This Phase 2 study is a 2-arm, multi-center, double-masked (masking of the participant, care provider and investigator), placebo-controlled, 2:1 randomized trial design in new onset T1D participants (within 100 days of diagnosis). Participants will be administered rezpegaldesleukin/placebo once every 14 days over 26 weeks with an additional 6-month follow-up period.
This protocol will enroll 66 participants within 100 days of T1D diagnosis who will be treated with either rezpegaldesleukin or placebo with subcutaneous injections over 26 weeks, administered once every 14 days. The rezpegaldesleukin/placebo treatment will be administered at the study site. Mixed meal tolerance testing will be done at the screening, baseline visit (V0) and at 3, 6 and 12 months during the study. Once the 26-week treatment period has been completed, participants will continue follow-up visits until 12 months from the baseline visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
66
Rezpegaldesleukin will be dosed at 12 μg/kg for subcutaneous injection. Rezpegaldesleukin will be provided as a 1.5 mg/mL sterile solution in a vial for injection preparation. Study agent injections will be administered in the abdomen, back of the upper arm or the upper thigh of the participant.
Sterile saline for injection. Placebo will be administered in the same volume and as the active comparator to maintain treatment masking.
University of California San Francisco
San Francisco, California, United States
RECRUITINGBarbara Davis Center for Diabetes
Aurora, Colorado, United States
The area under the stimulated C-peptide curve (AUC) Y_MAUC.
The primary outcome of each participant is the mean area under the stimulated C-peptide curve (AUC) over the 2-hour mixed meal glucose tolerance test conducted at the 12-month visit in nmol/L, denoted as Y\_MAUC.
Time frame: 12 Months
Change of MMTT C-peptide mean AUC
This measure will investigate the change of MMTT C-peptide mean AUC between the placebo and rezpegaldesleukin groups applying ANCOVA models and longitudinal mixed-effects models.
Time frame: From enrollment to end of the study at 12 months
Adverse Events
Number of adverse events and severity reported over the course of the study
Time frame: From enrollment till the end of the study at 12 months
Total Daily Insulin Dose per kilogram
Total Daily insulin Dose per kilogram as collected every 3 months once enrolled in the study to 1 year post enrollment.
Time frame: From enrollment and every 3 months to end of study at 12 months.
Change in Quantitative Response (QR) in placebo and treatment groups over time
Investigate the effect on beta cell function at 6 and 12 months in comparison to both contemporaneous placebo-treated participants and historical model-adjusted placebo controls as defined by the Quantitative Response (QR).
Time frame: From enrollment to end of treatment at 6 months and end of study at 12 months.
Change of MMTT Glucose mean AUC
This measure will investigate the change of MMTT Glucose mean AUC between the placebo and rezpegaldesleukin groups applying ANCOVA models and longitudinal mixed-effects models.
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Yale University
New Haven, Connecticut, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
RECRUITINGUniversity of Miami
Miami, Florida, United States
RECRUITINGUSF Diabetes Center
Tampa, Florida, United States
RECRUITINGIndiana University-Riley Hospital for Children
Indianapolis, Indiana, United States
RECRUITINGJoslin Diabetes Center
Boston, Massachusetts, United States
RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGColumbia University
New York, New York, United States
RECRUITING...and 5 more locations
Time frame: From enrollment to end of study at 12 months.
Change of HbA1c
This measure will investigate the change of HbA1c between the placebo and rezpegaldesleukin groups applying ANCOVA models and longitudinal mixed-effects models.
Time frame: From enrollment to end of study at 12 months.