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

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

Sponsoren

Hauptsponsor: Novartis Pharmaceuticals

Quelle Novartis
Kurze Zusammenfassung

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)

Gesamtstatus Completed
Anfangsdatum October 22, 2014
Fertigstellungstermin June 29, 2018
Primäres Abschlussdatum June 29, 2018
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Baseline and Week 12
Sekundäres Ergebnis
Messen Zeitfenster
Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI) Baseline and Week 12
Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (VAS) Baseline and Week 12
Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS) Baseline and Week 12
Change From Baseline in Short Form (36) Health Survey (SF-36) Physical Component Score Baseline and Week 12
Change From Baseline in Short Form (36) Health Survey (SF-36) Mental Component Score Baseline and Week 12
Change From Baseline in Multidimensional Fatigue Inventory (MFI) Baseline and Week 12
Einschreibung 69
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: CFZ533 active - Cohort 1

Beschreibung: multiple doses of CFZ533 s.c. injection

Armgruppenetikett: CFZ533 active - Cohort 1

Interventionsart: Drug

Interventionsname: CFZ533 placebo- Cohort 1

Beschreibung: multiple doses of placebo s.c. injection

Armgruppenetikett: CFZ533 placebo - Cohort 1

Interventionsart: Drug

Interventionsname: CFZ533 active - Cohort 2

Beschreibung: multiple doses of CFZ533 intravenous infusion

Armgruppenetikett: CFZ533 active- Cohort 2

Interventionsart: Drug

Interventionsname: CFZ533 placebo - Cohort 2

Beschreibung: multiple doses of placebo intravenous infusion

Armgruppenetikett: CFZ533 placebo- Cohort 2

Interventionsart: Drug

Interventionsname: CFZ533 active -Cohort 3

Beschreibung: multiple doses of CFZ533 s.c. injection

Armgruppenetikett: CFZ533 Treatment Arm 1 - Cohort 3

Interventionsart: Drug

Interventionsname: CFZ533 active - Cohort 3

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

Armgruppenetikett: CFZ533 Treatment Arm 2 - Cohort 3

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Diagnosis of primary Sjögren's syndrome

- ESSDAI score ≥ 6

Exclusion Criteria:

- Secondary Sjögren's syndrome

- Receiving cyclosphosphamide, corticosteroid bolus with dose over 1 mg/kg, rituximab, belimunab, other immunosuppressives.

- At significant risk for thromboembolic event

- Clinically significant systemic infection

- Significant elevated risk for infection

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 75 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Ort
Einrichtung:
Novartis Investigative Site | Boston, Massachusetts, 02111, United States
Novartis Investigative Site | Mineola, New York, 11501, United States
Novartis Investigative Site | Duncansville, Pennsylvania, 16635, United States
Novartis Investigative Site | Berlin, 10117, Germany
Novartis Investigative Site | Debrecen, 4032, Hungary
Novartis Investigative Site | Basel, 4031, Switzerland
Novartis Investigative Site | Edgbaston, Birmingham, B15 2WB, United Kingdom
Novartis Investigative Site | London, EC14 7BE, United Kingdom
Novartis Investigative Site | Newcastle upon Tyne, NE2 4HH, United Kingdom
Standort Länder

Germany

Hungary

Switzerland

United Kingdom

United States

Überprüfungsdatum

July 2019

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 6
Armgruppe

Etikette: CFZ533 active- Cohort 2

Art: Experimental

Beschreibung: multiple doses of CFZ533 intravenous infusion

Etikette: CFZ533 placebo- Cohort 2

Art: Placebo Comparator

Beschreibung: multiple doses of placebo intravenous infusion

Etikette: CFZ533 active - Cohort 1

Art: Experimental

Beschreibung: multiple doses of CFZ533 s.c. injection

Etikette: CFZ533 placebo - Cohort 1

Art: Placebo Comparator

Beschreibung: multiple doses of placebo s.c. injection

Etikette: CFZ533 Treatment Arm 1 - Cohort 3

Art: Experimental

Beschreibung: multiple doses of CFZ533 s.c. injection

Etikette: CFZ533 Treatment Arm 2 - Cohort 3

Art: Experimental

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

Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Triple (Participant, Care Provider, Investigator)

Quelle: ClinicalTrials.gov