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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
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE). A second cohort will be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.
Official title: A Randomized, Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL Pre-filled Syringe With 1 mL Pre-filled Syringe in Adult Participants With Autoimmune Disease
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
155
Start Date
2024-07-02
Completion Date
2029-01-04
Last Updated
2025-12-04
Healthy Volunteers
No
Interventions
VAY736 1ml PFS
Solution for injection.
VAY736 2 ml PFS
Solution for injection
VAY736 2ml AI
Solution for injection.
Locations (37)
Pinnacle Research Group Llc
Anniston, Alabama, United States
Providence Medical Foundation
Fullerton, California, United States
Advanced Medical Research
La Palma, California, United States
Conquest Research
Winter Park, Florida, United States
Parris and Associates Rheumatology
Lawrenceville, Georgia, United States
Indiana Univ School of Dentistry
Indianapolis, Indiana, United States
Ochsner Health System
Baton Rouge, Louisiana, United States
Ahmed Arif Medical Research Center
Grand Blanc, Michigan, United States
Paramount Med Rsrch and Consult LLC
Middleburg Heights, Ohio, United States
RAO Research LLC
Oklahoma City, Oklahoma, United States
Altoona Center for Clin Res
Duncansville, Pennsylvania, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Shelby Research LLC
Memphis, Tennessee, United States
Novel Research LLC
Bellaire, Texas, United States
Southwest Rheum Rsrch LLC
Mesquite, Texas, United States
Uni of Texas Health Science Center
San Antonio, Texas, United States
Advanced Rheumatology of Houston
Spring, Texas, United States
Novartis Investigative Site
Quilmes, Buenos Aires, Argentina
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, Argentina
Novartis Investigative Site
Buenos Aires, Argentina
Novartis Investigative Site
Buenos Aires, Argentina
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Rimouski, Quebec, Canada
Novartis Investigative Site
Trois-Rivières, Quebec, Canada
Novartis Investigative Site
Brno, Czechia
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Uherské Hradiště, Czechia
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Salerno, SA, Italy
Novartis Investigative Site
Krakow, Poland
Novartis Investigative Site
Lublin, Poland
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain
Novartis Investigative Site
A Coruña, Spain
Novartis Investigative Site
Madrid, Spain