A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
Phase 3 – large-scale trial before approval
Conditions:
Sjögren's Syndrome
Sponsor: Amgen
trial.available_in:
БГ
Overview
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
Who can participate
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.
Locations
25
Argentina (1)
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
Ciudad Autónoma de Buenos Aires , Buenos Aires
Australia (1)
The Queen Elizabeth Hospital
Woodville South , South Australia
Belgium (1)
UZ Gent
Ghent
Brazil (1)
SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
Salvador , Estado de Bahia
Canada (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
Croatia (1)
Polyclinic Bonifarm
Zagreb , City of Zagreb
France (1)
CHU de Bordeaux - Hôpital Saint-André
Bordeaux
Germany (1)
University Clinic Heidelberg
Heidelberg , Baden-Wurttemberg
Greece (1)
Naval Hospital of Athens
Athens , Attica
Hungary (1)
Bekes Varmegyei Kozponti Korhaz
Gyula , Bekes County
Israel (1)
Meir Medical Center
Kafr Saba , Central District
Italy (1)
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome , Lazio
Japan (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
Poland (1)
Pratia Poznan - PPDS
Poznan , Greater Poland Voivodeship
Serbia (1)
Military Medical Academy
Belgrade , Belgrade
Slovenia (1)
University Clinical Centre Maribor
Maribor
South Korea (1)
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , Seoul Teugbyeolsi
Spain (1)
Fundacio Hospital de l'Esperit Sant
Santa Coloma de Gramenet , Barcelona
Taiwan (1)
Kaohsiung Medical University - Chung-Ho Memorial Hospital