Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CDZ173 in Patients With Primary Sjögren's Syndrome

Sponsoren

Hauptsponsor: Novartis Pharmaceuticals

Quelle Novartis
Kurze Zusammenfassung

This Study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary therapeutic efficacy of oral administrations of CDZ173 in patients with primary Sjögren's syndrome.

detaillierte Beschreibung

This study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary therapeutic efficacy of oral administrations of CDZ173, a selective PI3K delta inhibitor, for 12 weeks, in patients with primary Sjögren's syndrome. Data from this study will provide the basis for further development of the compound for the treatment of primary Sjögren's syndrome.

Gesamtstatus Completed
Anfangsdatum June 1, 2016
Fertigstellungstermin May 17, 2017
Primäres Abschlussdatum May 17, 2017
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85 up to Day 85
Change From Baseline in the EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI) After 12 Weeks of Treatment Day 85 Baseline and 12 weeks (Day 85)
Sekundäres Ergebnis
Messen Zeitfenster
Change From Baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) After 12 Weeks of Treatment Day 85 Baseline and 12 weeks (Day 85)
Change From Baseline in the Short Form (36) Health Survey (SF-36) After 12 Weeks of Treatment Day 85 Baseline and 12 weeks (Day 85)
Change in Baseline in Multidimensional Fatigue Inventory (MFI) After 12 Weeks of Treatment (Day 85) Baseline and 12 weeks (Day 85)
Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (Physician VAS) After 12 Weeks of Treatment Day 85 Baseline and 12 weeks (Day 85)
Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS) After 12 Weeks of Treatment Day 85 Baseline and 12 weeks
Einschreibung 30
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: CDZ173

Armgruppenetikett: CDZ173

Interventionsart: Drug

Interventionsname: Placebo

Armgruppenetikett: Placebo

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Diagnosis of primary Sjögren's syndrome (pSS)

- ESSDAI score ≥ 6 at screening visit

Exclusion Criteria:

- Secondary Sjögren's syndrome

Other protocol-defined inclusion/exclusion criteria may apply.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 75 Years

Gesunde Freiwillige: No

Ort
Einrichtung:
Novartis Investigative Site | Berlin, 10117, Germany
Novartis Investigative Site | Debrecen, 4032, Hungary
Standort Länder

Germany

Hungary

Überprüfungsdatum

September 2019

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: CDZ173

Art: Experimental

Beschreibung: Capsule

Etikette: Placebo

Art: Placebo Comparator

Beschreibung: Capsule matching Placebo

Patientendaten No
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Double (Participant, Investigator)

Quelle: ClinicalTrials.gov