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Sponsor: Novartis Pharmaceuticals
Conditions: Sjögrens Disease, Systemic Lupus Erythematosus, Rheumatoid Arthritis
Interventions: VAY736 1ml PFS, VAY736 2 ml PFS, VAY736 2ml AI
Countries: United States, Argentina, Canada, Czechia, Hungary, Italy, Poland, Spain
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.
Sex: ALL
Age: 18 Years to 70 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Key Inclusion criteria: * Signed informed consent must be obtained before any assessment is performed. * Male and female patients aged 18 years to 70 years (inclusive). * Body weight at least 35 kg and not more than 150 kg and must have a body mass index (BMI) within the range of 18 - 35 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2 at screening. * Diagnosed with RA, SjD and/or SLE as determined by the investigator. * Have active disease (RA, SjD or SLE) that may benefit from B-cell depletion therapy, as determined by the investigator. * Participants currently receiving protocol-allowed SoC should be on stable doses of SoC medications for 4 weeks prior to first dosing of study treatment. * Ability to communicate well with the investigator, understand and agree to comply with the requirements of the study. Key Exclusion criteria: * Use of prohibited therapies. * Active viral, bacterial or other infections requiring systemic treatment at the time of screening or baseline or history of recurrent clinically significant infection. * Plans for administration of live vaccines during the study period. * Uncontrolled co-existing serious disease. * Pregnant or nursing (lactating) women. * Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug. * US (and other countries, if locally required): sexually active males unless using barrier protection during intercourse with women of child-bearing potential while taking study treatment. Other protocol-defined inclusion/exclusion criteria may apply.
- Anniston, Alabama, United States
- Fullerton, California, United States
- La Palma, California, United States
- Winter Park, Florida, United States
- Lawrenceville, Georgia, United States
- Indianapolis, Indiana, United States
- Baton Rouge, Louisiana, United States
- Grand Blanc, Michigan, United States
- Middleburg Heights, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Duncansville, Pennsylvania, United States
- Jackson, Tennessee, United States
- Memphis, Tennessee, United States
- Bellaire, Texas, United States
- Mesquite, Texas, United States
- San Antonio, Texas, United States
- Spring, Texas, United States
- Quilmes, Buenos Aires, Argentina
- San Miguel Tucuman, Tucumán Province, Argentina
- Buenos Aires, Argentina
- Buenos Aires, Argentina
- Hamilton, Ontario, Canada
- Toronto, Ontario, Canada
- Rimouski, Quebec, Canada
- Trois-Rivières, Quebec, Canada
- Brno, Czechia
- Prague, Czechia
- Uherské Hradiště, Czechia
- Debrecen, Hajdu Bihar Megye, Hungary
- Budapest, Hungary
- + 7 more on CT.gov