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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
XBiotech, Inc.
ClinicalTrials.gov Identifier:
NCT01427699
First received: August 31, 2011
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: T2-18C3 therapeutic antibody
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of an Anti-Inflammatory Therapeutic Antibody (MABp1) in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by XBiotech, Inc.:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    The safety and tolerability of T2-18C3 will be determined by observing patients for clinical adverse events, changes in vital signs, and changes in laboratory parameters such as hematology and chemistry.


Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Serum levels of T2-18C3 will be measured in patients

  • Preliminary Efficacy [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    The ability of T2-18C3 to improve glycemic control will be measured by comparing the change in glycosylated hemoglobin levels of patients from baseline to day 90.


Enrollment: 7
Study Start Date: June 2011
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T2-18C3 therapeutic antibody
9 subjects will receive the T2-18C3 therapeutic antibody.
Drug: T2-18C3 therapeutic antibody
1.25 mg/kg Intravenous infusion every 2 weeks for a total of 4 doses.

Detailed Description:

This is a phase I, open label study of the safety and pharmacokinetics of T2-18C3 in patients with T2D. Nine patients will receive four biweekly IV infusions of the study drug, T2-18C3, at a dose level of 1.25 mg/kg. These patients will be followed for a total of 90 days to examine safety, pharmacokinetics, and preliminary efficacy.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427699

Locations
Switzerland
University Hospital of Basel
Basel, Switzerland, CH-4031
Sponsors and Collaborators
XBiotech, Inc.
  More Information

No publications provided

Responsible Party: XBiotech, Inc.
ClinicalTrials.gov Identifier: NCT01427699     History of Changes
Other Study ID Numbers: 2010-PT011
Study First Received: August 31, 2011
Last Updated: October 29, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Antibodies
Immunoglobulins
Anti-Inflammatory Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014