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
Running, not enrolling · Phase 2
Conditions studied: Sjögrens Disease, Systemic Lupus Erythematosus, Rheumatoid Arthritis
In brief
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.
Key facts
- Study ID
- NCT06293365
- Run by
- Novartis Pharmaceuticals
- People needed
- 155
- Starts
- 2024-07-02
- Expected to finish
- 2029-01-16
- Last updated by the study team
- 2026-06-05
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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 Tucuman, 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
Full record on ClinicalTrials.gov
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