NCT07360080Recruiting
Long-Term Outcomes of Teplizumab in Routine Clinical Care
Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 14 Jan 2026
- Start date
- 19 Mar 2026
- Primary completion date
- 29 Oct 2035
- Lead sponsor
- Sanofi
- Diseases
- Type 1 diabetes
- NCT number
- NCT07360080
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 19 Mar 2026 to the primary completion date, 29 Oct 2035
- 10 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Abu Dhabi | United Arab Emirates | Recruiting |
| - Coordinator of this site? Confirm its status | Abu Dhabi | United Arab Emirates | Recruiting |
| - Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| - Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| - Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Sandy City | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Syosset | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.