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

NCT05755438

CompletedPhase 3

Sponsor: Incyte Corporation

Conditions: Prurigo

Interventions: Ruxolitinib Cream, Vehicle Cream

Countries: United States, Argentina, Belgium, Canada, Chile, France, Germany, Italy

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

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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:

  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.
Locations (71)
  • Phoenix, Arizona, United States
  • Fort Smith, Arkansas, United States
  • Fountain Valley, California, United States
  • Rockville, Maryland, United States
  • Clarkston, Michigan, United States
  • Troy, Michigan, United States
  • Saint Joseph, Missouri, United States
  • Winston-Salem, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Cleveland, Ohio, United States
  • Norman, Oklahoma, United States
  • Plymouth Meeting, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Murfreesboro, Tennessee, United States
  • Frisco, Texas, United States
  • Pflugerville, Texas, United States
  • Webster, Texas, United States
  • Spokane, Washington, United States
  • Buenos Aires, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Mar del Plata, Argentina
  • Mendoza, Argentina
  • Rosario, Argentina
  • San Miguel de Tucumán, Argentina
  • Brussels, Belgium
  • Brussels, Belgium
  • Ghent, Belgium
  • Ghent, Belgium
  • + 41 more on CT.gov