Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease

PHASE2RecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

July 2, 2024

Primary Completion Date

August 29, 2025

Study Completion Date

March 16, 2029

Conditions
Sjögrens DiseaseSystemic Lupus ErythematosusRheumatoid Arthritis
Interventions
BIOLOGICAL

VAY736 1ml PFS

Solution for injection.

BIOLOGICAL

VAY736 2 ml PFS

Solution for injection

BIOLOGICAL

VAY736 2ml AI

Solution for injection.

Trial Locations (37)

1027

RECRUITING

Novartis Investigative Site, Budapest

1036

RECRUITING

Novartis Investigative Site, Budapest

1646

ACTIVE_NOT_RECRUITING

Novartis Investigative Site, Buenos Aires

1878

RECRUITING

Novartis Investigative Site, Quilmes

4000

ACTIVE_NOT_RECRUITING

Novartis Investigative Site, San Miguel de Tucumán

4032

RECRUITING

Novartis Investigative Site, Debrecen

15006

RECRUITING

Novartis Investigative Site, A Coruña

15706

RECRUITING

Novartis Investigative Site, Santiago de Compostela

16635

RECRUITING

Altoona Center for Clin Res, Duncansville

28034

RECRUITING

Novartis Investigative Site, Madrid

30044

COMPLETED

Parris and Associates Rheumatology, Lawrenceville

32789

RECRUITING

Conquest Research, Winter Park

36207

RECRUITING

Pinnacle Research Group Llc, Anniston

38119

ACTIVE_NOT_RECRUITING

Shelby Research LLC, Memphis

38305

RECRUITING

West Tennessee Research Institute, Jackson

44130

RECRUITING

Paramount Med Rsrch and Consult LLC, Middleburg Heights

46202

RECRUITING

Indiana Univ School of Dentistry, Indianapolis

48439

RECRUITING

Ahmed Arif Medical Research Center, Grand Blanc

63800

ACTIVE_NOT_RECRUITING

Novartis Investigative Site, Brno

70809

RECRUITING

Ochsner Health System, Baton Rouge

73116

RECRUITING

RAO Research LLS, Oklahoma City

75150

ACTIVE_NOT_RECRUITING

Southwest Rheum Rsrch LLC, Mesquite

77382

ACTIVE_NOT_RECRUITING

Advanced Rheumatology of Houston, Spring

77401

RECRUITING

Novel Research LLC, Bellaire

78229

RECRUITING

Uni of Texas Health Science Center, San Antonio

84100

RECRUITING

Novartis Investigative Site, Salerno

90623

ACTIVE_NOT_RECRUITING

Advanced Medical Research, La Palma

92835

ACTIVE_NOT_RECRUITING

Providence Medical Foundation, Fullerton

C1055AAF

RECRUITING

Novartis Investigative Site, Ciudad Autonoma de Bs As

L8N 3Z5

RECRUITING

Novartis Investigative Site, Hamilton

M5T 2S8

RECRUITING

Novartis Investigative Site, Toronto

G5L 5T1

ACTIVE_NOT_RECRUITING

Novartis Investigative Site, Rimouski

G9A 3Y2

ACTIVE_NOT_RECRUITING

Novartis Investigative Site, Trois-Rivières

128 50

ACTIVE_NOT_RECRUITING

Novartis Investigative Site, Prague

686 01

ACTIVE_NOT_RECRUITING

Novartis Investigative Site, Uherské Hradiště

30 002

RECRUITING

Novartis Investigative Site, Krakow

20-607

RECRUITING

Novartis Investigative Site, Lublin

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY