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Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome

NCT02291029 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2021-01-05

Study results available
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Summary

This study did evaluate the safety,tolerability and preliminary therapeutic efficacy of multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary Sjögren's syndrome(pSS)

Conditions

  • Primary Sjögren's Syndrome

Interventions

DRUG

CFZ533 active - Cohort 1

multiple doses of CFZ533 s.c. injection

DRUG

CFZ533 placebo- Cohort 1

multiple doses of placebo s.c. injection

DRUG

CFZ533 active - Cohort 2

multiple doses of CFZ533 intravenous infusion

DRUG

CFZ533 placebo - Cohort 2

multiple doses of placebo intravenous infusion

DRUG

CFZ533 active -Cohort 3

multiple doses of CFZ533 s.c. injection

DRUG

CFZ533 active - Cohort 3

Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-22
Primary Completion
2018-06-29
Completion
2018-06-29

Countries

  • United States
  • Germany
  • Hungary
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02291029 on ClinicalTrials.gov