Recruiting

Teplizumab

Sponsor:

Sanofi

Code:

NCT07360080

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Teplizumab

Study Details

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.

Conditions

Type 1 Diabetes

Study ID

NCT07360080

Start date

Mar 19, 2026

Status verified date

Aug, 2026

Completion date

Oct 29, 2035

Anticipated

Primary completion date

Oct 29, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Stage 2 Type 1 Diabetes (T1D) who received Teplizumab

Interventions

Teplizumab

This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Primary outcome measure

  • Time from teplizumab infusion start to the onset of Stage 3 T1D [ Time Frame: From start of infusion to maximum of 10 years ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610contact-us@sanofi.com

Locations

Investigational Site Number: 8400003

Recruiting

Atlanta, Georgia, United States, 30318-2538

Investigational Site Number: 8400004

Recruiting

Atlanta, Georgia, United States, 30329-3102

Investigational Site Number: 8400001

Recruiting

New York, New York, United States, 10016

Investigational Site Number: 8400002

Recruiting

Syosset, New York, United States, 11791

Investigational Site Number: 8400005

Recruiting

Sandy City, Utah, United States, 84093

More Information

Sponsor

Sanofi

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sanofi on 2026-08-25.