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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06245408




Registration number
NCT06245408
Ethics application status
Date submitted
30/01/2024
Date registered
7/02/2024

Titles & IDs
Public title
A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State
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 Symptom State (HZNP-DAZ-303)
Secondary ID [1] 0 0
HZNP-DAZ-303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sjögren's Syndrome (SS) 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 ESSPRI score
Timepoint [1] 0 0
At Week 48
Primary outcome [2] 0 0
Change from baseline in Diary for Assessing Sjogren's Patient Reported Index (DASPRI ) score
Timepoint [2] 0 0
At week 48
Secondary outcome [1] 0 0
Proportion of participants achieving meaningful improvement in DASPRI
Timepoint [1] 0 0
At Week 48
Secondary outcome [2] 0 0
Proportion of participants achieving ESSPRI [1.5] response
Timepoint [2] 0 0
At Week 48
Secondary outcome [3] 0 0
Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue SF-10a)
Timepoint [3] 0 0
At Week 48
Secondary outcome [4] 0 0
Change from baseline in DASPRI Dryness
Timepoint [4] 0 0
At Week 48
Secondary outcome [5] 0 0
Change from baseline in ESSPRI Dryness
Timepoint [5] 0 0
At Week 48
Secondary outcome [6] 0 0
Change from baseline in DASPRI Pain
Timepoint [6] 0 0
At Week 48
Secondary outcome [7] 0 0
Change from baseline in ESSPRI Pain
Timepoint [7] 0 0
At Week 48
Secondary outcome [8] 0 0
Change from baseline in 36-item Short Form Survey (SF-36) Physical Component Summary (PCS) score
Timepoint [8] 0 0
At Week 48
Secondary outcome [9] 0 0
Change from baseline in DASPRI total score
Timepoint [9] 0 0
At week 12 and week 24
Secondary outcome [10] 0 0
Change from baseline in ESSPRI total score
Timepoint [10] 0 0
At week 12, Week 24
Secondary outcome [11] 0 0
Change from baseline in DASPRI Fatigue
Timepoint [11] 0 0
At Week 48
Secondary outcome [12] 0 0
Change from baseline in ESSPRI fatigue domain score
Timepoint [12] 0 0
At Week 48
Secondary outcome [13] 0 0
Change from baseline in total stimulated salivary flow
Timepoint [13] 0 0
At Week 48
Secondary outcome [14] 0 0
Number of participants With Treatment Emergent Adverse Events (TEAEs)
Timepoint [14] 0 0
Baseline (Day 1) to Week 56
Secondary outcome [15] 0 0
Number of participants With Treatment Emergent Serious Adverse Events (TESAEs)
Timepoint [15] 0 0
Baseline (Day 1) to Week 56
Secondary outcome [16] 0 0
Number of participants With Adverse Events of Special Interest (AESIs)
Timepoint [16] 0 0
Baseline (Day 1) to Week 56

Eligibility
Key inclusion criteria
Key

1. Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria
2. Have an ESSPRI score of = 5 at screening.
3. Have an ESSDAI score of < 5 at screening.
4. Positive for either anti-Ro autoantibodies or RF, or both at screening (as per the definition of the standard central laboratory test).
5. Residual salivary gland function as defined by whole stimulated salivary flow > 0.1 mL/min.
6. Vaccinated against SARS-CoV-2 according to current local authority guidelines at least 2 weeks prior to screening unless participant refuses vaccination.
7. Meets all of the following tuberculosis (TB) criteria:

1. No history of latent or active TB prior to screening, except for latent TB with documented completion of locally appropriate treatment.
2. No signs or symptoms suggestive of active TB from medical history or physical examination.
3. No recent (= 12 weeks of screening) close contact with a person with active TB (close contact is defined as = 4 hours/week OR living in the same household OR in a house where a person with active TB is a frequent visitor).
4. Negative Interferon Gamma Release Assay (IGRA) test result for TB at screen unless previously treated as per Inclusion Criterion. Participants with an indeterminate test result can repeat the test, but if the repeat test is also indeterminate, they are excluded.
5. A chest radiograph (obtained during the screening period or any time within 12 weeks prior to screening) with no evidence of current active TB or other infection, or prior TB, malignancy, or clinically significant abnormalities suggesting an active process (unless due to SS).

