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A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity

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ClinicalTrials.gov Identifier: NCT06104124
Recruitment Status : Recruiting
First Posted : October 27, 2023
Last Update Posted : April 29, 2024
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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

Condition or disease Intervention/treatment Phase
Sjogren's Syndrome Drug: Dazodalibep Drug: Placebo Phase 3

Detailed Description:
Acquired from Horizon in 2024.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 26, 2023
Estimated Primary Completion Date : February 13, 2026
Estimated Study Completion Date : May 8, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dazodalibep Dose 1
Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.
 Drug: Dazodalibep
IV infusion
Other Names:
  • VIB 4920
  • MEDI 4920
Experimental: Dazodalibep Dose 2
Participants will be administered dose 2 of dazodalibep by IV infusion.
 Drug: Dazodalibep
IV infusion
Other Names:
  • VIB 4920
  • MEDI 4920
Placebo Comparator: Placebo
Participants will be administered placebo by IV infusion.
 Drug: Placebo
IV infusion


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) Score [ Time Frame: At Week 48 ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06104124


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT06104124    
Other Study ID Numbers: HZNP-DAZ-301
2023-503904-10-00 ( Registry Identifier: EU Clinical Trial Information System )
First Posted: October 27, 2023    Key Record Dates
Last Update Posted: April 29, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: 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.
URL: http://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Sjögren's Syndrome With Moderate-to-severe Systemic Disease Activity Study Phase: Phase 3
European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI)
European Alliance of Associations for Rheumatology Sjögren's Syndrome Patient Reported Index (ESSPRI)
European Alliance of Associations for Rheumatology (EULAR)
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
 Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases