Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06747949




Registration number
NCT06747949
Ethics application status
Date submitted
19/12/2024
Date registered
24/12/2024
Date last updated
14/07/2025

Titles & IDs
Public title
A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)
Scientific title
A Multicenter, Long-term, Randomized, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants With SS
Secondary ID [1] 0 0
20230050
Secondary ID [2] 0 0
HZNP-DAZ-304
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sjögren'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

Experimental: Dazodalibep/Dazodalibep - Participants who completed the 48-week dazodalibep treatment in trials HZNP-DAZ-301 or HZNP-DAZ-303 will continue with their assigned dose (1 or 2) for an additional 144 weeks.

Experimental: Placebo/Dazodalibep - Participants who completed the 48-week placebo treatment in trials HZNP-DAZ-301 or HZNP-DAZ-303 will be randomized 1:1 to dazodalibep (dose 1 or 2) for an additional 144 weeks.


Treatment: Drugs: Dazodalibep
Dazodalibep will be given intravenously (IV).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to 152 weeks
Secondary outcome [1] 0 0
Number of Participants with Anti-drug Antibodies (ADAs) During the Study
Timepoint [1] 0 0
Up to 152 weeks
Secondary outcome [2] 0 0
Plasma Concentration of Dazodalibep
Timepoint [2] 0 0
Up to 152 weeks

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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, including laboratory studies performed on Week 44 of prior phase 3 study.
* 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.
* Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 12 weeks after the last dose of investigational product.
* Male participants with a pregnant partner 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

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 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
25/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/08/2029
Actual
Sample size
Target
844
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Ciudad Autónoma De BuenosAires
Country [11] 0 0
Argentina
State/province [11] 0 0
San Miguel de Tucumán
Country [12] 0 0
Germany
State/province [12] 0 0
Hamburg
Country [13] 0 0
Israel
State/province [13] 0 0
HaMerkaz
Country [14] 0 0
Japan
State/province [14] 0 0
Hukuoka
Country [15] 0 0
Japan
State/province [15] 0 0
Okayama
Country [16] 0 0
Japan
State/province [16] 0 0
Sizuoka
Country [17] 0 0
Japan
State/province [17] 0 0
Tokyo
Country [18] 0 0
New Zealand
State/province [18] 0 0
Papatoetoe
Country [19] 0 0
Poland
State/province [19] 0 0
Lubelskie
Country [20] 0 0
Poland
State/province [20] 0 0
Pomorskie
Country [21] 0 0
Poland
State/province [21] 0 0
Bydgoszcz
Country [22] 0 0
Poland
State/province [22] 0 0
Lodz
Country [23] 0 0
Poland
State/province [23] 0 0
Warszawa
Country [24] 0 0
Poland
State/province [24] 0 0
Wroclaw
Country [25] 0 0
Portugal
State/province [25] 0 0
Ponte de Lima

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
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06747949