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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020156-65 |
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This study investigated the safety and tolerability of VAY736 administered as single ascending doses of intravenous infusion, subcutaneous injection and repeated subcutaneous injections in rheumatoid arthritis patients.
This study had three sequential parts which investigated the safety and tolerability of VAY736 administered as single ascending doses of intravenous infusion (Part 1), single ascending doses of subcutaneous injection (Part 2), and repeated subcutaneous injections of fixed doses (Part 3), respectively, in rheumatoid arthritis patients. Part 1 was double blind, placebo controlled, with 11 cohorts. Part 2 was open-label study with 2 dosing cohorts. Part 3 was open-label study with 1 fixed-dose cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAY736 | Experimental | VAY736 active |
|
| Placebo | Placebo Comparator | VAY736 placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAY736 | Biological | VAY736 treatment |
| |
| VAY736 placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as measured by the number of patients wth adverse events | Part 1 The number of patients with adverse events after single intravenous (i.v.) dose of VAY736. Patients are assessed weekly up to 34 weeks post dose or until B cells reach the recovery criteria Part 2 The number of patients with adverse events after single subcutaneous (s.c.) dose of VAY736. Patients are assessed weekly, bi-weekly, then every 4, 8 and 12 weeks up to 188 weeks post dose or until B cells reach the recovery criteria. Part 3 The number of patients with adverse events after repeated subcutaneous (s.c) injections of a fixed dose of VAY736. Patients are assessed bi-weekly, then every 4 weeks and 8 weeks up to 27 weeks from the first dose. | 27-188 weeks |
| Absolute bioavailability of VAY736: The ratio of area under curve (AUC) for s.c dose and for intravenous dose | Part 2 The ratio of area under curve (AUC) for single s.c dose and intravenous dose is determined | 188 weeks |
| Plasma pharmacokinetics of VAY736: The area under the plasma concentration-time curve from time zero to the end of the dosing interval (AUCtau) | In Part 3: After the first and last s.c. doses, the area under the plasma concentration-time curve from time zero to the end of the dosing interval (AUCtau) will be determined | 27 weeks |
| Plasma pharmacokinetics of VAY736: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) | In Part 3: After the first and last s.c. doses, the Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) will be determined. | 27 weeks |
| Plasma pharmacokinetics of VAY736: Observed maximum plasma concentration following drug administration (Cmax) |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacodynamics of VAY736 | B cell depletion/recovery after single i.v. dose of VAY736, single s.c. dose of VAY736 and multiple fixed s.c. doses of VAY736 administration in the 3 parts of the study | 27-188 weeks |
| Immunogenicity of VAY736 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Berlin | 10117 | Germany |
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| Label | URL |
|---|---|
| Results for CVAY736X2101 from the Novartis Clinical Trials Website | View source |
| A Plain Language Trial Summary is available on novartisclinicatrials.com | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000656267 | ianalumab |
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| Biological |
VAY736 placebo |
|
In Part 3:
After the first and last s.c. doses, the Observed maximum plasma concentration following drug administration (Cmax) will be determined
| 27 weeks |
| Plasma pharmacokinetics of VAY736: Time to reach the maximum concentration after drug administration (Tmax) | In Part 3: After the first and last s.c. doses, the time to reach the maximum concentration after drug administration (Tmax) will be determined | 27 weeks |
| Plasma pharmacokinetics of VAY736: The terminal elimination half-life (T1/2) | In Part 3: After the first and last s.c. doses, the terminal elimination half-life (T1/2) will be determined | 27 weeks |
| Plasma pharmacokinetics of VAY736: Area under the plasma concentration-time curve from time zero to infinity (AUCinf) | In Part 3: After the first and last s.c. doses, Area under the plasma concentration-time curve from time zero to infinity (AUCinf) will be determined. | 27 weeks |
| Plasma pharmacokinetics of VAY736: concentration of VAY736 during the treatment period, before each dose (Ctrough) | In Part 3: After the first and last s.c. doses, the concentration of VAY736 during the treatment period, before each dose (Ctrough) will be determined | 27 weeks |
| Safety and tolerability as measured by the percentage of patients wth adverse events | Part 1 The percentage of patients with adverse events after single intravenous (i.v.) dose of VAY736. Patients are assessed weekly up to 34 weeks post dose or until B cells reach recovery criteria. Part 2 The percentage of patients with adverse events after single subcutaneous (s.c.) dose of VAY736. Patients are assessed weekly, bi-weekly, then every 4, 8 and 12 weeks up to 68 weeks post dose or until B cells reach recovery criteria.. Part 3 The percentage of patients with adverse events after repeated subcutaneous (s.c) injections of a fixed dose of VAY736. Patients are assessed bi-weekly, then every 4 weeks and 8 weeks up to 27 weeks from the first dose. | 27-188 weeks |
Immunogenicity after administration of single i.v. dose of VAY736, single s.c. dose of VAY736 and multiple fixed s.c. doses of VAY736 in 3 parts of the study.
| 27-188 weeks |
| Plasma bioavailability of VAY736: The ratio of area under curve (AUC) for repeated s.c doses and for intravenous dose | Part 3 The ratio of area under curve (AUC) for repeated s.c doses and for intravenous dose is determined | 27 weeks |
| Plasma pharmacokinetics of VAY736: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) | The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) will be determined after single i.v. dose and s.c. dose of VAY736 in Part 1 and Part 2 respectively | 34-188 weeks |
| Plasma pharmacokinetics of VAY736: Area under the plasma concentration-time curve from time zero to infinity (AUCinf) | The area under the plasma concentration-time curve from time zero to infinity (AUCinf) will be determined after single i.v. dose and s.c. dose of VAY736 in Part 1 and Part 2 respectively. | 34-188 weeks |
| Plasma pharmacokinetics of VAY736: Observed maximum plasma concentration following drug Administration (Cmax) | The Observed maximum plasma concentration following drug administration (Cmax) will be determined after single i.v. dose and s.c. dose of VAY736 in Part 1 and Part 2 respectively | 34-188 weeks |
| Plasma pharmacokinetics of VAY736: Time to reach the maximum concentration after drug administration (Tmax) | The time to reach the maximum concentration after drug administration (Tmax) will be determined after single i.v. dose and s.c. dose of VAY736 in Part 1 and Part 2 respectively | 34-188 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |