Recruiting NCT06747949
A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dazodalibep.
- Who it may be relevant to
- Registry conditions: Sjögren's Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Belgium, Brazil +21
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open-Label, Long-term, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants With Sjögren's Syndrome (SS)
Overview
The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
Interventions
- Drug Dazodalibep
Dazodalibep will be given intravenously (IV).
Primary outcome measures
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to 152 weeks]
Secondary outcome measures (2)
- Number of Participants with Anti-drug Antibodies (ADAs) During the Study [Time frame: Up to 132 weeks]
- Plasma Concentration of Dazodalibep [Time frame: Up to 132 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 31 centers
- Arizona Arthritis & Rheumatology Associates - Avondale — Avondale
- Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln — Flagstaff
- Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St — Gilbert
- Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln — Glendale
- Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd — Tucson
- Samy Metyas MD Inc — Covina
- UCSD Altman Clinical and Translational Research Institute Building — La Jolla
- Tekton Research, LLC - 2121 E Harmony Rd - PPDS — Fort Collins
- … and 23 more centers
Poland · 26 centers
Center list to be confirmed — check the primary protocol.
Japan · 21 centers
Center list to be confirmed — check the primary protocol.
Argentina · 15 centers
- Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS — Ciudad Autónoma de Buenos Aires
- Instituto CER S.A. — Quilmes
- Instituto de Investigaciones Clinicas Quilmes SRL — Quilmes
- MR Medicina Reumatologica — San Fernando
- DOM Centro de Reumatología — Buenos Aires
- Centro de Investigaciones Reumatológicas — San Miguel de Tucumán
- Centro Medico Privado de Reumatologia - PPDS — San Miguel de Tucumán
- Clínica Mayo de U.M.C.B. S.R.L — San Miguel de Tucumán
- … and 7 more centers
Italy · 8 centers
- Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Miser — Udine
- Fondazione Policlinico Universitario A Gemelli - Rome - PPDS — Rome
- … and 6 more centers
Mexico · 8 centers
Center list to be confirmed — check the primary protocol.
Spain · 7 centers
Center list to be confirmed — check the primary protocol.
Serbia · 6 centers
Center list to be confirmed — check the primary protocol.
Chile · 5 centers
- Centro de Investigacion de Enfermedades Respiratorias e inmunologicas — Viña del Mar
- Enroll SpA - Dr. Manuel Barros Borgono - PPDS — Providencia
- BIOCINETIC Ltda — Santiago
- Centro de especialidades médicas Vanguardia — Temuco
- Clinical Research Chile SpA - PPDS — Valdivia
France · 5 centers
- CHU de Bordeaux - Hôpital Saint-André — Bordeaux
- CHU de Brest - Hôpital La Cavale Blanche — Brest
- GHRMSA - Hôpital Emile Muller — Mulhouse
- AP-HP - Hôpital Saint Antoine — Paris
- Hôpitaux Universitaires de Strasbourg — Strasbourg
Germany · 4 centers
- University Clinic Heidelberg — Heidelberg
- Rheumazentrum Prof. Dr. med. Gunther Neeck-Standort Bad Doberan — Bad Doberan
- Rheumazentrum Greifswald — Greifswald Hansestadt
- MVZ Rheuma — Hamburg
Greece · 4 centers
- Naval Hospital of Athens — Athens
- Laiko General Hospital of Athens — Athens
- University General Hospital of Larissa — Larissa
- Euromedica Kianous Stavros — Thessaloniki
Hungary · 4 centers
- Bekes Varmegyei Kozponti Korhaz — Gyula
- Vasarhelyi Sarkanyfu Kft. — Hódmezovásárhely
- Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus — Debrecen
- Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián ú — Budapest
Peru · 4 centers
Center list to be confirmed — check the primary protocol.
Portugal · 4 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 4 centers
Center list to be confirmed — check the primary protocol.
Brazil · 3 centers
- SER - Serviços Especializados em Reumatologia da Bahia S/S - ME — Salvador
- Centro de Estudos em Terapias Inovadoras — Curitiba
- LMK Servicos Medicos SS — Porto Alegre
New Zealand · 3 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 3 centers
Center list to be confirmed — check the primary protocol.
Croatia · 2 centers
- Polyclinic Bonifarm — Zagreb
- University Hospital of Split — Split
Israel · 2 centers
- Meir Medical Center — Kafr Saba
- The Chaim Sheba Medical Center - PPDS — Ramat Gan
Australia · 1 center
- The Queen Elizabeth Hospital — Woodville South
Belgium · 1 center
- UZ Gent — Ghent
Canada · 1 center
- Clinique de Rhumatologie Du Centre Du Quebec — Trois-Rivières
Slovenia · 1 center
Center list to be confirmed — check the primary protocol.
South Korea · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06747949 · HZNP-DAZ-304 · 20230050 · 2024-517513-32-00