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

a study on Sjögren Syndrome

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

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

Official Title

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

Details

Acquired from Horizon in 2024.

Keywords

Sjogren's Syndrome, Sjögren's Syndrome With Moderate-to-severe Systemic Disease Activity Study Phase: Phase 3, European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI), European Alliance of Associations for Rheumatology Sjögren's Syndrome Patient Reported Index (ESSPRI), European Alliance of Associations for Rheumatology (EULAR), Syndrome, Dazodalibep

Eligibility

You can join if…

Open to people ages 18 years and up

  • Diagnosed with Sjögren's syndrome (SS) by meeting the 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Classification Criteria.
  • Have an European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) score of >= 5 despite symptomatic or local therapy at screening.
  • Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as per the central laboratory test).

You CAN'T join if...

  • Medical history of confirmed deep vein thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
  • Active malignancy or history of malignancy within the last 5 years, except in situ carcinoma of cervix treated with apparent success with curative therapy > 12 months prior to screening OR cutaneous basal cell carcinoma following presumed curative therapy.
  • Individuals with any severe or life-threatening cardiovascular (including vasculitis)

Locations

  • UCSD Altman Clinical and Translational Research Institute Building accepting new patients
    La Jolla California 92037-1337 United States
  • Wallace Rheumatic Studies Center, LLC accepting new patients
    Beverly Hills California 90211-2703 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT06104124
Phase
Phase 3 Sjögren Syndrome Research Study
Study Type
Interventional
Participants
Expecting 621 study participants
Last Updated