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

Description

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

Conditions

Sjogren's Syndrome

Study Overview

Study Details

Study overview

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

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

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

Condition
Sjogren's Syndrome
Intervention / Treatment

-

Contacts and Locations

Chandler

Arizona Research Clinic PLLC, Chandler, Arizona, United States, 85225-2915

Flagstaff

Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln, Flagstaff, Arizona, United States, 86001-6299

Gilbert

Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St, Gilbert, Arizona, United States, 85297-7338

Glendale

Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln, Glendale, Arizona, United States, 85306-9800

Tucson

Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd, Tucson, Arizona, United States, 85704-1140

Beverly Hills

Wallace Rheumatic Studies Center, LLC, Beverly Hills, California, United States, 90211-2703

La Jolla

UCSD Altman Clinical and Translational Research Institute Building, La Jolla, California, United States, 92037-1337

Upland

Inland Rheumatology Clinical Trials Incorporated, Upland, California, United States, 91786-4951

Fort Collins

Tekton Research, LLC - 2121 E Harmony Rd - PPDS, Fort Collins, Colorado, United States, 80528-3404

Bradenton

Bradenton Research Center Inc, Bradenton, Florida, United States, 34205-1704

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2026-07-28