🏛️ Verified NIH Record • Updated 2026-01-14

A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity (NCT06104124)

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

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Amgen

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: Arizona Arthritis & Rheumatology Associates - Avondale — Avondale, Arizona

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (216 Sites)

Showing the first 25 of 216 sites.

  • Arizona Arthritis & Rheumatology Associates - Avondale — Avondale, Arizona
  • Arizona Research Clinic PLLC — Chandler, Arizona
  • Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln — Flagstaff, Arizona
  • Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St — Gilbert, Arizona
  • Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln — Glendale, Arizona
  • Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd — Tucson, Arizona
  • UCSD Altman Clinical and Translational Research Institute Building — La Jolla, California
  • Inland Rheumatology Clinical Trials Incorporated — Upland, California
  • Tekton Research, LLC - 2121 E Harmony Rd - PPDS — Fort Collins, Colorado
  • Bradenton Research Center Inc — Bradenton, Florida
  • Clinical Research of West Florida Inc - Clearwater — Clearwater, Florida
  • University of Miami - Leonard M. Miller School of Medicine — Miami, Florida
  • Suncoast Clinical Research - ATLAS - New Port Richey - PPDS — New Port Richey, Florida
  • Millennium Research — Ormond Beach, Florida
  • West Broward Rheumatology Associates, Inc. — Tamarac, Florida
  • BayCare Medical Group — Tampa, Florida
  • Augusta University Medical Center-Augusta-1120 15th St — Augusta, Georgia
  • OrthoIllinois, LTD — Rockford, Illinois
  • University of Kansas Medical Center — Kansas City, Kansas
  • Massachusetts General Hospital — Boston, Massachusetts
  • Clinical Research Institute of Michigan, LLC-St. Claire Shores — Saint Clair Shores, Michigan
  • Kansas City Physician Partners-8350 N Saint Clair Ave — Kansas City, Missouri
  • Arthritis, Rheumatic & Bone Disease Associates - P — Voorhees Township, New Jersey
  • NYU Langone Health - Joseph S. and Diane H. Steinberg Ambulatory Care Center — Brooklyn, New York
  • Arthritis and Osteoporosis Consultants of The Carolinas - Charlotte - 1918 Randolph Rd — Charlotte, North Carolina

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