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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
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

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Coordinator of this site? Confirm its status
Abu DhabiUnited Arab EmiratesRecruiting
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Coordinator of this site? Confirm its status
Abu DhabiUnited Arab EmiratesRecruiting
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Coordinator of this site? Confirm its status
Petah TikvaIsraelRecruiting
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Coordinator of this site? Confirm its status
Ramat GanIsraelRecruiting
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Coordinator of this site? Confirm its status
Ramat GanIsraelRecruiting
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Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
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Coordinator of this site? Confirm its status
AtlantaUnited StatesRecruiting
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Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
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Coordinator of this site? Confirm its status
Sandy CityUnited StatesRecruiting
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Coordinator of this site? Confirm its status
SyossetUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.