Actively Recruiting
Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-04-02
66
Participants Needed
3
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent or assent with parent or guardian consent if under 18 years old
- Age between 8 and 45 years at consent signing
- Diagnosed with Type 1 Diabetes within 100 days before randomization
- Positive for at least one islet cell autoantibody (e.g., GAD65A, mIAA, IA-2A, ICA, ZnT8A)
- Stimulated C-peptide of at least 0.2 pmol/mL during mixed meal tolerance test done at least 21 days from diabetes diagnosis
- Body weight at least 35 kg and no more than 130 kg for participants 18 years or older
- Body weight between 5th and 98th percentile for age and sex for participants under 18 years
- Willing to comply with intensive diabetes management
- Negative CMV and EBV PCR tests if seronegative, or low viral load if seropositive, within 30 days before randomization
- Meet TrialNet minimum immunization recommendations including timing of vaccinations
- Willing to avoid vaccines other than killed influenza and COVID-19 vaccines during treatment and for 3 months after study drug period
- Females of reproductive potential must agree to avoid pregnancy and undergo pregnancy testing before each visit
- Males of reproductive age must use effective contraception during treatment and for 3 months after last dose
- Age restrictions apply for initial enrollment phases as per safety review protocols
You will not qualify if you...
- Abnormal laboratory values including low neutrophils, lymphocytes, platelets, hemoglobin, or high eosinophils, potassium, sodium, liver enzymes, bilirubin, or creatinine
- Use of non-insulin drugs affecting blood sugar within 7 days before screening or prohibited medications
- Treatment with systemic immunosuppressive agents (except certain corticosteroids) prior to study
- Signs or symptoms of acute infection at randomization or recent infections requiring treatment within 4 weeks
- Evidence or history of tuberculosis or active hepatitis C infection
- Current or past HIV or Hepatitis B infection
- History of malignancy within 5 years except certain skin cancers
- Pregnancy, lactation, or plans to become pregnant during study
- Severe cardiac disease history
- History of organ transplant
- Hypersensitivity to IL-2, PEG, or study drug components
- Major surgery within 12 weeks before screening or planned during study
- Autoimmune diseases other than specified stable conditions
- Abnormal ECG findings indicating heart disease or arrhythmias
- Recent thrombotic events within 6 months
- Untreated significant thyroid disease
- Prior immune-modulating treatments within specified recent periods
- Significant uncontrolled medical conditions affecting participation or safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
2
Vanderbilt University
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
3
University of British Columbia
Vancouver, British Columbia, Canada, V5Z4H4
Not Yet Recruiting
Research Team
J
Jessica Conaty
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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