Recent Updates
Recently added Catalysts

Teplizumab

Phase 2

Type 1 Diabetes Mellitus | Monoclonal antibody | Metabolic |MacroGenics, Inc.|Last Updated: Dec 5, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment554
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00385697The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes MellitusPHASE2 COMPLETED 554 — — Oct 1, 2006Aug 1, 2011Dec 5, 2023115 United States, Canada +14
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number 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%.
52 weeks after randomization

This is a composite endpoint is based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5% at 52 weeks after randomization.

Number of Subjects in Segment 1 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%.
52 weeks after first dose

This is a composite endpoint based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5%

Mean HbA1c Change From Baseline in Segment 2
52 weeks after randomization

Comparison among study treatments of average change from baseline HbA1C. This endpoint will be assessed in a hierarchical manner only if the composite primary endpoint shows a statistically significant difference between arms

Mean HbA1c Change From Baseline in Segment 1
52 weeks after first dose

The average change in HbA1c levels after dosing.

Secondary Endpoints
Change From Baseline in C-peptide Area Under the Curve (AUC) in Segment 2
104 weeks after randomization
Change From Baseline in C-peptide AUC in Segment 1
104 weeks after first dose
Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 6.5%
104 weeks after randomization
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Double-blind Herold RegimenEXPERIMENTALFull dose of teplizumab IV for 14 days, repeated at Week 26
Double-blind 33.3% Herold RegimenEXPERIMENTALOne third full dose of teplizumab IV for 14 days, repeated at Week 26
Double-blind Curtailed Herold RegimenEXPERIMENTALFull dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26
Double-blind PlaceboPLACEBO_COMPARATORPlacebo IV dosing daily for 14 days repeated at Week 26
Open-label Herold RegimenEXPERIMENTALFull dose of teplizumab IV for 14 days, repeated at Week 26
Interventions
NameTypeDescription
TeplizumabBIOLOGICALDaily IV dosing for 14 days, repeated at Week 26
PlaceboDRUGDaily IV dosing for 14 days, repeated at Week 26
Unlock Study Design Details
Eligibility Criteria
Age Range8 Years — 35 Years
SexALL
Healthy VolunteersNo
Study Sites115

Inclusion Criteria: Subjects must meet all of the following criteria: 1. Enrollment (Segment #1) or randomization (Segment #2) on Study Day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes. Study Day 0 is the first day of study drug dosing. 2. Diagnosis of type 1...

Countries:United StatesCanadaCzechiaEstoniaGermanyIndiaIsraelLatviaMexicoNetherlandsPolandRomaniaSpainSwedenUkraineUnited Kingdom
Unlock Eligibility Criteria