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

• Status: Recruiting
• Trial end date: 2023-02-22
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.