Long-Term Outcomes of Teplizumab in Routine Clinical Care
AL1GN
Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care
2 other identifiers
observational
1,000
2 countries
2
Brief Summary
This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2026
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2026
CompletedFirst Posted
Study publicly available on registry
January 22, 2026
CompletedStudy Start
First participant enrolled
March 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 29, 2035
April 17, 2026
April 1, 2026
9.6 years
January 14, 2026
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time from teplizumab infusion start to the onset of Stage 3 T1D
From start of infusion to maximum of 10 years
Secondary Outcomes (27)
Proportion of participants who complete teplizumab treatment course
Up to end of infusion, maximum of 5 years
Number of participants with adverse events during the infusion period
Till 6 weeks post last infusion, maximum of 5 years
Number of participants with adverse events of special interest and serious adverse events
From 6 weeks post last infusion through the follow-up, maximum of 10 years
Number of participants with T1D-related complications
From infusion up to end of study, maximum of 10 years
Glycemic control assessment values
From baseline through follow-up, maximum of 10 years
- +22 more secondary outcomes
Study Arms (1)
Patients with Stage 2 Type 1 Diabetes (T1D) who received Teplizumab
Interventions
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Eligibility Criteria
Patients diagnosed with Stage 2 T1D who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment. Approximately 1000 participants, in 85 sites across 19 countries will be enrolled over 5 years.
You may qualify if:
- Participants who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment.
- Participants must have a confirmed diagnosis of Stage 2 T1D according to the treating physician at the time of the first infusion of teplizumab.
- (Note: Participants who progress to Stage 3 T1D by Week 6 will still be eligible, provided they were in Stage 2 at the time of the first teplizumab infusion.)
- Participants (or their legal guardians, as applicable) who provide appropriate written or electronic informed consent/assent as applicable for the age of the participant and as per local regulations.
You may not qualify if:
- Participants who had participated in a previous clinical trial for teplizumab.
- Participants enrolled in a clinical trial within 6 months prior to study enrollment.
- (Note: Participants enrolled in other observational studies may be included.)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (2)
Investigational Site Number: 8400005
Sandy City, Utah, 84093, United States
Investigational Site Number: 3760001
Ramat Gan, 5265601, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2026
First Posted
January 22, 2026
Study Start
March 19, 2026
Primary Completion (Estimated)
October 29, 2035
Study Completion (Estimated)
October 29, 2035
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.