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

Sjogren's Syndrome Clinical Trial

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome

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

External Links

•   AmgenTrials clinical trials website