A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

Completed · Phase 3

Conditions studied: Prurigo Nodularis

In brief

The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).

Key facts

Study ID

NCT05764161

Run by

Incyte Corporation

People needed

190

Starts

2023-06-12

Expected to finish

2025-11-04

Last updated by the study team

2025-12-18

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of PN ≥ 3 months before screening.
• ≥ 6 pruriginous lesions on ≥ 2 different body areas (such as right and left leg) at screening and baseline having a treatment area <20% BSA.
• IGA-CPG-S score of ≥ 2 at screening and baseline.
• Baseline PN-related WI-NRS score ≥ 7.
• Willingness to avoid pregnancy or fathering children.

You may not qualify if…

• Chronic pruritus due to a condition other than PN
• Total estimated BSA treatment area (excluding the scalp) > 20%.
• Neuropathic and psychogenic pruritus
• Active atopic dermatitis lesions within 3 months of screening and baseline.
• Uncontrolled thyroid function
• Concurrent skin or other serious or unstable medical conditions which may interfere with the evaluation of PN such as immunocompromised status, acute/chronic infections, active malignancy, history of TB, history of DVT/VTE, etc Protocol defined abnormal laboratory results.
• Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching.
• Psoralen and ultraviolet A or ultraviolet B therapy within 4 weeks before baseline or Ultraviolet light therapy or prolonged exposure to natural or artificial sources of ultraviolet radiation (within 2 weeks before baseline
• Pregnant or lactating, or considering pregnancy.
• History of alcoholism or drug addiction within 1 year
• Known allergy or reaction to any of the components of the study drug.
• Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities.
• Employees of the sponsor or investigator or otherwise dependents of them.
• The following participants are excluded in France:
• Vulnerable populations according to article L.1121-6 of the French Public Health Code.
• Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.
• Individuals not affiliated with the social security system.

Where it is running

• Northwest Arkansas Clinical Trials Center — Arkansas City, Arkansas, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Clinical Science Institute Clinical Research Specialists Inc — Santa Monica, California, United States
• Cura Clinical Research — Sherman Oaks, California, United States
• Ars - Maitland Clinical Research Unit — Orlando, Florida, United States
• Marietta Dermatology the Skin Cancer Center Marietta — Marietta, Georgia, United States
• The South Bend Clinic Main Campus — South Bend, Indiana, United States
• Axon Clinical Research — Baltimore, Maryland, United States
• Activmed Practices Research, Llc Beverly — Beverly, Massachusetts, United States
• Oakview Dermatology — Athens, Ohio, United States
• Aventiv Research Inc-Dublin — Dublin, Ohio, United States
• Wright State Physicians, Inc. — Fairborn, Ohio, United States
• University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building — Pittsburgh, Pennsylvania, United States
• Dermdox Center For Dermatology — Sugarloaf, Pennsylvania, United States
• Dermresearch, Inc. — Austin, Texas, United States
• Premier Specialists Pty Ltd — Kogarah, New South Wales, Australia
• Liverpool Hospital — Liverpool, New South Wales, Australia
• Holdsworth House Medical Practice — Sydney, New South Wales, Australia
• Westmead Hospital — Sydney, New South Wales, Australia
• Veracity Clinical Research — Woolloongabba, Queensland, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Paratus Clinical Research, Woden — Phillip, Australia
• Landeskrankenhaus Universitatsklinikum Graz — Graz, Austria
• Ordensklinikum Linz Gmbh Elisabethinen — Linz, Austria
• University of Alabama At Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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