Frexalimab Trial for Type 1 Diabetes
Phase 2
192
about 6.9 years
12–35
14 sites in CA, CO, FL +9
What this study is about
This trial is testing Frexalimab, a drug given by injection, compared to placebo in adults and adolescents with type 1 diabetes who are already on insulin. The goal is to see if Frexalimab helps preserve the body's natural ability to produce insulin.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive Insulin
- 2.Take Frexalimab
- 3.Take Placebo
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
monoclonal antibody, insulin (human)
injection
Primary: Change from baseline to W52 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration
Secondary: Change from baseline to W104 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC, Change from baseline to W52 and W104 in DTSQs Total and item scores (caregivers of all participants 12-17 y.o.), Change from baseline to W52 and W104 in Diabetes Treatment Satisfaction Questionnaires (DTSQs) total and item scores (all participants), Change from baseline to W52 and W104 in PAID immediate and theoretical domain scores (caregivers of all participants 12-17 y.o.), Change from baseline to W52 and W104 in Pediatric Quality of Life (PedsQL) Diabetes Management domain score (all participants), Change from baseline to W52 and W104 in PedsQL Diabetes Symptoms domain score (all participants), Change from baseline to W52 and W104 in Problem Areas In Diabetes (PAID) total score (all participants), Change from baseline to W52 and W104 in insulin dose [IU/kg/day]
Endocrinology