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

Phase 3

Recruiting

• Conditions: Sjogren's Syndrome
• Interventions: Drug: Dazodalibep; Drug: Placebo

• Registration Number: NCT06104124
• Lead Sponsor: Amgen

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

Detailed Description

Acquired from Horizon in 2024.

Study Timeline

• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-27
• Study Start: 2024-01-24
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-18
• Primary Completion: 2026-06-02
• Study Completion: 2026-08-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 621

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 hepatitis B, hepatitis C, or HIV infection. A positive test for hepatitis B at screening is defined as: (1) positive for HBsAg OR (2) positive for either HBcAb or HBsAb and HBV DNA detected above the LLOQ by reflex testing by the central laboratory at screening.
• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dazodalibep Dose 1	Dazodalibep	Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.
Dazodalibep Dose 2	Dazodalibep	Participants will be administered dose 2 of dazodalibep by IV infusion.
Placebo	Placebo	Participants will be administered placebo by IV infusion.

Primary Outcome Measures

Name	Time	Method
Change from baseline in European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) Score	At Week 48

Secondary Outcome Measures

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

Trial Locations

Locations (247)

Arizona Arthritis & Rheumatology Associates - Avondale; 🇺🇸 Avondale, Arizona, United States

Arizona Research Clinic PLLC; 🇺🇸 Chandler, Arizona, United States

Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln; 🇺🇸 Flagstaff, Arizona, United States

Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St; 🇺🇸 Gilbert, Arizona, United States

Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln; 🇺🇸 Glendale, Arizona, United States

Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd; 🇺🇸 Tucson, Arizona, United States

UCSD Altman Clinical and Translational Research Institute Building; 🇺🇸 La Jolla, California, United States

Inland Rheumatology Clinical Trials Incorporated; 🇺🇸 Upland, California, United States

Tekton Research, LLC - 2121 E Harmony Rd - PPDS; 🇺🇸 Fort Collins, Colorado, United States

Bradenton Research Center Inc; 🇺🇸 Bradenton, Florida, United States

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