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

NCT06245408 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 434

Last updated 2026-01-08

No results posted yet for this 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

  • Sjögren's Syndrome (SS)

Interventions

DRUG

Dazodalibep

IV infusion

DRUG

Placebo

IV infusion

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-08
Primary Completion
2026-10-22
Completion
2026-12-17
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Croatia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Japan
  • Mexico
  • New Zealand
  • Peru
  • Poland
  • Portugal
  • Puerto Rico
  • Serbia
  • Slovenia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06245408 on ClinicalTrials.gov