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A Study to Evaluate the Safety and Tolerability of Maximal Use Ruxolitinib Cream | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT06213831•Incyte Corporation

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (20)

Saguaro Dermatology

Phoenix, Arizona, United States

Affiliated Dermatology

Scottsdale, Arizona, United States

First Oc Dermatology

Fountain Valley, California, United States

Amicis Research Center Valencia

Northridge, California, United States

Clinical Science Institute Clinical Research Specialists Inc

Santa Monica, California, United States

Advanced Pharma Cr, Llc

Miami, Florida, United States

Sullivan Dermatology North Miami Beach Office

North Miami Beach, Florida, United States

Olympian Clinical Research

Tampa, Florida, United States

St Lukes Clinic Dermatology Ketchum

Ketchum, Idaho, United States

Dawes Fretzin Clinical Research Group Llc

Indianapolis, Indiana, United States

Key Dates

Start Date

February 27, 2024

Primary Completion Date

July 17, 2025

Completion Date

July 17, 2025

Last Updated

August 13, 2025

Enrollment

ACTUAL participants

Conditions

Prurigo Nodularis

Interventions

Ruxolitinib Cream 1.5%

DRUG

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

NCT06342713

Healthy ParticipantsHealthy Subjects+5 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)

NCT06516952

Prurigo Nodularis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

A Study to Evaluate the Efficacy and Safety Study of Povorcitinib in Participants With Prurigo Nodularis (STOP-PN1)

Phase III Clinical Study of MG-K10 Humanized Mab Injection in Subjects With Prurigo Nodularis

A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

Effect of EMD Protocol for Urge on Dermatology-specific Quality of Life

Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis