AZ Sint-Lucas | Center for Clinical Studies
Status and phase
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About
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
Full description
The study comprises of a 12 week double-blind, vehicle-controlled (DBVC) treatment period, followed by a 40 week open label extension period, and 30 day safety follow-up period During the double blind period, all PN-affected areas identified at baseline will be treated, and during the open label period, only active PN-affected areas will be treated.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
Primary purpose
Allocation
Interventional model
Masking
204 participants in 2 patient groups, including a placebo group
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Central trial contact
Incyte Corporation Call Center (US); Incyte Corporation Call Center (ex-US)
Data sourced from clinicaltrials.gov
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