A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis

CompletadoFase 3ClinicalTrials.gov

ID: NCT05755438Tipo: INTERVENTIONALInicio: 10 de mar de 2023Fin estimado: 13 de ago de 2025

Traducción no disponible, mostrando original

Resumen

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

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 99 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Ruxolitinib Cream

Ruxolitinib cream 1.5% twice daily (BID) during the vehicle controlled (DBVC)and open label treatment period (OLE).

drug

Vehicle Cream

Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle controlled period (DBVC).

Ubicaciones

Conexa Investigacion Clinica S.A.

Buenos Aires, Argentina

Cedic Centro de Investigaciones Clinicas

Ciudad Autonoma Buenos Aires, Argentina

Buenos Aires Skin

Ciudad Autonoma Buenos Aires, Argentina

Psoriahue-Medicina Interdisciplinar

Ciudad Autonoma Buenos Aires, Argentina

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, Argentina

Fundacion Scherbovsky

Mendoza, Argentina

Instituto de Especialidades de La Salud Rosario

Rosario, Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalIncyte Corporation

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