Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome

Summary

This study did evaluate the safety,tolerability and preliminary therapeutic efficacy of multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary Sjögren's syndrome(pSS)

Timeline

Start

2014-10-22

Primary completion

2018-06-29

Completion

2018-06-29

Outcome

Mixed primary results

registry analysis (superiority test); Cohort 1 CFZ533 vs Cohort 1 Placebo; p = 0.397; Mean Difference (Net) -0.41 (95% CI -3.70 to 2.89); NCT02291029 ↗

registry analysis (superiority test); Cohort 2 CFZ533 vs Cohort 2 Placebo; p = 0.009; Mean Difference (Net) -5.21 (95% CI -9.46 to -0.96); NCT02291029 ↗

Publications

• Fisher BA, Szanto A, Ng WF, Bombardieri M, Posch MG, Papas AS, Farag AM, Daikeler T, Bannert B, Kyburz D, Kivitz AJ, Carsons SE, Isenberg DA, Barone F, Bowman SJ, Espie P, Floch D, Dupuy C, Ren X, Faerber PM, Wright AM, Hockey HU, Rotte M, Milojevic J, Avrameas A, Valentin MA, Rush JS, Gergely P. Assessment of the anti-CD40 antibody iscalimab in patients with primary Sjogren's syndrome: a multicentre, randomised, double-blind, placebo-controlled, proof-of-concept study. Lancet Rheumatol. 2020 Mar;2(3):e142-e152. doi: 10.1016/S2665-9913(19)30135-3. Epub 2020 Jan 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	iscalimab	Monoclonal antibody	3 mg/kg	Subcutaneous
Subject	iscalimab	Monoclonal antibody	10 mg/kg	Subcutaneous

Indications