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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
Date last updated
21/11/2024

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 DASPRI dryness domain score
Timepoint [4] 0 0
At Week 48
Secondary outcome [5] 0 0
Change from baseline in tender and swollen joint counts
Timepoint [5] 0 0
At Week 48
Secondary outcome [6] 0 0
Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue-SF-10a)
Timepoint [6] 0 0
At Week 48
Secondary outcome [7] 0 0
Change from baseline in ESSDAI score
Timepoint [7] 0 0
Week 12 and Week 24
Secondary outcome [8] 0 0
Change from baseline in DASPRI total score
Timepoint [8] 0 0
At Week 48
Secondary outcome [9] 0 0
Change from baseline in ESSPRI total score
Timepoint [9] 0 0
At Week 48
Secondary outcome [10] 0 0
Change from baseline in total stimulated salivary flow
Timepoint [10] 0 0
At Week 48
Secondary outcome [11] 0 0
Number of participants With Treatment Emergent Adverse Events (TEAEs)
Timepoint [11] 0 0
Baseline (Day 1) to Week 56
Secondary outcome [12] 0 0
Number of participants With Treatment Emergent Serious Adverse Events (TESAEs)
Timepoint [12] 0 0
Up to Week 56
Secondary outcome [13] 0 0
Number of participants With Adverse Events of Special Interest (AESIs)
Timepoint [13] 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 hepatitis B, hepatitis C, or HIV infection. A positive test for hepatitis B at screening is defined as: (1) positive for HBsAg OR (2) positive for either HBcAb or HBsAb and HBV DNA detected above the LLOQ by reflex testing by the central laboratory at screening.
* 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
24/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/07/2026
Actual
Sample size
Target
621
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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Grad Zagreb
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Serbia
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Bilbao
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Santa Coloma De Gramenet(Barcelona)
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Sevilla
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Valencia
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Álava
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Taiwan
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Gui Shan Qu
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Kaohsiung City
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Taiwan
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Taichung
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Taipei
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Camden
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Leeds
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London
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United Kingdom
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Portsmouth

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

Ethics approval
Ethics application status

Summary
Brief summary
Primary Objective:

To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe systemic disease activity.

Secondary Objectives:

1. To evaluate the effect of dazodalibep on patient reported outcomes (PROs) in participants with SS.
2. To evaluate the safety and tolerability of dazodalibep in participants with SS
Trial website
https://clinicaltrials.gov/study/NCT06104124
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06104124