Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: barzolvolimab, Standard of Care.
- Кому может быть актуально
- Состояния в реестре: Chronic Spontaneous Urticaria. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Аргентина, Австралия, Бельгия, Болгария +14
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Phase 3b Long-term Efficacy and Safety Extension Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria Who Have Completed CDX0159-12 or CDX0159-13
Обзор
The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials. This study will also fulfill the Celldex commitment to provide post-trial access to participants who have completed the phase 3 studies, where applicable.
Подробное описание
This is a global, multicenter, long-term extension phase 3b study to determine the time to disease worsening or treatment failure in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods the phase 3 clinical trials.
The study will consist of 2 Groups: Group 1 (Observation Group), comprising participants whose UAS7 score is less than 16 at entry and Group 2 (Barzolvolimab Retreatment Group) comprising participants whose UAS7 score is 16 or greater.
Participation in this trial will last for approximately 52 weeks for participants assigned to Group 1 (Observation Group) and who do not receive barzolvolimab during the trial. Participants assigned to Group 1 who require barzolvolimab rescue during the trial will be in the trial for up to 68 weeks. Participants assigned to Group 2 (Barzolvolimab Retreatment Group), trial participation will last for approximately 68 weeks from the start of treatment (Day 1).
Вмешательства
- Биопрепарат barzolvolimab
Subcutaneous Administration - Другое Standard of Care
Observational/Standard of Care
Первичные конечные точки
- Time to disease worsening or treatment failure through Week 52 based on the occurrence of UAS7 (Urticaria Activity Score) of 16 or greater. [Срок оценки: From Day 1 (baseline) to Week 52.]
- Time to disease worsening or treatment failure through Week 52 based on the occurrence of the discontinuation of barzolvolimab in Group 2 due to lack of efficacy or to a treatment related adverse event. [Срок оценки: From Day 1 (baseline) to Week 52.]
- Time to disease worsening or treatment failure through Week 52 based on the occurrence of first use of strongly confounding prohibited medication (Group 1 or 2) or use of barzolvolimab in Group 1. [Срок оценки: From Day 1 (baseline) to Week 52.]
Вторичные конечные точки (12)
- Group 1: Change from baseline in Urticaria Activity Score (UAS7) at Week 26. [Срок оценки: From Day 1 (baseline) in phase 3 trial to Week 26.]
- Group 1: Change from baseline in UAS7 at Week 52/End of Study. [Срок оценки: From Day 1 (baseline) in phase 3 trial to Week 52/End of Study.]
- Percentage of Group 1 participants with UAS7 ≤ 6 at week 26. [Срок оценки: From Day 1 (baseline) to Week 26.]
- Percentage of Group 1 participants with UAS7 ≤ 6 at week 52. [Срок оценки: From Day 1 (baseline) to Week 52/End of Study.]
- Percentage of Group 1 participants with UAS7 = 0 at Day 1 who have UAS7 ≤ 6 at Week 26. [Срок оценки: From Day 1 (baseline) to Week 26.]
- Percentage of Group 1 participants with UAS7 = 0 at Day 1 who have UAS7 ≤ 6 at Week 52. [Срок оценки: From Day 1 (baseline) to Week 52/End of Treatment.]
- Group 1: Proportion of participants with complete absence of hives and itch (UAS7 = 0 AAS7 = 0) at Day 1 who maintained complete control at Week 26. [Срок оценки: From Day 1 (baseline) to Week 26.]
- Group 1: Proportion of participants with complete absence of hives and itch (UAS7 = 0 AAS7 = 0) at Day 1 who maintained complete control at Week 52. [Срок оценки: From Day 1 (baseline) to Week 52/End of Study.]
- Group 1: Participants with UAS7 ≤ 6 at Day 1, time to loss of well-controlled disease through Week 52. [Срок оценки: From Day 1 (baseline) to Week 52/End of Study.]
- Group 1: Participants with UAS7 = 0 at Day 1, time to loss of complete controlled disease through Week 52. [Срок оценки: From Day 1 (baseline) to Week 52/End of Study.]
- Group 1: Participants with UAS7 = 0 and AAS7 = 0 at Day 1, time to loss of CSU completely controlled through Week 52. [Срок оценки: From Day 1 (baseline) to Week 52/End of Study.]
- Group 2: Change from baseline in UAS7 at Week 12. [Срок оценки: From Day 1 (baseline) to Week 12.]
Критерии участия
Критерии включения
- Written informed consent
- Must have successfully completed the preceding phase 3 clinical trials (CDX0159-12 or CDX0159-13).
