A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome

PHASE2TerminatedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

July 12, 2019

Primary Completion Date

November 23, 2021

Study Completion Date

November 23, 2021

Conditions
Sjögren Syndrome
Interventions
DRUG

Remibrutinib

Remibrutinib 100 mg was administered orally as two 50 mg hard gelatin capsules. Patients in the remibrutinib 100 mg bid dose group took 2 capsules of active medication in the morning and 2 capsules of active medication in the evening. Patients in the remibrutinib 100 mg qd dose group took 2 capsules of active medication in the morning and 2 capsules of the placebo in the evening.

DRUG

Placebo

Placebo was administered orally as two hard gelatin capsules. Patients in the placebo dose group took 2 capsules of placebo in the morning and 2 capsules of placebo in the evening.

Trial Locations (26)

1011

Novartis Investigative Site, Lausanne

1612

Novartis Investigative Site, Sofia

2600

Novartis Investigative Site, Glostrup Municipality

3168

Novartis Investigative Site, Clayton

4031

Novartis Investigative Site, Basel

4032

Novartis Investigative Site, Debrecen

5011

Novartis Investigative Site, Woodville

7000

Novartis Investigative Site, Hobart

9000

Novartis Investigative Site, Ghent

10117

Novartis Investigative Site, Berlin

28041

Novartis Investigative Site, Madrid

36200

Novartis Investigative Site, Vigo

40201

Novartis Investigative Site, Taichung

40447

Novartis Investigative Site, Taichung

40705

Novartis Investigative Site, Taichung

46010

Novartis Investigative Site, Valencia

81346

Novartis Investigative Site, Kaohsiung City

210008

Novartis Investigative Site, Nanjing

230001

Novartis Investigative Site, Hefei

610041

Novartis Investigative Site, Chengdu

02111

Novartis Investigative Site, Boston

08208

Novartis Investigative Site, Sabadell

08041

Novartis Investigative Site, Barcelona

L9 7AL

Novartis Investigative Site, Liverpool

SN3 6BB

Novartis Investigative Site, Swindon

NE29 8NH

Novartis Investigative Site, Tyne and Wear

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY