A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)

Summary

The purpose of this study is to assess the efficacy and safety of human FcRn blocking therapy with efgartigimod compared to placebo, in participants with pSS.

Timeline

Start

2023-04-04

Primary completion

2024-01-29

Completion

2024-02-12

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper No formal statistical hypothesis was tested. PMID 41997805 ↗

Publications

• Peene I, Verstappen GM, Arends S, Kroese FGM, De Boeck K, Achten H, Papadopoulou D, Jacobs J, Bowen E, Teperov E, Meyvisch P, Fardipour P, Kelly A, Brahmbhatt J, Elewaut D, Bootsma H. Efgartigimod in Sjogren's disease: a phase 2, randomised, placebo-controlled, parallel-group, double-blinded, proof-of-concept study (RHO). Ann Rheum Dis. 2026 Jul;85(7):1341-1350. doi: 10.1016/j.ard.2026.03.019. Epub 2026 Apr 16.

Drugs

Indications