Long-term outcomes of teplizumab in routine care

Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care

This project will see if teplizumab given to people with Stage 2 Type 1 Diabetes delays the start of Stage 3 diabetes and how it affects their quality of life over time.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Sex: All
• Sponsor: Sanofi (industry)
• Drugs / interventions: teplizumab
• Locations: 2 sites (Sandy City, Utah and 1 other locations)
• Trial ID: NCT07360080 on ClinicalTrials.gov

What this trial studies

This is a prospective, observational cohort following people who receive teplizumab as part of routine clinical care across multiple sites. Enrolled participants must have received at least one teplizumab infusion within six weeks before enrollment and were classified as Stage 2 T1D at the time of first infusion; they will be followed for up to 10 years depending on enrollment timing. The study will collect clinical outcomes, timing of progression to Stage 3 T1D, and patient-reported outcomes addressing emotional and psychosocial aspects of living with T1D. Exclusion criteria include prior participation in a teplizumab clinical trial or enrollment in a clinical trial within six months before joining this cohort.

Who should consider this trial

Good fit: Ideal candidates are people with Stage 2 Type 1 Diabetes who received at least one teplizumab infusion within six weeks before enrolling and who can give informed consent.

Not a fit: Patients who previously participated in a teplizumab clinical trial, who enrolled in another clinical trial within the prior six months, or who did not receive teplizumab while in Stage 2 are less likely to benefit from this observational follow-up.

Why it matters

Potential benefit: If successful, results could show sustained delay in clinical onset of Type 1 Diabetes and provide real-world evidence about quality-of-life benefits from teplizumab.

How similar studies have performed: Randomized clinical trials have shown teplizumab can delay the onset of clinical Type 1 Diabetes in high-risk individuals, but long-term, real-world outcome data remain limited.

Eligibility criteria

Inclusion Criteria -

* 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.

Exclusion Criteria -

* 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.

Where this trial is running

Sandy City, Utah and 1 other locations

• Investigational Site Number: 8400005 — Sandy City, Utah, United States (RECRUITING)
• Investigational Site Number: 3760001 — Ramat Gan, Israel (RECRUITING)

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)

Conditions: Type 1 Diabetes