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New treatment option for Type 1 Diabetes Mellitus
Official title Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT07142252
What this study is testing
What is Rezpegaldesleukin?
Rezpegaldesleukin is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for type 1 diabetes mellitus.
Also referred to as NKTR-358.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 26 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 45
You may be able to join if
- Provide informed consent or assent as appropriate and if \< 18 years of age have a parent or legal guardian provide informed consent.
- Age ≥ 8 and ≤ 45 years at the time of signing informed consent and (as applicable) assent A.
- Diagnosis of T1D within 100 days of randomization.
- Positive for at least one islet cell autoantibody; GAD65A, mIAA (if obtained within 10 days of the onset of insulin therapy), IA-2A, ICA, or ZnT8A.
- Stimulated C-peptide of ≥ 0.2 pmol/mL measured during MMTT conducted at least 21 days from diagnosis of diabetes.
You likely can't join if
- One or more screening laboratory values as stated
- Neutrophils \< 1,500 /μL
- Lymphocytes \< 800 /μL
- Platelets \< 100,000 /μL
- Hemoglobin \< 6.2 mmol/L (10.0 g/dL)
- Eosinophils \> 1,000 /μL
See the full eligibility criteria
Who can join
- Provide informed consent or assent as appropriate and if \< 18 years of age have a parent or legal guardian provide informed consent.
- Age ≥ 8 and ≤ 45 years at the time of signing informed consent and (as applicable) assent A.
- Diagnosis of T1D within 100 days of randomization.
- Positive for at least one islet cell autoantibody; GAD65A, mIAA (if obtained within 10 days of the onset of insulin therapy), IA-2A, ICA, or ZnT8A.
- Stimulated C-peptide of ≥ 0.2 pmol/mL measured during MMTT conducted at least 21 days from diagnosis of diabetes.
- Participants ≥ 18 years old to have body weight ≥ 35 kg and ≤ 130kg.
- Participants \ 5th and \<98th percentile for age and sex.
- Willing to comply with intensive diabetes management.
- All CMV and/or EBV seronegative participants must be CMV and EBV PCR negative within 30 days of randomization and may not have had signs or symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within...
- All CMV seropositive participants must be CMV PCR negative and all EBV seropositive participants must have a EBV PCR viral load \< 2,000 IU/mL within 30 days of randomization. All participants may not have had signs or...
- Must meet "TrialNet Eligibility Minimum Immunization Recommendations" found in Appendix A of the MOO.
- Be at least 4 weeks from last live vaccination prior to randomization.
- Participants that are not already immunized against the current year's influenza are required to receive non-live influenza vaccination at least 2 weeks prior to randomization when vaccine for the current or upcoming...
- Be willing to forgo vaccines (other than killed influenza and COVID-19) during the treatment phase and the 3 months after study drug treatment period.
- If a female participant with reproductive potential, must be willing to avoid pregnancy (abstinence or highly effective contraceptive method) through the completion of the study and undergo pregnancy testing prior to...
- Males of reproductive age must use an adequate contraceptive method during the treatment phase and for 3 months following the last dose of study drug. A Only adult participants ≥ 18 years old are permitted to be...
What rules you out
- One or more screening laboratory values as stated
- Neutrophils \< 1,500 /μL
- Lymphocytes \< 800 /μL
- Platelets \< 100,000 /μL
- Hemoglobin \< 6.2 mmol/L (10.0 g/dL)
- Eosinophils \> 1,000 /μL
- Potassium \> 5.5 mmol/L or \< 3.0 mmol/L
- Sodium \> 150 mmol/L or \< 130 mmol/L
- Estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1.73m2
- AST or ALT or ALP \> 2 times the upper limit of normal based on lab reference range
- Total Bilirubin ≥ 1.5 times upper limit of normal unless diagnosed with Gilbert's syndrome
- Serum creatinine \> 2 times the upper limit of normal
- Current or ongoing use of non-insulin pharmaceuticals that affect glycemia within 7 days of the screening visit or any prohibited concomitant medication as listed in section 3.7.
- Concurrent treatment with systemic immunosuppressive agents (including biologics or steroids) - intranasal and inhaled corticosteroids are permitted as well as eye and ear drops containing corticosteroids.
- Have active signs or symptoms of acute infection at the time of randomization.
- Active acute or chronic infection requiring medical treatment (antibiotics, antiviral, antifungal) within 4 weeks of baseline visit unless approved by the Infectious Disease Committee.
- Have evidence of prior or current tuberculosis infection as assessed by Purified Protein Derivative (PPD), interferon gamma release assay (IGRA) or by history.
- Any present malignancies or history of malignancy within the past 5 years, other than a successfully treated nonmelanoma skin cancer.
- Be currently pregnant or lactating or anticipate becoming pregnant during the study.
- History of severe cardiac disease (i.e. myocardial infarction, unstable ischemic heart disease, cerebrovascular accident, stroke, stage 3 or 4 heart failure).
- Have evidence of current or past HIV or Hepatitis B infection.
- Have evidence of active Hepatitis C infection.
- History of organ allograft.
- Hypersensitivity to IL-2, PEG, or any components of the active drug.
- Had major surgery within 12 weeks before the screening visit or anticipates requiring major surgery during the study.
- Has any autoimmune disease other than T1D, stable thyroid, stable asthma, inactive Graves' disease or celiac disease (e.g., rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis...
- Screening 12-lead electrocardiogram (ECG) with findings suggestive/indicative of acute ischemia, clinically important heart disease or clinically important arrhythmias.
- Current or history thrombotic events within six months prior to randomization
- Known or untreated clinically significant hyperthyroidism or hypothyroidism
- Prior treatment within 12 months of randomization with an immune modulating/immune depleting agents, such as teplizumab (TZield), thymoglobulin (ATG) or rituximab.
- Prior treatment within 6 months of randomization with a metabolic therapy intended to alter the disease course of T1D (e.g. teplizumab).
- Has significant and uncontrolled disease/condition in the investigator's opinion that may adversely affect study participation or may compromise the study results or increase participant risk.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 26 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Gainesville, Florida, United States; Miami, Florida, United States; Boston, Massachusetts, United States; New York, New York, United States; Pittsburgh, Pennsylvania, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.