NCT00385697COMPLETEDanonymous

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of MGA031, a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Sponsor

Source record

MacroGenics

Phase

Source record

Phase 2/3

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Type 1 Diabetes Mellitus

Indication / condition

AI-normalized

Type 1 Diabetes Mellitus

Intervention

Source record

Teplizumab, Placebo

Related intelligence directories

Indication directory: Type 1 Diabetes Mellitus Modality directory: monoclonal antibody Target directory: Type 1 Diabetes Mellitus

Source & freshness

Source record

NCT ID

NCT00385697

Original source

ClinicalTrials.gov

Source last updated

Dec 05, 2023

Ingested at

May 31, 2026

Internal sync

Jun 05, 2026

Model version

trialsignal-ai-v1

Normalized confidence

88%

Validation status

validated

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NCT ID

NCT00385697

Title

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of MGA031, a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Sponsor

MacroGenics

Status

COMPLETED

Phase

Phase 2/3

Condition raw

Type 1 Diabetes Mellitus

Condition normalized

Type 1 Diabetes Mellitus

Modality raw

Type 1 Diabetes Mellitus

Modality normalized

monoclonal antibody

Target raw

Type 1 Diabetes Mellitus

Target normalized

Type 1 Diabetes Mellitus

Interventions

Teplizumab, Placebo

Public preview

Source record

The Protégé Study evaluated MGA031 (teplizumab), a humanized anti-CD3 monoclonal antibody, for its efficacy and safety in reducing insulin requirements and improving blood sugar levels in children and adults with recent-onset type 1 diabetes. Conducted by MacroGenics in collaboration with Eli Lilly, the trial enrolled 554 participants across multiple centers.

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Investment-Ready Snapshot

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of MGA031, a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Source & freshness

Public preview

Create an account to unlock this report

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of MGA031, a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Investment-Ready Snapshot

Provenance

Protocol Description

Outcome Measures

Eligibility

Known Results And Readout Context

Patent And IP Landscape

Contacts