NCT00998699

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2010

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 4, 2014

Status Verified

March 1, 2014

Enrollment Period

3.5 years

First QC Date

October 19, 2009

Last Update Submit

March 3, 2014

Conditions

Type 1 Diabetes

Keywords

DiabetesType 1

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

XOMA 052

ACTIVE COMPARATOR
Drug: Xoma 052

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Xoma 052DRUG

Sterile solution subcutaneously administered every 4 weeks for 12 weeks

XOMA 052
PlaceboDRUG

Sterile solution subcutaneously administered every 4 weeks for 12 weeks

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Basel, Switzerland

Location

Unknown Facility

Zurich, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Interventions

gevokizumab

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Marc Donath, MD

    UniversitaetsSpital Zuerich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2009

First Posted

October 20, 2009

Study Start

February 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

March 4, 2014

Record last verified: 2014-03

Locations

CH(2)