NCT07360080 Long-Term Outcomes of Teplizumab in Routine Clinical Care
| NCT ID | NCT07360080 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sanofi |
| Condition | Type 1 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-03-19 |
| Primary Completion | 2035-10-29 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2026-03-19 with a primary completion date of 2035-10-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Trial Transparency email recommended (Toll free for US & Canada)
✉ contact-us@sanofi.com📞 800-633-1610
Frequently Asked Questions
Who can join the NCT07360080 clinical trial?
This trial is open to participants of all sexes, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07360080 currently recruiting?
Yes, NCT07360080 is actively recruiting participants. Contact the research team at contact-us@sanofi.com for enrollment information.
Where is the NCT07360080 trial being conducted?
This trial is being conducted at Washington D.C., United States, Atlanta, United States, Atlanta, United States, New York, United States and 8 additional locations.
Who is sponsoring the NCT07360080 clinical trial?
NCT07360080 is sponsored by Sanofi. The trial plans to enroll 1,000 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.