Phase 2 study in patients with Sjögren’s Syndrome - TWINSS
Research type
Research Study
Full title
A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS)
IRAS ID
262780
Contact name
Benjamin Fisher
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-004476-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 5 days
Research summary
Research Summary
Sjögren's Syndrome (SjS) is the UK's second most common autoimmune rheumatic disease, yet the condition remains under recognised and frequently under treated. The effects of SjS can be widespread; the moisture-producing glands of the body are affected and many organ systems may be involved as well.
CFZ533 (iscalimab) belongs to a class of compounds called “biologics” (a protein drug manufactured in cells) and specifically is a fully human monoclonal antibody. This means that it is an antibody (protein that helps your body fight outside particles like germs) of a single type (one clone or “monoclonal”) and made to look like human (“fully human”) antibodies. CFZ533 acts by blocking the ability of two proteins in your body, called CD154 and CD40, to link as one. CD154 and CD40 help the immune system function to fight germs but can also cause inflammation and disease. By blocking the linking of these two proteins, CFZ533 will lower the activity of the immune system and may have a positive effect on disease symptoms.
The study aims to find out if CFZ533 is safe and has beneficial effects in people who have SjS. Eligible patients will be randomised to one of two cohorts; cohort 1 patients with moderate to severe SjS, and cohort 2 patients with a low systemic involvement but high symptom burden including fatigue, dryness and eye involvement.
Eligible patients will be randomly allocated to the following:
Cohort 1: Treatment Arm A - 600 mg s.c. (subcutaneous meaning under the skin), Treatment Arm B - 300 mg s.c., Treatment Arm C - 150 mg s.c. (48 weeks) or Treatment Arm D/D1 - placebo s.c. for 24 weeks and witch to CFZ533 600 mg s.c. for 24 weeks.
Cohort 2: Treatment Arm E - 600 mg s.c. (48weeks) or Treatment Arm F/F1 - placebo s.c. for 24 weeks and switch to CFZ533 300 mg s.c. for 24 weeks.A post treatment safety follow up period for all patients will last 12 weeks.
Summary of Results
The English lay summary is already public on NovCTRD
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
19/EE/0287
Date of REC Opinion
7 Jan 2020
REC opinion
Further Information Favourable Opinion