- Both males and females of child-bearing potential must agree to use highly effective contraceptives when receiving barzolvolimab treatment and for 150 days after treatment.
- Willing and able to comply with all study requirements and procedures, including completion of a daily symptom electronic diary.
Критерии исключения
- Active pruritic skin condition in addition to CSU.
- Medical condition that would cause additional risk or interfere with study procedures.
- Participants without at least one documented UAS7 score from Weeks 64-68 of the CDX0159-12 or CDX0159-13 trials.
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 33 центра
- Cahaba Dermatology & Skin Health Center, LLC — Birmingham
- Medical Research of Arizona — Scottsdale
- Center for Dermatology & Plastic Surgery - Avacare — Scottsdale
- Kern Research — Bakersfield
- Allergy and Asthma Associates of Southern California - Laguna Niguel - CRN — Laguna Niguel
- Dermatology Research Associates — Los Angeles
- LA Universal Research Center, Inc. — Los Angeles
- Encore Medical Research of Boynton Beach LLC — Boynton Beach
- … и ещё 25 центров
Польша · 9 центров
- Centrum Badan Klinicznych PI-House sp. z o.o. — Gdansk
- Synexus Polska Sp. z o.o. Oddzial w Katowicach — Katowice
- Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. — Krakow
- Centrum Medyczne Pratia Poznan — Poznan
- MICS Centrum Medyczne Toruń — Torun
- Klinika Ambroziak Dermatologia — Warsaw
- Ginemedica Sp. z o.o. — Wroclaw
- Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska — Wroclaw
- … и ещё 1 центр
Аргентина · 6 центров
- Conexa Investigación Clínica S.A. — CABA
- Aprillus Asistencia e Investigacion de Arcis Salud SRL — CABA
- Centro Respiratorio Infantil — Rosario
- Instituto de Especialidades de la Salud Rosario - Clínica del Tórax — Rosario
- Instituto Médico de la Fundación Estudios Clínicos — Rosario
- Clinica Mayo de Urgencias — San Miguel de Tucumán
Болгария · 6 центров
- Medical Center Medtech Services EOOD — Haskovo
- Outpatient Clinic for IP for Specialized Outpatient Medical Care in Allergology-Dr.Cholak — Razgrad
- Medical Center Iskar EOOD — Sofia
- Medical Center Hera EOOD — Sofia
- University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov — Sofia
- Medical Center Pulmovision — Sofia
ЮАР · 6 центров
- Worthwhile Clinical Trials — Benoni
- Newtown Clinical Research Centre — Newtown
- Global Clinical Trials (Pty) Ltd - Pretoria — Pretoria
- About Allergy — Pretoria
- Synapta Clinical Research Centre — Durban
- University of Cape Town Lung Institute (UCTLI) — Mowbray
Тайвань · 6 центров
Список центров уточняется — проверьте первичный протокол.
Канада · 5 центров
- VIDA Dermatology — Edmonton
- Lima's Excellence In Allergy And Dermatology Research (Leader) Inc. — Hamilton
- Lynderm Research Inc — Markham
- Evidence Based Medical Educator Inc. — Toronto
- Joel Liem Medicine Professional Corporation — Windsor
Испания · 5 центров
Список центров уточняется — проверьте первичный протокол.
Чили · 3 центра
- Enroll SpA - Dr. Manuel Barros Borgono — Providencia
- Centro Internacional de Estudios Clinicos (CIEC) — Recoleta
- Dermacross Clinica Dermatologica — Vitacura
South Korea · 3 центра
Список центров уточняется — проверьте первичный протокол.
Австралия · 2 центра
- Cornerstone Dermatology — Coorparoo
- The Alfred Hospital - Kern — Melbourne
Франция · 2 центра
- CHRU Nantes Hôtel Dieu — Nantes
- CHU de Nice-Hôpital L'Archet — Nice
Германия · 2 центра
- ProDerma — Dülmen
- Medizinisches Versorgungszentrum DermaKiel GmbH — Kiel
Греция · 2 центра
- University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA — Chaïdári
- Hospital A. Syggros — Athens
Португалия · 2 центра
- ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro — Aveiro
- ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra — Coimbra
Бельгия · 1 центр
- Cliniques Universitaires Saint-Luc — Brussels
Италия · 1 центр
- Azienda Ospedaliera Ordine Mauriziano di Torino — Torino
Таиланд · 1 центр
Список центров уточняется — проверьте первичный протокол.
Великобритания · 1 центр
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07256392 · CDX0159-17