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Active (not recruiting) Phase 3 NCT06527404

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

Phase 3 – large-scale trial before approval
Conditions: Prurigo Nodularis

Sponsor: Amgen

trial.available_in: БГ
Overview
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).
Who can participate
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.
Locations 27
Argentina (1)
Hospital Universitario Austral
Derqui, Pilar , Buenos Aires
Australia (1)
St George Dermatology and Skin Cancer Centre
Kogarah , New South Wales
Belgium (1)
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels
Brazil (1)
Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
Salvador , Estado de Bahia
Canada (1)
Doctor Chih-Ho Hong Medical Incorporated
Surrey , British Columbia
Chile (1)
Enroll SpA
Providencia , Santiago Metropolitan
China (1)
Peking University First Hospital
Beijing , Beijing Municipality
Finland (1)
Clinical Research Services Helsinki
Helsinki
France (1)
Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan
Brest
Germany (1)
Universitaetsklinikum Augsburg
Augsburg
Greece (1)
University General Hospital Attikon
Athens
Hong Kong (1)
Queen Mary Hospital, The University of Hong Kong
Hong Kong
Hungary (1)
Obudai Egeszsegugyi Centrum Kft
Budapest
Italy (1)
Ospedale San Salvatore
LAquila
Japan (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
Netherlands (1)
Universitair Medisch Centrum Utrecht
Utrecht
Poland (1)
Niepubliczny Zaklad Opieki Zdrowotnej
Bialystok
Romania (1)
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca
South Korea (1)
Korea University Ansan Hospital
Ansansi, Gyeonggido
Spain (1)
Hospital Universitario Reina Sofia
Córdoba , Andalusia
Sweden (1)
Diagnostiskt Centrum Hud i Sickla
Nacka
Taiwan (1)
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Turkey (1)
Ankara Bilkent Sehir Hastanesi
Ankara
United Kingdom (1)
Queen Elizabeth University Hospital
Glasgow
United States (1)
University of Alabama at Birmingham
Birmingham , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
18.07.2024
Completion date
17.01.2027
Registry ID
NCT06527404
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.