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ACTIVE NOT RECRUITING Phase 3

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 · View on ClinicalTrials.gov ↗

Study 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

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Dazodalibep

Study Locations (20)

Florida

  • Bradenton Research Center Inc — Bradenton
  • Clinical Research of West Florida Inc - Clearwater — Clearwater
  • University of Miami - Leonard M. Miller School of Medicine — Miami
  • Suncoast Clinical Research - ATLAS - New Port Richey - PPDS — New Port Richey
  • Millennium Research — Ormond Beach
  • West Broward Rheumatology Associates, Inc. — Tamarac
  • BayCare Medical Group — Tampa

Arizona

  • Arizona Arthritis & Rheumatology Associates - Avondale — Avondale
  • Arizona Research Clinic PLLC — Chandler
  • Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln — Flagstaff
  • Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St — Gilbert
  • Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln — Glendale
  • Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd — Tucson

California

  • UCSD Altman Clinical and Translational Research Institute Building — La Jolla
  • Inland Rheumatology Clinical Trials Incorporated — Upland

Colorado

  • Tekton Research, LLC - 2121 E Harmony Rd - PPDS — Fort Collins

Georgia

  • Augusta University Medical Center-Augusta-1120 15th St — Augusta

Illinois

  • OrthoIllinois, LTD — Rockford

Kansas

  • University of Kansas Medical Center — Kansas City

Massachusetts

  • Massachusetts General Hospital — Boston

Trial Details

FieldValue
Enrollment Target 651 participants
Start Date 2024-01-24
Est. Completion 2026-08-19
Phase Phase 3

Sponsor

Amgen

266 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06104124

The ClinicalTrials.gov registry entry for NCT06104124 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 651 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Sjogren's Syndrome appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06104124 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06104124 about?

NCT06104124 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity". 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...

What is the current status of trial NCT06104124?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 651 participants. The study started on 2024-01-24. Estimated completion is 2026-08-19.

What conditions does trial NCT06104124 study?

This clinical trial studies the following conditions: Sjogren's Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06104124?

The interventions under investigation include: Placebo (DRUG), Dazodalibep (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06104124?

This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06104124 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial