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| Name | Class |
|---|---|
| XOMA (US) LLC | INDUSTRY |
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To assess the effects of treatment with XOMA 052 on beta-cell function and insulin production in subjects with well-controlled Type 1 diabetes. The safety, tolerability, and pharmacokinetics (PK) of XOMA 052 will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XOMA 052 | Active Comparator | 0.3 mg/kg XOMA 052. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections |
|
| Placebo | Placebo Comparator | 0.3 mg/kg placebo. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XOMA 052 | Drug | 0.3 mg/kg XOMA 052. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections |
| Measure | Description | Time Frame |
|---|---|---|
| C-peptide level | incremental AUC over 120 minutes during the MMTT at Day 112 compared to baseline (Day 0 pre-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin requirements | 3-day average daily insulin dose at baseline (Day -3 through Day -1) compared to Day 112 (Day 109 through Day 111) | |
| HbA1c levels | from baseline (Day 0 pre-dose) at Day 112 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Donath, Prof. | University Hospital, Basel, Switzerland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C547697 | gevokizumab |
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| Placebo | Drug | 0.3 mg/kg Placebo. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections |
|
| fasting glucose | from baseline (Day 0 pre-dose) at Day 112 |
| fasting glucagon | from baseline (Day 0 pre-dose) at Day 112 |
| cortisol | from baseline (Day 0 pre-dose) at Day 112 |
| markers of systemic inflammation (Interleukin-6, Interleukin-8, Tumor Necrosis Factor α, hs-CRP) | from baseline (Day 0 pre-dose) at Day 112 |
| adipokines | from baseline (Day 0 pre-dose) at Day 112 |
| meal-stimulated Glucagon like peptide-1 | AUC over 120 minutes at Day 112 compared to baseline (Day 0 pre-dose) |
| meal-stimulated gastric inhibitory polypeptide | AUC over 120 minutes at Day 112 compared to baseline (Day 0 pre-dose) |
| lipids profile | from baseline (Day 0 pre-dose) at Day 112 |
| Change in fatigue according to the Fatigue Scale for Motor and Cognitive Functions (FSMC) questionnaire | from baseline at Day 112 |
| Anti XOMA 052 Antibodies | from baseline (Day 0 pre-dose) at Day 112 |
| Number of Adverse Events | from baseline (Day 0 pre-dose) at Day 364 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |