Estudio de Fase 3, Aleatorizado, Doble Ciego, Controlado con Placebo, de Eficacia y Seguridad de Povorcitinib en Participantes con Prurigo Nodular

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06516952Tipo: INTERVENTIONALInicio: 10 de oct de 2024Fin estimado: 3 de may de 2027

Resumen

El propósito de este estudio es evaluar el efecto de povorcitinib sobre el prurito y las lesiones cutáneas en participantes con prurigo nodular.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Male and female participants 18 to 75 years of age.
Clinical diagnosis of PN for at least 3 months prior to Screening visit.
Pruritus, defined as an average Itch NRS score ≥ 7 during the 7 days prior to Day 1/Baseline.
Total of ≥ 20 pruriginous lesions on ≥ 2 different body regions (both legs, and/or both arms, and/or trunk) at Screening and Day 1/Baseline.
Documented history of treatment failure, demonstrated intolerance, or contraindication to a previous PN treatment.
Willingness to avoid pregnancy or fathering children.

Criterios de exclusión

Chronic pruritus due to a condition other than PN or neuropathic and psychogenic pruritus.
Diagnosis of PN secondary to medications.
Active AD lesions (signs and symptoms other than dry skin) within 3 months prior to Screening visit.
Women who are pregnant (or are considering pregnancy) or breastfeeding.
Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
Evidence of infection with TB, HBV, HCV or HIV.
History of failure to any topical or systemic JAK or TYK2 inhibitor as treatment of PN or any inflammatory disease.
Laboratory values outside of the protocol-defined ranges.

Intervenciones

drug

Povorcitinib

Oral Tablet

drug

Placebo

Oral Tablet

Ubicaciones

Conexa Investigacion Clinica S.A.

Buenos Aires, Argentina

RECRUITING

Cedic - Centro de Investigacion Clinica

Buenos Aires, Argentina

RECRUITING

Instituto de Neumonologia Y Dermatologia

Buenos Aires, Argentina

NOT_YET_RECRUITING

Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias (Inaer)

Buenos Aires, Argentina

RECRUITING

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, Argentina

RECRUITING

Instituto Especialidades de La Salud Rosario - Clinica Del Torax

Rosario, Argentina

RECRUITING

Investigaciones Reumatologicas Tucuman S.R.L.

San Miguel de Tucumán, Argentina

RECRUITING

Patrocinadores

PrincipalIncyte Corporation

Contactos

Incyte Corporation Call Center (US)

CONTACT

medinfo@incyte.com 1.855.463.3463

Incyte Corporation Call Center (ex-US)

CONTACT

eumedinfo@incyte.com +800 00027423

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