Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Sjögren's Syndrome (SS), sponsored by Amgen.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 434 participants |
| Start Date | 2024-04-08 |
| Est. Completion | 2026-12-17 |
| Phase | Phase 3 |
What the registry record for NCT06245408 still lists
NCT06245408 is an interventional study that assigns participants to a tested intervention. The registered 434 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06245408's enrollment target sits among peer trials
434 876th of 2000 higher than 1,125 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04743245 · 434 participants · NA
Delivery SSO2 Therapy for 60 Min in Anterior MI Patients With PCI ≤ 6 Hours of Symptoms Onset Compared to Standard.
- NCT06471920 · 434 participants · NA
Improving Health for Patients With Chronic LBP in Rural Communities Through Telerehabilitation
- NCT07094113 · 434 participants · Phase 1
AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
- NCT05563220 · 435 participants · Phase 1
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI