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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06104124




Registration number
NCT06104124
Ethics application status
Date submitted
23/10/2023
Date registered
27/10/2023

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity
Scientific title
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome With Moderate-to-severe Systemic Disease Activity
Secondary ID [1] 0 0
2023-503904-10-00
Secondary ID [2] 0 0
HZNP-DAZ-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sjogren's Syndrome 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dazodalibep
Treatment: Drugs - Placebo

Experimental: Dazodalibep Dose 1 - Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.

Experimental: Dazodalibep Dose 2 - Participants will be administered dose 2 of dazodalibep by IV infusion.

Placebo comparator: Placebo - Participants will be administered placebo by IV infusion.


Treatment: Drugs: Dazodalibep
IV infusion

Treatment: Drugs: Placebo
IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) Score
Timepoint [1] 0 0
At Week 48
Secondary outcome [1] 0 0
Proportion of participants achieving ESSDAI response
Timepoint [1] 0 0
At Week 48
Secondary outcome [2] 0 0
Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) dryness domain score
Timepoint [2] 0 0
At Week 48
Secondary outcome [3] 0 0
Change from baseline in ESSPRI dryness domain score
Timepoint [3] 0 0
At Week 48
Secondary outcome [4] 0 0
Change from baseline in tender and swollen joint counts
Timepoint [4] 0 0
At Week 48
Secondary outcome [5] 0 0
Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue-SF-10a)
Timepoint [5] 0 0
At Week 48
Secondary outcome [6] 0 0
Change from baseline in ESSDAI score
Timepoint [6] 0 0
Week 12 and Week 24
Secondary outcome [7] 0 0
Change from baseline in DASPRI total score
Timepoint [7] 0 0
At Week 48
Secondary outcome [8] 0 0
Change from baseline in ESSPRI total score
Timepoint [8] 0 0
At Week 48
Secondary outcome [9] 0 0
Change from baseline in total stimulated salivary flow
Timepoint [9] 0 0
At Week 48
Secondary outcome [10] 0 0
Number of participants With Treatment Emergent Adverse Events (TEAEs)
Timepoint [10] 0 0
Baseline (Day 1) to Week 56
Secondary outcome [11] 0 0
Number of participants With Treatment Emergent Serious Adverse Events (TESAEs)
Timepoint [11] 0 0
Up to Week 56
Secondary outcome [12] 0 0
Number of participants With Adverse Events of Special Interest (AESIs)
Timepoint [12] 0 0
Up to Week 56

Eligibility
Key inclusion criteria
Key

* Diagnosed with Sjögren's syndrome (SS) by meeting the 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Classification Criteria.
* Have an European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) score of >= 5 despite symptomatic or local therapy at screening.
* Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as per the central laboratory test).

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Medical history of confirmed deep vein thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
* Active malignancy or history of malignancy within the last 5 years, except in situ carcinoma of cervix treated with apparent success with curative therapy > 12 months prior to screening OR cutaneous basal cell carcinoma following presumed curative therapy.
* Individuals with any severe or life-threatening cardiovascular (including vasculitis), respiratory, endocrine, gastrointestinal, hematological, psychiatric, or systemic disorder or any other condition that would place the individual at unacceptable risk of complications, interfere with evaluation of the IP, or confound the interpretation of participant safety or study results.
* Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis C (unless they have undergone hepatitis C antiviral treatment and have undetectable viral level of hepatitis C RNA at least 24 weeks following completion of therapy) or human immunodeficiency virus (HIV) infection.
* Active TB or untreated (per local guidelines) latent TB
* Individuals with a history of more than one episode of herpes zoster and/or any opportunistic infection in the last 12 months, and active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring intravenous (IV) antibiotics within 12 months prior to screening.
* Individuals who have received a live (attenuated) vaccine within the 4 weeks prior to randomization or plan to receive a live vaccine during their participation in the study.
* Last administration of experimental or investigational biologic or oral agents < 6 months prior to screening.
* Individuals who have had previous treatment with any biologic B-cell-depleting therapy (eg, rituximab, ocrelizumab, inebilizumab, ofatumumab, or ianalumab) within 12 months or other B-cell-targeting therapy (eg, belimumab) < 3 months prior to screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/07/2026
Actual
Sample size
Target
510
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment postcode(s) [1] 0 0
5011 - Woodville South
Recruitment outside Australia
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United States of America
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Los Ríos
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Valparaíso
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Grad Zagreb
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Serbia
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Bilbao
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Álava
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Gui Shan Qu
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Taichung
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Taipei
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Leeds
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
medinfo@amgen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06104124