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)
Novartis Pharmaceuticals
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.
Description
This is a double-blind, randomized, placebo-controlled multicenter 2-arm Phase III study, evaluating 300 mg ianalumab s.c. against placebo s.c. in adult participants with Sjögren's disease with high symptom burden.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female participants ≥ 18 years of age or as per country-specific legal adult age, whichever is higher * Classification of Sjögren's disease according to ACR/EULAR 2016 criteria. * Seropositive for anti-Ro/SSA antibodies at screening * SSSD oral dryness score ≥ 5 and overall SSSD summary score ≥5 collected over 14 consecutive days during the Screening 2 period * Screening ESSDAI biologic and/or hematologic domain \> 0 Note: laboratory abnormalities for scoring must be confirmed as associated with Sjögren's disease and not be due to other underlying conditions. * S…
Interventions
- DrugVAY736
VAY736 once monthly solution for injection for subcutaneous use.
- DrugPlacebo
Placebo once monthly solution for injection for subcutaneous use.
Locations (2)
- On Site Clinical Solutions LlcCharlotte, North Carolina
- Accurate Clinical ResearchLeague City, Texas