Novartis Pharmaceuticals
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 optional cohort may 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.
Sjogren's Disease
Systemic Lupus Erythematosus
Rheumatoid Arthritis
VAY736 1ml PFS
VAY736 2 ml PFS
VAY736 2ml AI
PHASE2
The study consists of the following periods: Screening period (up to 4 weeks): Following the signing of the informed consent, participants will be assessed for eligibility during this period of up to 4 weeks. Treatment Period 1 + Treatment Period 2, (Week 0 to Week 24): After completion of the screening period, eligible participants will be randomized at the Baseline visit (Week 0) to one of the 2 treatment sequences (treatment switch at Week 12) in a ratio of 1:1 described below: * Cohort 1: * Sequence 1: ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (1 x 2 mL AI) monthly + SoC in Treatment Period 2 * Sequence 2: ianalumab 300 mg s.c. (1 x 2 mL AI) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 2 * Cohort 2 (Optional): * Sequence 1: ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (1 x 2 mL PFS) monthly + SoC in Treatment Period 2 * Sequence 2: ianalumab 300 mg s.c. (1 x 2 mL PFS) monthly + SoC in Treatment Period 1 and ianalumab 300 mg s.c. (2 x 1 mL PFS) monthly + SoC in Treatment Period 2 In addition, within each sequence, participants will be further randomized to one of the predetermined injection sites with equal allocation, resulting in a total randomization combination of four (2 sequences x 2 injection sites) for Cohort 1 and six (2 sequences x 3 injection sites) for Cohort 2, respectively. Extended Treatment period (Week 24 to Week 72): After completion of Week 24 assessment, all participants (who did not discontinue during treatment period) will have the option to enter the extended treatment period to receive ianalumab 300 mg s.c. (Cohort 1: 2 mL AI; Cohort 2: 2 mL PFS) monthly up to Week 68. The end of treatment (EOT) visit will be performed 4 weeks after the last study treatment administration, i.e., at Week 72. Mandatory Post-Treatment safety follow-up period (from Week 72 to Week 88): Participants who completed the last study treatment or prematurely discontinued from study treatment will enter the post-treatment safety follow-up period. Conditional Post-Treatment safety follow-up period (from Week 88 to Week 176) Post-treatment follow-up will be performed until B-cell recovery or up to 2 years. B-cell recovery is defined when CD19+ B-cell counts return to \>= 50 cells/μL or \>= 80% of baseline value, whichever occurs earlier.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 140 participants |
Masking : | NONE |
Primary Purpose : | BASIC_SCIENCE |
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 |
Actual Study Start Date : | 2024-07-02 |
Estimated Primary Completion Date : | 2025-07-29 |
Estimated Study Completion Date : | 2029-02-08 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 70 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Pinnacle Research Group Llc .
Anniston, Alabama, United States, 36207
RECRUITING
Providence Medical Foundation
Fullerton, California, United States, 92835
RECRUITING
Advanced Medical Research
The Palm, California, United States, 90623
RECRUITING
Conquest Research
Winter Park, Florida, United States, 32789
RECRUITING
Parris and Associates Rheumatology
Lawrenceville, Georgia, United States, 30044
RECRUITING
Ahmed Arif Medical Research Center
Great White, Michigan, United States, 48439
RECRUITING
Paramount Med Rsrch and Consult LLC
Middleburg Heights, Ohio, United States, 44130
RECRUITING
RAO Research LLS
Oklahoma City, Oklahoma, United States, 73116
RECRUITING
Altoona Center for Clin Res .
Duncansville, Pennsylvania, United States, 16635
RECRUITING
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
RECRUITING
Shelby Research LLC
Memphis, Tennessee, United States, 38119
RECRUITING
Novel Research LLC
Bellaire, Texas, United States, 77401
RECRUITING
Southwest Rheum Rsrch LLC
Mesquite, Texas, United States, 75150
RECRUITING
Uni of Texas Health Science Center
Saint Anthony, Texas, United States, 78284
RECRUITING
Advanced Rheumatology of Houston .
Spring, Texas, United States, 77382
RECRUITING
Novartis Investigative Site
Trois Rivieres, Quebec, Canada, My heartache
RECRUITING
Novartis Investigative Site
Krakow, Poland, 30 002