A Study of the Safety and Pharmacokinetics of an Anti-Inflammatory Therapeutic Antibody (MABp1) in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if T2-18C3, a true human monoclonal antibody that blocks inflammation, is safe to use in patients with type 2 diabetes. The study will also be looking at the ability of T2-18C3 to improve control of blood sugar levels in diabetics by blocking inflammation in the pancreas.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC; XBiotech, Inc.
• Treatments: Anti-Inflammatory Agents; Antibodies; Immunoglobulins

Criteria

Inclusion Criteria:

• American Diabetes Association (ADA) diagnostic criteria for Type 2 Diabetes (T2D)

• HbA1c >7.0% and ≤ 10%

• Current T2D duration > 3 months at Screening

• T2D and other diseases must be stable. Stable disease is defined as disease which did not require a change in medication or dosing level on 4 or more consecutive days or 7 days in total within 28 days prior to Day 0.

• Age ≥ 18 and ≤ 70 at Screening

• BMI ≥ 23 and ≤ 40 kg/m2

• For female patients of child-bearing age, a negative serum pregnancy test. For patients with reproductive potential, a willingness to utilize adequate contraception (oral contraception plus a mechanical barrier) and not become pregnant (or have their partner[s] become pregnant) during the study

• Agrees not to change diet and exercise regimen during the trial

• Signed and dated Ethics Committee (EC) approved informed consent before any protocol-specific screening procedures are performed

Exclusion Criteria:

• Use of the following medications:

• Daily use of steroids or aspirin ≥ 700 mg per week

• Immunosuppressive treatment

• Thiazolidinediones

• Concomitant treatment with any other therapeutic antibody, or treatment with any biologic agent that blocks the IL-1 or TNFα signaling pathway

• Change in medication for diabetes within 28 days prior to Day 0, defined as a change in dosing level on 4 or more consecutive days or 7 days in total

• Hemoglobin <10.0 g/dL, WBC <3.0 x 103/mm3 , platelet count <125 x 103/mm3, creatinine > 1.5mg/dL, AST/ALT >2 x ULN, alkaline phosphatase >2 x ULN

• Abnormal, untreated T3, T4, thyroglobulin, or TSH levels or history of Grave's disease

• Known HIV antibody, hepatitis B surface antigen and/or hepatitis C antibody

• History of malignancy within 5 years prior to study entry other than carcinoma in situ of the cervix, or adequately treated, nonmetastatic squamous or basal cell carcinoma of the skin

• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies

• History of tuberculosis, positive PPD test, active atopic disease requiring medication, or asthma

• Infectious disease:

• CRP >30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening

• History of recurrent infection or predisposition to infection

• Active leg or foot ulcer

• Immunodeficiency

• Female patients who are pregnant, planning to become pregnant during the course of the study, or breast-feeding

• Receipt of a live (attenuated) vaccine within 3 months prior to Screening

• Major surgery within 28 days prior to Day 0

• Participation in an investigational drug or device trial within 30 days prior to Screening