Ireland
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Latest
Clinical Trials in the EU / 2025-522271-29-00
Authorised, not yet recruiting Phase III

A randomized, double-blind, placebo-controlled, 2-arm multicenter Phase III study to assess the efficacy and safety of ianalumab in participants with Sjogren's disease with high symptom burden (THALASSA)

2025-522271-29-00 · tracked via the Priya Life Science EU tracker
Sponsor type
Pharmaceutical company
Therapeutic area
Immune System Diseases
Decision date
05/10/2026
Enrollment target
67
Sites
Slovakia, France, Netherlands

Condition studied

Sjögren's disease

Investigational medicinal product(s)

TENOFOVIR DISOPROXILVAY736Placebo to VAY736TENOFOVIR ALAFENAMIDE-ENTECAVIR

Every trial of Tenofovir Alafenamide, Entecavir and Ianalumab across our registers →

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

Change from baseline in SSSD oral dryness score at Week 52

Endpoint detail

Change from baseline in SSSD summary score at Week 52, Change from baseline in ESSPRI score at Week 52, Change from baseline in sSF at Week 52, Change from baseline in PaGA NRS score at Week 52, Achieving SSSD response at week 52, Achieving ESSPRI response at week 52, Change from baseline in SSSD eye dryness score at Week 52., Change from baseline in FACIT- Fatigue score at Week 52, Change from baseline in SRQoL score at Week 52, Incidence of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) •Routine hematology and clinical chemistry laboratory test results • Vital signs

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-522271-29-00 on CTIS ↗ ← All trials in the EU