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NCT06245408 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Sjögren's Syndrome (SS), sponsored by Amgen.

Active
Registry status
Phase 3
Development phase
434
Enrollment target
20
Study locations

NCT06245408 is a Phase 3 study of Sjögren's Syndrome (SS) that is active but no longer recruiting, run by Amgen. The registered enrollment target is 434 participants. The trial reports 20 study locations across 9 states.

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The verdict

NCT06245408, a Phase 3 study of Sjögren's Syndrome (SS), is active but no longer recruiting, sponsored by Amgen.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
434 participants
Enrollment target
20
Study locations

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

558 total trials

What the Registry Record Tells You About NCT06245408

The ClinicalTrials.gov registry entry for NCT06245408 describes a study currently listed as active not recruiting, categorized as Phase 3. 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 558 total studies on file at ClinicalTrials.gov.

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.

NCT06245408 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Arizona, California, Florida.

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).

What interventions are being tested in trial NCT06245408?

The interventions under investigation include: Placebo (DRUG), Dazodalibep (DRUG).

Who is sponsoring clinical trial NCT06245408?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.