Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome

Phase 2 Completed 273 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study was to evaluate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome (SjS).

Timeline

Start: 2019-10-01
Primary completion: 2022-09-28
Completion: 2023-06-06

Outcome

Mixed primary results

registry p = 0.0025; LS Mean difference CFZ533-Placebo -3.0 (95% CI -4.9 to -1.1) NCT03905525 ↗

registry p = 0.1578; LS Mean difference CFZ533-Placebo -1.4 (95% CI -3.3 to 0.5) NCT03905525 ↗

registry p = 0.1210; LS Mean difference CFZ533-Placebo -0.57 (95% CI -1.30 to 0.15) NCT03905525 ↗

Publications

Fisher BA, Mariette X, Papas A, Grader-Beck T, Bootsma H, Ng WF, van Daele PLA, Finzel S, Noaiseh G, Elgueta S, Hermann J, McCoy SS, Akpek E, Bookman A, Sopala M, Montecchi-Palmer M, Luo WL, Scheurer C, Hueber W; TWINSS study group. Safety and efficacy of subcutaneous iscalimab (CFZ533) in two distinct populations of patients with Sjogren's disease (TWINSS): week 24 results of a randomised, double-blind, placebo-controlled, phase 2b dose-ranging study. Lancet. 2024 Aug 10;404(10452):540-553. doi: 10.1016/S0140-6736(24)01211-X. Epub 2024 Jul 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	iscalimab	Monoclonal antibody	150 mg	Subcutaneous
Subject	iscalimab	Monoclonal antibody	300 mg	Subcutaneous
Subject	iscalimab	Monoclonal antibody	600 mg	Subcutaneous