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Набира участници Фаза 3 NCT06747949

A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Sjögren's Syndrome

Спонсор: Amgen

Налично на: БГ
Обобщение
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
Кой може да участва
Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: * Participant has provided informed consent before initiation of any study specific activities/procedures. * Must have been eligible to receive and have received IP (dazodalibep or placebo) and completed the study (through Week 48) in one of the phase 3 SS dazodalibep studies (HZNP-DAZ-301, or HZNP-DAZ-303). * Must be able to receive Dose 1 of this LTE study at the Week 48 Visit (+28 days) for the prior pivotal phase 3 SS dazodalibep studies (HZNP DAZ-301, or HZNP DAZ-303). Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Clinically significant active infection at Day 1, in the opinion of the Investigator, including ongoing and chronic infection requiring antibiotics or antiviral medication. * Planned participation in another clinical study with an IP or procedure during the LTE study. Other investigational procedures and participation in observational research studies while participating in this study are excluded. * Any condition or change in health status observed or reported during the phase 3 SS studies (HZNP-DAZ-301, or HZNP-DAZ-303) that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety or alter the risk-benefit associated with IP administration. * Planned surgeries or hospitalizations that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety. * Individuals who plan to receive live (attenuated) vaccine during the LTE study. * Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional 12 weeks after the last dose of investigational product. * Female participants who are pregnant or lactating or planning to become pregnant during the study. * Participant has known sensitivity to any of the products or components to be administered during dosing. * Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge. * History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation.
Места на провеждане 25
Argentina (1)
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
Ciudad Autónoma de Buenos Aires , Buenos Aires
Австралия (1)
The Queen Elizabeth Hospital
Woodville South , South Australia
Белгия (1)
UZ Gent
Ghent
Бразилия (1)
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
Salvador , Estado de Bahia
Канада (1)
Clinique de Rhumatologie Du Centre Du Quebec
Trois-Rivières , Quebec
Chile (1)
Centro de Investigacion de Enfermedades Respiratorias e inmunologicas
Viña del Mar , Valparaiso
Хърватия (1)
Polyclinic Bonifarm
Zagreb , City of Zagreb
Франция (1)
CHU de Bordeaux - Hôpital Saint-André
Bordeaux
Германия (1)
University Clinic Heidelberg
Heidelberg , Baden-Wurttemberg
Гърция (1)
Naval Hospital of Athens
Athens , Attica
Унгария (1)
Bekes Varmegyei Kozponti Korhaz
Gyula , Bekes County
Израел (1)
Meir Medical Center
Kafr Saba , Central District
Италия (1)
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome , Lazio
Япония (1)
Chubu Rosai Hospital
Nagoya-shi , Akita
Mexico (1)
Mediadvance Clinical S.A.P.I. de C.V.
Parques de San Felipe , Chihuahua
New Zealand (1)
Optimal Clinical Trials Ltd - PPDS
Auckland , North Island
Peru (1)
Clinica San Antonio S.A.C
Trujillo , La Libertad
Полша (1)
Pratia Poznan - PPDS
Poznan , Greater Poland Voivodeship
Сърбия (1)
Military Medical Academy
Belgrade , Belgrade
Словения (1)
University Clinical Centre Maribor
Maribor
Южна Корея (1)
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , Seoul Teugbyeolsi
Испания (1)
Fundacio Hospital de l'Esperit Sant
Santa Coloma de Gramenet , Barcelona
Taiwan (1)
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City
Великобритания (1)
Queen Alexandra Hospital
Portsmouth , Hampshire
САЩ (1)
Arizona Arthritis & Rheumatology Associates - Avondale
Avondale , Arizona
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
25.02.2025
Крайна дата
11.12.2029
Регистрационен номер
NCT06747949
Източник
anzctr
Запитване за медицински туризъм

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