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

Completed · Phase 1

Conditions studied: Prurigo Nodularis

In brief

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).

Key facts

Study ID

NCT06213831

Run by

Incyte Corporation

People needed

23

Starts

2024-02-27

Expected to finish

2025-07-17

Last updated by the study team

2025-08-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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
• Equity Medical — Bowling Green, Kentucky, United States
• Oakland Hills Dermatology Pc — Auburn Hills, Michigan, United States
• Revival Research Institute, Llc Troy — Troy, Michigan, United States
• Equity Medical, Llc — New York, New York, United States
• Red River Research Partners — Fargo, North Dakota, United States
• Central Sooner Research — Oklahoma City, Oklahoma, United States
• Paddington Testing Co Inc — Philadelphia, Pennsylvania, United States
• International Clinical Research Tennessee Llc — Murfreesboro, Tennessee, United States
• Dermresearch, Inc. — Austin, Texas, United States
• North Texas Center For Clinical Research Ntccr — Frisco, Texas, United States

Full record on ClinicalTrials.gov

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