Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome

Phase 1

• Conditions: Sjögren syndrome; MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-004476-35-GB
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-06
• Last Update Posted: 30 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 260

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

Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 221
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 39

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.

Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified