RecruitingRecruiting
Long-Term Outcomes of Teplizumab in Routine Clinical Care
NCT07360080 · Sanofi
In plain English
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Official title
Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care
About this study
Enrolled participants will be followed for up to 10 years depending on the time the participants are included after initiating teplizumab treatment.
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.
Study design
Enrollment target: 1000 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2026-03-19
Estimated completion: 2035-10-29
Last updated: 2026-05-27
Interventions
Drug: Teplizumab
Primary outcomes
- • Time from teplizumab infusion start to the onset of Stage 3 T1D (From start of infusion to maximum of 10 years)
Sponsor
Sanofi · industry
Contacts & investigators
ContactTrial Transparency email recommended (Toll free for US & Canada) · contact · contact-us@sanofi.com · 800-633-1610
All locations (8)
Investigational Site Number: 8400003Recruiting
Atlanta, Georgia, United States
Investigative Site Number: 8400004Recruiting
Atlanta, Georgia, United States
Investigative Site Number: 8400002Recruiting
Syosset, New York, United States
Investigational Site Number: 8400005Recruiting
Sandy City, Utah, United States
Investigative Site Number: 3760003Recruiting
Petah Tikva, Israel
Investigative Site Number: 3760002Recruiting
Ramat Gan, Israel
Investigational Site Number: 3760001Recruiting
Ramat Gan, Israel
Investigative Site Number: 7840001Recruiting
Abu Dhabi, United Arab Emirates