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Активно (без набиране) Фаза 3 NCT06527404

A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis

Фаза 3 – широко изпитване преди одобрение
Заболявания: Prurigo Nodularis

Спонсор: Amgen

Налично на: БГ
Обобщение
The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).
Кой може да участва
Inclusion Criteria: * Age ≥ 18 years (or any legal adult age within the country if it is older than 18 years) * Clinical Diagnosis of Prurigo Nodularis that has been present for at least 3 months. * Patient-reported average Daily Itch Score based on electronic daily diary assessment the last 7 days prior to and including day 1. * Has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs and /or arms and /or trunk. * History of inadequate response to topical therapies of medium or higher potency or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks). Exclusion Criteria: * Skin or systemic morbidities, other than prurigo nodularis, that have been active within the last 3 months that interfere with assessment of study outcomes including but not limited to atopic dermatitis (signs or symptoms other than dry skin or requiring treatment is not allowed; use of emollients and/or history of AD is allowed). * Prurigo nodularis secondary to medications. * Prurigo nodularis secondary to neurologic or psychiatric medical conditions. * Treatment with any systemic biologic immunosuppressive or systemic biologic immunomodulatory therapy for prurigo nodularis or any other autoimmune, inflammatory, or allergic disease within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 prerandomization. * Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 prerandomization.
Места на провеждане 27
Argentina (1)
Hospital Universitario Austral
Derqui, Pilar , Buenos Aires
Австралия (1)
St George Dermatology and Skin Cancer Centre
Kogarah , New South Wales
Белгия (1)
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels
Бразилия (1)
Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
Salvador , Estado de Bahia
Канада (1)
Doctor Chih-Ho Hong Medical Incorporated
Surrey , British Columbia
Chile (1)
Enroll SpA
Providencia , Santiago Metropolitan
Китай (1)
Peking University First Hospital
Beijing , Beijing Municipality
Финландия (1)
Clinical Research Services Helsinki
Helsinki
Франция (1)
Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan
Brest
Германия (1)
Universitaetsklinikum Augsburg
Augsburg
Гърция (1)
University General Hospital Attikon
Athens
Hong Kong (1)
Queen Mary Hospital, The University of Hong Kong
Hong Kong
Унгария (1)
Obudai Egeszsegugyi Centrum Kft
Budapest
Италия (1)
Ospedale San Salvatore
LAquila
Япония (1)
Fujita Health University Hospital
Toyoake-shi , Aichi-ken
Latvia (1)
J Kisis
Riga
Mexico (1)
Clínica de Enfermedades Crónicas y de Procedimientos Especiales
Morelia , Michoacán
Нидерландия (1)
Universitair Medisch Centrum Utrecht
Utrecht
Полша (1)
Niepubliczny Zaklad Opieki Zdrowotnej
Bialystok
Румъния (1)
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca
Южна Корея (1)
Korea University Ansan Hospital
Ansansi, Gyeonggido
Испания (1)
Hospital Universitario Reina Sofia
Córdoba , Andalusia
Швеция (1)
Diagnostiskt Centrum Hud i Sickla
Nacka
Taiwan (1)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Турция (1)
Ankara Bilkent Sehir Hastanesi
Ankara
Великобритания (1)
Queen Elizabeth University Hospital
Glasgow
САЩ (1)
University of Alabama at Birmingham
Birmingham , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
100 Years
Здрави доброволци
Не
Начална дата
18.07.2024
Крайна дата
17.01.2027
Регистрационен номер
NCT06527404
Източник
anzctr
Запитване за медицински туризъм

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