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ACTIVE NOT RECRUITING Phase 3

A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State

NCT06245408 · View on ClinicalTrials.gov ↗

Study Summary

Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS. 2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS 3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Dazodalibep

Study Locations (20)

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

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

Florida

  • Bradenton Research Center Inc — Bradenton
  • Clinical Research of West Florida Inc - Clearwater — Clearwater
  • West Broward Rheumatology Associates, Inc. — Tamarac
  • BayCare Medical Group Primary Care and Rheumatology - Tampa — Tampa

Colorado

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

Kansas

  • University of Kansas Medical Center — Kansas City

Massachusetts

  • Tufts Medical Center - Rheumatology Research Office - PPDS — Boston

Michigan

  • Clinical Research Institute of Michigan, LLC-St. Claire Shores — Saint Clair Shores

Missouri

  • Kansas City Physician Partners-8350 N Saint Clair Ave — Kansas City

Trial Details

FieldValue
Enrollment Target 434 participants
Start Date 2024-04-08
Est. Completion 2026-12-17
Phase Phase 3

Sponsor

Amgen

266 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06245408

The ClinicalTrials.gov registry entry for NCT06245408 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 434 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 Sjögren's Syndrome (SS) 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: NCT06245408 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Arizona, California, Florida. 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 NCT06245408 about?

NCT06245408 is a clinical study titled "A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State". Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS. 2. To evaluate the effect o...

What is the current status of trial NCT06245408?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 434 participants. The study started on 2024-04-08. Estimated completion is 2026-12-17.

What conditions does trial NCT06245408 study?

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

What interventions are being tested in trial NCT06245408?

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 NCT06245408?

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 NCT06245408 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Kansas. 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