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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06104124
Other study ID # HZNP-DAZ-301
Secondary ID 2023-503904-10-0
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 26, 2023
Est. completion date July 28, 2026

Study information

Verified date May 2024
Source Amgen
Contact Amgen Call Center
Phone 866-572-6436
Email medinfo@amgen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Acquired from Horizon in 2024.


Recruitment information / eligibility

Status Recruiting
Enrollment 510
Est. completion date July 28, 2026
Est. primary completion date July 28, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dazodalibep
IV infusion
Placebo
IV infusion

Locations

Country Name City State
Argentina Consultorios Médicos Dr. Doreski - PPDS Ciudad Autónoma de Buenos Aires Buenos Aires
Argentina Instituto de Investigaciones Clinicas Quilmes SRL Quilmes Buenos Aires
Argentina Centro de Investigaciones Médicas Tucumán - PPDS San Miguel De Tucumán Tucumán
Japan Hamamatsu University Hospital Hamamatsu-city Sizuoka
Japan Japan Community Health Care Organization (JCHO) Chukyo Hospital Nagoya-Shi Aiti
Japan Sasebo Chuo Hospital Sasebo-Shi Nagasaki
United States Amarillo Center For Clinical Research - ClinEdge - PPDS Amarillo Texas
United States Accurate Clinical Management - Baytown Baytown Texas
United States Wallace Rheumatic Studies Center, LLC Beverly Hills California
United States Tufts Medical Center - Rheumatology Research Office - PPDS Boston Massachusetts
United States Bradenton Research Center Inc Bradenton Florida
United States Arizona Research Clinic PLLC Chandler Arizona
United States Clinical Research of West Florida Inc - Clearwater Clearwater Florida
United States Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln Flagstaff Arizona
United States Tekton Research, LLC - Fort Collins - PPDS Fort Collins Colorado
United States Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln Glendale Arizona
United States Precision Comprehensive Clinical Research Solutions Grapevine Texas
United States R & H Clinical Research-Katy-777 S Fry Rd Katy Texas
United States Valley Arthritis Center McAllen Texas
United States Shores Rheumatology Saint Clair Shores Michigan
United States West Broward Rheumatology Associates, Inc. Tamarac Florida
United States Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd Tucson Arizona
United States Inland Rheumatology Clinical Trials Incorporated Upland California

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) Score At Week 48
Secondary Proportion of participants achieving ESSDAI response At Week 48
Secondary Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) dryness domain score At Week 48
Secondary Change from baseline in ESSPRI dryness domain score At Week 48
Secondary Change from baseline in tender and swollen joint counts At Week 48
Secondary Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue-SF-10a) At Week 48
Secondary Change from baseline in ESSDAI score Week 12 and Week 24
Secondary Change from baseline in DASPRI total score At Week 48
Secondary Change from baseline in ESSPRI total score At Week 48
Secondary Change from baseline in total stimulated salivary flow At Week 48
Secondary Number of participants With Treatment Emergent Adverse Events (TEAEs) Baseline (Day 1) to Week 56
Secondary Number of participants With Treatment Emergent Serious Adverse Events (TESAEs) Up to Week 56
Secondary Number of participants With Adverse Events of Special Interest (AESIs) Up to Week 56
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