Long-Term Outcomes of Teplizumab in Routine Clinical Care (AL1GN)

Sanofi

Status: Begins enrollment this month

Conditions: Type 1 Diabetes

Treatments: Drug: Teplizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT07360080

OBS18569

U1111-1317-7939 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Enrolled participants will be followed for up to 10 years depending on the time the participants are included after initiating teplizumab treatment.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.)

Trial design

1,000 participants in 1 patient group

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

Treatment:

Drug: Teplizumab