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The primary objective of the study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of Epratuzumab in Japanese subjects with moderate to severe general SLE as add on to standard of care treatment during the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator |
| |
| Epratuzumab 600 mg Group | Experimental |
| |
| Epratuzumab 100 mg Group | Experimental |
| |
| Epratuzumab 400 mg Group | Experimental |
| |
| Epratuzumab 1200 mg Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | Placebo infusions at study weeks 0, 1, 2, and 3. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve (AUC) | AUC is defined as the area under the plot of plasma concentration of Epratuzumab against time after administration per subject. All measurements taken in the study (at administration day [day 0, 7, 14, 21] and the next four days of each administration day and week-4, 6, 8, 10, 12) are used to calculate AUC | From baseline to 12 weeks |
| Half-life (t1/2) | Half-life is defined as the time taken for plasma concentrations of Epratuzumab to decline by one half per subject. All measurements taken in the study (at administration day [day 0, 7, 14, 21] and the next four days of each administration day and week-4, 6, 8, 10, 12) are used to calculate Half-life. | From baseline to 12 weeks |
| Maximum plasma Concentration (Cmax) | Plasma concentration of Epratuzumab for each pharmacokinetics parameter is measured at administration day (day 0, 7, 14, 21) and the next four days of each administration day and week-4, 6, 8, 10, 12. | From Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of anti-epratuzumab in plasma during administration over 12 weeks | Blood drawing for anti- epratuzumab is carried out at initial administration day (day 0) and end of the evaluation period (week 12). | Day 0 (initial administration day) and week 12 (end of the evaluation period) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 09 | Fukuoka | Japan | ||||
| 10 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33687069 | Derived | Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2. | |
| 26382733 | Derived | Tsuru T, Tanaka Y, Kishimoto M, Saito K, Yoshizawa S, Takasaki Y, Miyamura T, Niiro H, Morimoto S, Yamamoto J, Lledo-Garcia R, Shao J, Tatematsu S, Togo O, Koike T. Safety, pharmacokinetics, and pharmacodynamics of epratuzumab in Japanese patients with moderate-to-severe systemic lupus erythematosus: Results from a phase 1/2 randomized study. Mod Rheumatol. 2016;26(1):87-93. doi: 10.3109/14397595.2015.1079292. Epub 2015 Oct 19. |
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| Epratuzumab 400 mg |
| Biological |
Epratuzumab 400 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3. |
|
| Epratuzumab 1200 mg | Biological | Epratuzumab 1200 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3. |
|
| Epratuzumab 100 mg | Biological | Epratuzumab 100 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3. |
|
| Epratuzumab 600 mg | Biological | Epratuzumab 600 mg infusions at study weeks 0, 1, 2, and 3. |
|
| Fukuoka |
| Japan |
| 11 | Fukuoka | Japan |
| 03 | Kitakyushu | Japan |
| 01 | Tokyo | Japan |
| 08 | Tokyo | Japan |
| 12 | Urayasu | Japan |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C448700 | epratuzumab |
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