inc

    Santa Monica, California 90404
    United States

    Site Not Available

  • Olympian Clinical Research

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Advanced Pharma Cr, Llc

    Miami, Florida 33147
    United States

    Site Not Available

  • Sullivan Dermatology North Miami Beach Office

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • International Clinical Research Tennessee Llc

    Sanford, Florida 32771
    United States

    Site Not Available

  • Olympian Clinical Research

    Tampa, Florida 33615
    United States

    Site Not Available

  • Lane Dermatology and Dermatologic Surgery

    Columbus, Georgia 31904
    United States

    Site Not Available

  • St Lukes Clinic Dermatology Ketchum

    Ketchum, Idaho 83340
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group Llc

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Equity Medical

    Bowling Green, Kentucky 42104
    United States

    Site Not Available

  • Oakland Hills Dermatology Pc

    Auburn Hills, Michigan 48326
    United States

    Site Not Available

  • Revival Research Institute, Llc Troy

    Troy, Michigan 48084
    United States

    Site Not Available

  • Equity Medical, Llc

    New York, New York 10023
    United States

    Site Not Available

  • Icahn School of Medicine At Mount Sinai

    New York, New York 10023
    United States

    Site Not Available

  • Red River Research Partners

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Central Sooner Research

    Oklahoma City, Oklahoma 73170
    United States

    Site Not Available

  • Paddington Testing Co Inc

    Philadelphia, Pennsylvania 19103
    United States

    Site Not Available

  • Advanced Dermatology and Cosmetic Surgery Spartanburg

    Spartanburg, South Carolina 29307
    United States

    Site Not Available

  • International Clinical Research Tennessee Llc

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • Dermresearch, Inc.

    Austin, Texas 78759
    United States

    Site Not Available

  • North Texas Center For Clinical Research Ntccr

    Frisco, Texas 75034
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.