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Completed
NCT05764161
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
Conditions: Prurigo Nodularis
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 190
Sponsor: Incyte Corporation
Location: University of Alabama At Birmingham Birmingham Alabama
Summary
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
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%.
* 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.
Source: ClinicalTrials.gov (NCT05764161). StuddyBuddy aggregates publicly available trial information.