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Individuals with medical history of confirmed deep venous thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
2. History or presence of concomitant polymyositis or dermatomyositis or systemic sclerosis.
3. Active malignancy or history of malignancy within the last 5 years, except as follows:

1. In situ carcinoma of the cervix treated with apparent success with curative therapy > 12 months prior to screening; OR
2. Cutaneous basal cell carcinoma following presumed curative therapy.
4. Individuals who are pregnant or lactating or planning to become pregnant during the study.
5. Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy.
6. Individuals with any severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disorder or any other condition that, in the opinion of the Investigator, 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.
7. Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis c or HIV infection.
8. Individuals with a positive test for SARS-CoV-2 on the day of randomization or symptoms suggestive of SARS-CoV-2 at randomization or significant exposure to coronavirus disease 2019 (COVID-19) within 10 calendar days prior to randomization.
9. Individuals with:

1. A history of more than one episode of herpes zoster and/or opportunistic infections in the last 12 months, with the exception of non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity.
2. Active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring IV antibiotics within 12 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
8/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/08/2026
Actual
Sample size
Target
435
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
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Missouri
Country [8] 0 0
United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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North Carolina
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Ohio
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Texas
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Washington
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United States of America
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West Virginia
Country [15] 0 0
Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma De BuenosAires
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Argentina
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Tucumán
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Argentina
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Ciudad Autónoma de Buenos Aires
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Argentina
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Córdoba
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Argentina
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San Juan
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Belgium
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Gent
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Brazil
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Bahia
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Brazil
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Minas Gerais
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Brazil
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Quebec
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Chile
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Los Ríos
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Chile
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Región-MetropolitanadeSantiago
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Croatia
State/province [29] 0 0
Grad Zagreb
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Croatia
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Split
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Denmark
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South Denmark
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France
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Bordeaux
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France
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Brest
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France
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Mulhouse
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France
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Paris
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France
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Strasbourg
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Germany
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Baden-Württemberg
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Germany
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Mecklenburg-Vorpommern
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Germany
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Chemnitz
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Germany
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Hamburg
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Greece
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Attiki
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Greece
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Larisa
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Greece
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Thessaloniki
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Hungary
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Csongrád
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Hungary
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Hajdú-Bihar
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Hungary
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Budapest
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Italy
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Emilia-Romagna
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Italy
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Friuli-Venezia Giulia
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Italy
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Lazio
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Lombardia
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Piemonte
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Italy
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Toscana
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Veneto
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Catania
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Milano
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Pisa
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Aiti
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Japan
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Hokkaidô
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Hukuoka
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Hyôgo
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Ibaraki
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Isikawa
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Kanagawa
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Kyôto
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Nagasaki
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Okayama
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Japan
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Saitama
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Sizuoka
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Tokyo
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Korea, Republic of
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Gwangju
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Elblag
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Katowice
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Kraków
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Poznan
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Warszawa
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Wroclaw
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Lódz
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Portugal
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Lisboa
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Portugal
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Ponte De Lima
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Portugal
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Vila Nova de Gaia
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Puerto Rico
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San Juan
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Serbia
State/province [98] 0 0
Belgrade
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Serbia
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Kragujevac
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Serbia
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Novi Sad
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Slovenia
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Ljubljana
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Slovenia
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Maribor
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Spain
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Córdoba
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Spain
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Vizcaya
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Spain
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A Coruña
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Spain
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la Laguna
Country [107] 0 0
Spain
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Madrid
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Spain
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Santa Coloma De Gramenet(Barcelona)
Country [109] 0 0
Spain
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Sevilla
Country [110] 0 0
Spain
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Valencia
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Spain
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Álava
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Taiwan
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Kaohsiung
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Taiwan
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Taichung City
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Taiwan
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Taipei
Country [115] 0 0
Taiwan
State/province [115] 0 0
Taoyuan City

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/NCT06245408