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

Completed · Phase 3

Conditions studied: Prurigo

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

NCT05755438

Run by

Incyte Corporation

People needed

204

Starts

2023-03-10

Expected to finish

2025-08-13

Last updated by the study team

2025-11-14

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

• Medical Dermatology Specialists Phoenix — Phoenix, Arizona, United States
• Johnson Dermatology — Fort Smith, Arkansas, United States
• First Oc Dermatology — Fountain Valley, California, United States
• Dermatology Associates Pc — Rockville, Maryland, United States
• Clarkston Medical Group — Clarkston, Michigan, United States
• Revival Research Institute, Llc Troy — Troy, Michigan, United States
• Medisearch Clinical Trials — Saint Joseph, Missouri, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• UC Health, Llc — Cincinnati, Ohio, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Central Sooner Research — Norman, Oklahoma, United States
• Dermatology Associates of Plymouth Meeting — Plymouth Meeting, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• International Clinical Research Tennessee Llc — Murfreesboro, Tennessee, United States
• North Texas Center For Clinical Research Ntccr — Frisco, Texas, United States
• Austin Institute For Clinical Research Aicr Pflugerville — Pflugerville, Texas, United States
• Center For Clinical Studies — Webster, Texas, United States
• Premier Clinical Research — Spokane, Washington, United States
• Conexa Investigacion Clinica S.A. — Buenos Aires, Argentina
• Cedic Centro de Investigaciones Clinicas — Ciudad Autonoma Buenos Aires, Argentina
• Psoriahue-Medicina Interdisciplinar — Ciudad Autonoma Buenos Aires, Argentina
• Centro de Investigaciones Medicas Mar Del Plata — Mar del Plata, Argentina
• Fundacion Scherbovsky — Mendoza, Argentina
• Instituto de Especialidades de La Salud Rosario — Rosario, Argentina
• Buenos Aires Skin — Ciudad Autonoma Buenos Aires, Argentina

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.