Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 Diabetes

Study Overview
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Brief Summary
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The study hypothesis is that XOMA 052 may inhibit beta-cell destruction and enhance beta-cell regeneration. The purpose of this study is to assess the effects of XOMA 052 on beta-cell function and insulin production.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well-controlled Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Xoma 052
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Stable Type 1 diabetes of > 2 year duration No clinically significant change in treatment regimen for T1D Age ≥ 18 years and ≤ 55 years HbA1c < 7.0% Positive GAD65 and/or IA-2 auto-antibodies Peak C-peptide > 100 pM following IV injection of 1 mg glucagon Body-mass index (BMI) > 18 and < 28 kg/m2 Willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study Exclusion criteria: Current infection or history of infection Positive for Hep B surface antigen (HBsAg), Hep C virus (HCV), or HIV History of tuberculosis or positive PPD test Presence of foot, leg, or decubitus ulcers Current immunosuppressive treatment or documented immunodeficiency History of severe allergic or anaphylactic reactions History of asthma requiring systemic corticosteroid therapy Coronary intervention (PCI, stent placement) or hospitalization for cardiovascular condition within the last 12 months Uncontrolled hypertension History of congestive heart failure (NYHA Class III or IV) History of a coronary event within the last 12 months Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding History of malignancy within the last 5 years Receipt of a live (attenuated) vaccine within the last 3 months Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: XOMA 052<br> | Drug: Xoma 052<br>* Sterile solution subcutaneously administered every 4 weeks for 12 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Sterile solution subcutaneously administered every 4 weeks for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in beta-cell function as measured by change in C-peptide level during thd MMTT (Mixed meal tolerance test) at Day 112 compared to baseline (Day 0 pre-dose) |  | Day 0 pre-dose and Day 112 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events. |  | Day 0 (baseline) through Day 364 | 
| Change in insulin requirements |  | Day -3 through Day 0 pre-dose and Day 109 through Day 112) | 
| Change in HbA1c levels |  | Day 0 pre-dose and Day 112 | 
| Change in fasting glucose |  | Day 0 pre-dose and Day 112 | 
| Change in fasting glucagon and cortisol |  | Day 0 pre-dose and Day 112 | 
| Change in systemic inflammation markers |  | Day 0 pre-dose and Day 112 | 
| Change in meal-stimulated GLP-1 and GIP |  | Day 0 pre-dose and Day 112 | 
| Change in lipids profile |  | Day 0 pre-dose and Day 112 | 
| Measurement of serum concentrations of XOMA 052 |  | Day 0 pre-dose, Day 28, Day 56, Day 84, Day 112, Day 182, and Day 364 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Type 1