Adults aged 18 or over with a clinical diagnosis of prurigo nodularis (PN) for at least 3 months may qualify for this study. Eligible individuals must meet all inclusion criteria including having 6 or more pruriginous lesions on more than 2 different body areas. The total estimated impacted body surface area (BSA) must be 20% or less.
Participants will receive investigational topical treatment (active study drug) or placebo. Study treatment and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.
Study participation will last approximately 56 weeks and involve about 12 visits to the study centre.
Toronto - Toronto Research Centre
London - DermEffects
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Last Update Posted: December 10, 2023
NCT05755438
Incyte Corporation
Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
Condition or Disease:
Prurigo
Intervention/Treatment:
Drug: Vehicle CreamPhase:
Phase 3
Ages Eligible for Study:
18 Years and 99 Years (Adult)
Sexes Eligible for Study:
All
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:
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.
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