Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic Patients

Compared to placebo, treatment with ChAgly CD3 has a beneficial effect on preservation of beta cell function and metabolic outcome in type 1 diabetic patients with recent clinical onset of disease that persists until 48 months after administration.

The investigators also hypothesize that in type 1 diabetic patients with recent clinical onset of disease compared to placebo, ChAgly CD3 will be safe and well tolerated between 18 and 48 months after administration, based on assessment of clinical and laboratory adverse events.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: Placebo; Drug: ChAgly CD3

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium
    • Universitair Ziekenhuis Antwerpen
  • Brussel, Belgium
    • Hopital Erasme
  • Brussels, Belgium, 1090
    • Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB
  • Leuven, Belgium, 3000
    • Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL
• Germany
  • Munich, Germany
    • Hopital Schwabbing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 45 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with Type 1 diabetes mellitus included in the phase II therapeutic trial with a humanized non-mitogenic CD3 monoclonal antibody (ChAgly CD3) at time of clinical diagnosis and who agree and are likely to comply with the investigator's instructions

Exclusion Criteria:

• Any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the patient
• Use of illicit drugs or over consumption of alcohol (> 3 beers/day)
• Being legally incapacitated, having significant emotional problems at the time of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: B	Drug: Placebo; 6 days
ACTIVE_COMPARATOR: A; ChAgly CD3	Drug: ChAgly CD3; 6 days treatment 8mg/d intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The difference in change in daily insulin need between baseline and month 48, between placebo and ChAgly CD3 treated patients	48 months

Collaborators and Investigators

• Sponsor: AZ-VUB
• Collaborators: KU Leuven; Universiteit Antwerpen; Erasme University Hospital
• Investigators: Principal Investigator: Bart Keymeulen, MD,PhD, Universitair Ziekenhuis Brussel

Publications and helpful links

General Publications

• Keymeulen B, Vandemeulebroucke E, Ziegler AG, Mathieu C, Kaufman L, Hale G, Gorus F, Goldman M, Walter M, Candon S, Schandene L, Crenier L, De Block C, Seigneurin JM, De Pauw P, Pierard D, Weets I, Rebello P, Bird P, Berrie E, Frewin M, Waldmann H, Bach JF, Pipeleers D, Chatenoud L. Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes. N Engl J Med. 2005 Jun 23;352(25):2598-608. doi: 10.1056/NEJMoa043980.
• Keymeulen B, Walter M, Mathieu C, Kaufman L, Gorus F, Hilbrands R, Vandemeulebroucke E, Van de Velde U, Crenier L, De Block C, Candon S, Waldmann H, Ziegler AG, Chatenoud L, Pipeleers D. Four-year metabolic outcome of a randomised controlled CD3-antibody trial in recent-onset type 1 diabetic patients depends on their age and baseline residual beta cell mass. Diabetologia. 2010 Apr;53(4):614-23. doi: 10.1007/s00125-009-1644-9. Epub 2010 Jan 14.

Study record dates

Study Major Dates

• Study Start: June 1, 2000
• Primary Completion (ACTUAL): March 1, 2007
• Study Completion (ACTUAL): March 1, 2007

Study Registration Dates

• First Submitted: February 22, 2008
• First Submitted That Met QC Criteria: February 22, 2008
• First Posted (ESTIMATE): February 29, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): September 29, 2008
• Last Update Submitted That Met QC Criteria: September 25, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: Diabetes Mellitus, type 1; ChAgly CD3
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: BK-AntiCD3-02