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MOSAIC Study of methotrexate versus hydroxychloroquine in primary Sjögren’s disease

2026-526767-38-00Phase 2Authorised

Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
Start: Oct 2026
Modality: Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules, Nucleic Acid-Directed Small Molecules → Small Molecules
Countries: 1

Overview

Phase 2, randomised, open-label trial in Sjögren's syndrome comparing Methotrexate arm with Hydroxychloroquine arm (2 arms). Primary endpoint: Change from baseline in ESSDAI score at Week 74. Planned start Oct 2026; status: authorised.

Drugs

methotrexatehydroxychloroquine

Conditions

Sjögren's syndrome

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