Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04270942 · ClinicalTrials.gov registry record · Phase 2
At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)
A Phase 2 study, sponsored by Provention Bio, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT04270942: Completed Phase 2 study, sponsored by Provention Bio, a Sanofi Company.
NCT04270942 is a Phase 2 study that has completed, run by Provention Bio, a Sanofi Company. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04270942, a Phase 2 study, has completed, sponsored by Provention Bio, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
This study was an extension of the NIH-sponsored At-Risk (TN-10) type 1 diabetes study (NCT 01030861). Teplizumab-treated and placebo-treated participants in the NIH trial who developed clinical type 1 diabetes after the conclusion of that trial, were eligible to enroll and receive teplizumab treatment within one year of diagnosis of clinical type 1 diabetes.
Primary Outcome
An AE was any untoward medical occurrence in a participant or clinical study participant,temporally associated with use of study dose,whether or not considered related to study dose.AESI was any AE that met any of following:All \>=Grade 3 infections (including all opportunistic infections);acute mononucleosis-like illness;lymphomas or other malignancies;severe hypoglycemic episode;\>=Grade 3 liver function abnormalities, thrombocytopenia, neutropenia or rash;\>= Grade 4 allergic/hypersensitivity
Interventions
- DRUG teplizumab 1 mg/mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2020-02-26 |
| Est. Completion | 2024-01-22 |
| Phase | Phase 2 |
What the finished NCT04270942 record still lists
NCT04270942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which teplizumab 1 mg/mL is the first listed.
NCT04270942 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04270942 about?
NCT04270942 is a clinical study titled "At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)". This study was an extension of the NIH-sponsored At-Risk (TN-10) type 1 diabetes study (NCT 01030861). Teplizumab-treated and placebo-treated participants in the NIH trial who developed clinical type 1 diabetes after the conclusion of that trial, were eligible to enroll and receive teplizumab treatm...
What is the current status of trial NCT04270942?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2020-02-26. Estimated completion is 2024-01-22.
What interventions are being tested in trial NCT04270942?
The interventions under investigation include: teplizumab 1 mg/mL (DRUG).
Who is sponsoring clinical trial NCT04270942?
This trial is sponsored by Provention Bio, a Sanofi Company, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04270942's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI