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

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

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.

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