Recent-onset type 1 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Interventions
Product Name: Teplizumab / MGA031 (hOKT3?1 (Ala-Ala) )
Product Code: MGA031
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Teplizumab
CAS Number: 876387-05-2
Current S
Sponsors
MacroGenics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Complete Protocol CP-MGA031-01 (i.e., all subjects who complete Study Day 728, regardless of how many doses of study drug are received). 2. Provide written informed consent. Written assent will be obtained for subjects under 18 years of age, according to applicable regulations. If possible, written informed consent and/or assent should be obtained for Protocol CP-MGA031-02 at the last visit in CP-MGA031-01. Informed Consent must be obtained after all procedures for Study Day 728 have been completed. The investigator is to give the subject ample time to decide about participation in CP-MGA031-02 by informing the subject of the extension study before the last visit of CP-MGA031-01. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: There are no exclusion criteria for this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives of the extension study are to: 1) assess long-term efficacy; 2) measure anti-teplizumab antibody levels; and 3) assess PRO (Patient Reported Outcomes).;Main Objective: 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.;Primary end point(s): Safety Endpoints Safety endpoints will include the number and percentage of subjects who experience an SAE, AESI, or other IRE. Efficacy Endpoints With regard to HbA1c levels and total daily insulin use, efficacy endpoints will include: • the proportion of subjects who have a total daily insulin dose <0.5 U/kg/day and an HbA1c level <6.5%; • the proportion of subjects who have a total daily insulin dose <0.5 U/kg/day and an HbA1c level <7.0%; • the proportion of subjects who have a total daily insulin dose <0.5 U/kg/day; • the proportion of subjects with an HbA1c level <6.5%; • the proportion of subjects with an HbA1c level <7.0%; and • mean HbA1c levels within each treatment group. | — |
Countries
Czech Republic, Estonia, Latvia, Spain, Sweden
Outcome results
None listed