CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 69 enrolled
Drug / intervention
CFZ533 active - Cohort 1 +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02291029
NCT02291029Phase 2Completed

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CFZ533 in Patients With Primary Sjögren's Syndrome

Novartis Pharmaceuticals·interventional·Posted Nov 14, 2014·Updated Jan 5, 2021

In Brief

A Phase 2 clinical trial evaluating CFZ533 active - Cohort 1, CFZ533 placebo- Cohort 1, and 4 other interventions for Primary Sjögren's Syndrome. Completed, enrolled 69 participants across 9 sites in 5 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Hungary, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 14, 2014
Enrollment StartOct 22, 2014
Primary CompletionJun 29, 2018
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.6 years ago

Interventions

CFZ533 active - Cohort 1drug

multiple doses of CFZ533 s.c. injection

CFZ533 placebo- Cohort 1drug

multiple doses of placebo s.c. injection

CFZ533 active - Cohort 2drug

multiple doses of CFZ533 intravenous infusion

CFZ533 placebo - Cohort 2drug

multiple doses of placebo intravenous infusion

CFZ533 active -Cohort 3drug

multiple doses of CFZ533 s.c. injection

CFZ533 active - Cohort 3drug

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