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

History of Changes

Tracking Information
First Received Date ^ICMJE	August 31, 2011
Last Updated Date	October 29, 2012
Start Date ^ICMJE	June 2011
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 31, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01427699 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 31, 2011)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of the Safety and Pharmacokinetics of an Anti-Inflammatory Therapeutic Antibody (MABp1) in Patients With Type 2 Diabetes
Official Title ^ICMJE	A Phase II Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of an Anti-Inflammatory Therapeutic Antibody (MABp1) in Patients With Type 2 Diabetes
Brief 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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Type 2 Diabetes
Intervention ^ICMJE	Drug: T2-18C3 therapeutic antibody 1.25 mg/kg Intravenous infusion every 2 weeks for a total of 4 doses.
Study Arm (s)	Experimental: T2-18C3 therapeutic antibody 9 subjects will receive the T2-18C3 therapeutic antibody. Intervention: Drug: T2-18C3 therapeutic antibody
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	7
Completion Date	Not Provided
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Switzerland

Administrative Information
NCT Number ^ICMJE	NCT01427699
Other Study ID Numbers ^ICMJE	2010-PT011
Has Data Monitoring Committee	No
Responsible Party	XBiotech, Inc.
Study Sponsor ^ICMJE	XBiotech, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	XBiotech, Inc.
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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