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

  • STATUS
    Recruiting
  • End date
    Feb 22, 2023
  • participants needed
    260
  • sponsor
    Novartis Pharmaceuticals
Updated on 22 August 2021
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Summary

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

Description

This is a double-blind, randomized, placebo-controlled, multicenter study of CFZ533 in 2 distinct populations (cohorts) of patients with Sjgren's Syndrome: 1) moderate-to-severe disease (systemic and symptomatic involvement) and; 2) low systemic involvement but high symptom burden.

The study includes up to 6 weeks screning period, 48 weeks of treatment (divided into treatment periods of 24 weeks each) and 12 weeks follow up. Study treament will be administered as bi-weekly subcutaneous injections.

Details
Condition Sicca Syndrome, Sjogren's Syndrome
Treatment Placebo, CFZ533
Clinical Study IdentifierNCT03905525
SponsorNovartis Pharmaceuticals
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed informed consent
Male or female patient 18 years of age
Classification of Sjgren'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

Sjgren'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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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