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Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden

NCT07621809 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 570

Last updated 2026-08-18

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.

Conditions

  • Sjögren´s Disease

Interventions

DRUG

VAY736

VAY736 once monthly solution for injection for subcutaneous use.

DRUG

Placebo

Placebo once monthly solution for injection for subcutaneous use.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-16
Primary Completion
2029-08-14
Completion
2033-08-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada

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 NCT07621809 on ClinicalTrials.gov