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NCT03875729COMPLETEDanonymous

Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized Fc Receptor (FcR) Non-Binding Anti-cluster of Differentiation 3 (CD3) Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

Sponsor

Source record

Provention Bio, Inc.

Phase

Source record

Phase 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

Source & freshness

Source record

NCT ID

NCT03875729

Original source

ClinicalTrials.gov

Source last updated

Apr 24, 2024

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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View original source fields

NCT ID

NCT03875729

Title

Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized Fc Receptor (FcR) Non-Binding Anti-cluster of Differentiation 3 (CD3) Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

Sponsor

Provention Bio, Inc.

Status

COMPLETED

Phase

Phase 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

Provention Bio, Inc. conducted a Phase 3 trial to evaluate the efficacy and safety of teplizumab, a humanized anti-CD3 monoclonal antibody, in children and adolescents aged 8-17 with recent-onset Type 1 Diabetes (T1D). The study aimed to preserve β cell function and slow the loss of β cells over 18 months.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized Fc Receptor (FcR) Non-Binding Anti-cluster of Differentiation 3 (CD3) Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT03875729

Status

COMPLETED

Phase

Phase 3

Sponsor

Provention Bio, Inc.

Executive brief

Investment-Ready Snapshot

Provention Bio, Inc. conducted a Phase 3 trial to evaluate the efficacy and safety of teplizumab, a humanized anti-CD3 monoclonal antibody, in children and adolescents aged 8-17 with recent-onset Type 1 Diabetes (T1D). The study aimed to preserve β cell function and slow the loss of β cells over 18 months.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedApr 24, 2024
Internal syncJun 05, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT03875729

Indication

Type 1 Diabetes Mellitus

Modality

monoclonal antibody

Target

Type 1 Diabetes Mellitus

Intervention

teplizumab, Placebo

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.