For Healthcare Professionals

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

clipboard-pencil

About the study

The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

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

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Chronic pruritus due to a condition other than PN
  2. Total estimated BSA treatment area (excluding the scalp) > 20%.
  3. Neuropathic and psychogenic pruritus
  4. Active atopic dermatitis lesions within 3 months of screening and baseline.
  5. Uncontrolled thyroid function
  6. 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.
  7. Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching.
  8. 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
  9. Pregnant or lactating, or considering pregnancy.
  10. History of alcoholism or drug addiction within 1 year
  11. Known allergy or reaction to any of the components of the study drug.
  12. Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities.
  13. Employees of the sponsor or investigator or otherwise dependents of them.
  14. The following participants are excluded in France:
  1. Vulnerable populations according to article L.1121-6 of the French Public Health Code.
  2. Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.
  3. Individuals not affiliated with the social security system.
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1.855.463.3463Email iconEmail Study Center

Study Details


Contition

Prurigo Nodularis

Age

18 - 99

Phase

PHASE3

Participants Needed

180

Est. Completion Date

Aug 5, 2025

Treatment Type

INTERVENTIONAL


Sponsor

Incyte Corporation

ClinicalTrials.gov NCT Identifier

NCT05764161

Study Number

INCB 18424-320

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to create a personal profile and 
receive news, resources, and alerts 
about clinical trials related to your conditions of interest.