drugset / Trial / NCT05113004

New Clinical End-points in Patients With Primary Sjögren's Syndrome

NCT05113004

Phase 2 Recruiting 300 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupTriple-blindTreatment

Summary

There are no approved treatments for pSS and the clinical endpoints currently used in clinical trials are inadequate to capture all aspects of the disease that should be evaluated in clinical trials. The newly developed composite endpoint: Sjögren's Tool for Assessing Response to treatment (STAR) will allow a more specific and meaningful assessment of treatment efficacy in pSS. Because of the heterogeneity of the disease and of the central role of the interplay between B- and T-cells in the pathogenesis, it is worth to evaluate combination of conventional synthetic immunomodulatory drugs targeting both B- and T-cells.

Timeline

Start
2022-01-20
Primary completion
2025-04-01
Completion
2025-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydroxychloroquine Small molecule 400 mg
Subject Leflunomide Small molecule 20 mg
Subject Mycophenolate Mofetil Small molecule 2000 mg

Indications