Not a traditional drug phase: testing Teplizumab for Type 1 Diabetes
This is an watch-and-measure (no experimental treatment required), prospective cohort study designed to measure 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.
Official registry: https://clinicaltrials.gov/study/NCT07360080 · Sanofi · enrollment listed as 1,000
What this phase means
This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.
They plan to enroll about 1,000 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care
Interventions: Teplizumab
Primary outcome (registry wording): Time from teplizumab infusion start to the onset of Stage 3 T1D
Who it is for (from 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.)
Who the registry excludes
- 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 watch-and-measure (no experimental treatment required) 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
Public study contact (from the registry)
Trial Transparency email recommended (Toll free for US & Canada)
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
12 listed- Investigational Site Number: 8400006 — Washington D.C., District of Columbia (recruiting)
- Investigational Site Number: 8400003 — Atlanta, Georgia (recruiting)
- Investigational Site Number: 8400004 — Atlanta, Georgia (recruiting)
- Investigational Site Number: 8400001 — New York, New York (recruiting)
- Investigational Site Number: 8400002 — Syosset, New York (recruiting)
- Investigational Site Number: 8400005 — Sandy City, Utah (recruiting)
+ 6 sites outside the US on the same record
FAQ about this NCT record
Is NCT07360080 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07360080?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07360080?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary