An Extension of Study CP-MGA031-01 to Evaluate the Long-Term Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Patients With Recent-Onset Type 1 Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- MacroGenics
- Enrollment
- 219
- Locations
- 1
- Primary Endpoint
- The Number of Participants Who Experience an Adverse Event, Serious Adverse Event or Adverse Event of Special Interest.
Overview
Brief Summary
The purpose of this study is to assess the long term safety and efficacy in subjects with Type 1 Diabetes Mellitus who completed the Protege Study (CP-MGA031-01).
Detailed Description
The primary objective of the extension study is to assess long-term safety, with particular focus on the development of serious adverse events (SAEs), adverse events of special interest (AESIs) including opportunistic infections and lymphoproliferative disease, and other immediately reportable events (IREs), in subjects with recent-onset T1DM who complete CP-MGA031-01.
The secondary objectives of the extension study are to: 1) assess long-term efficacy; 2) evaluate immunological effects(North America only); 3) measure anti-teplizumab antibody levels;4) assess Health Related Quality of Life Questionnaires.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 10 Years to 37 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Complete Protocol CP-MGA031-01 (i.e., all subjects who complete Study Day 728, regardless of how many doses of study drug are received).
- •Provide written informed consent.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The Number of Participants Who Experience an Adverse Event, Serious Adverse Event or Adverse Event of Special Interest.
Time Frame: Duration of study participation up to 15 months
Secondary Outcomes
- Mean HbA1c at 12 Months(Month 12)
- C-peptide Area Under the Curve (AUC) at 6 Months(Month 6)
- Mean Values for Participant-reported Outcomes on the 5-dimension European Quality of Life Questionnaire. (EQ-5D)(Month 6)
- Pediatric Quality of Life Questionnaire Total Score(Month 12)
- Proportion of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.(Month 12)
- Proportion of Subjects With HbA1c <6.5%(Month 6)
- Mean HbA1c at 6 Months(6 months)
- Mean Values for Participant-reported Outcomes on the EQ-5D(Month 12)
- Human Anti-human Antibody (HAHA) Levels(Month 6 and 12)
- C-peptide AUC at 12 Months(Month 12)
- Total Daily Insulin Usage at 6 Months(Month 6)
- Total Daily Insulin Usage at 12 Months(Month 12)
- Percentage of Cells by Immunophenotype(Month 6)