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)
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
This study will evaluate safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome.
Oct 01, 2020
Oct 01, 2019
Jun 21, 2022
18 Years and older (Adult, Older Adult)
liquid placebo for injections
Signed informed consent
Male or female patient ≥ 18 years of age
Classification of Sjögren's Syndrome according to ACR/EULAR 2016 criteria (Shiboski et al 2017)
Seropositive for anti-Ro/SSA antibodies
Stimulated whole salivary flow rate of ≥ 0.1 mL/min
Inclusion criteria specific for Cohort 1:
ESSDAI ≥ 5 within the 8 predefined organ domains
ESSPRI score of ≥5
Inclusion criteria specific for Cohort 2:
ESSDAI < 5 within 8 domains scored for inclusion criterion for Cohort 1
ESSPRI fatigue subscore ≥ 5 or ESSPRI dryness subscore ≥ 5
Sjögren's Syndrome overlap syndromes where another autoimmune rheumatic disease constitutes the principle illness
Use of other investigational drugs
Prior use of B cell depleting therapies, abatacept or any other immunosuppressants unless specifically allowe be the protocol.
Use of steroids at dose >10 mg/day.
Uncontrolled ocular rosacea (affecting the eye adnexa), posterior blepharitis or Meibomian gland disease (this criterion applies only to patients considered for Cohort 2)
Active viral, bacterial or other infections requiring systemic treatment
Receipt of live/attenuated vaccine within a 2-month period prior to randomization.
Chronic infection with hepatitis B (HBV) or hepatitis C (HCV).
Evidence of active tuberculosis (TB) infection.