Testing Rezpegaldesleukin against a placebo for type 1 diabetes mellitus
Official title: Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus
Interventions
Rezpegaldesleukin
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.
Placebo
Sterile saline for injection. Placebo will be administered in the same volume and as the active comparator to maintain treatment masking.
Canadian Sites (1)
University of British Columbia
Vancouver, British Columbia, Canada
Eligibility Criteria
See who this study is looking for49 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥ 8 and ≤ 45 years at the time of signing informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → and (as applicable) assent A.
- +A Only adult participants ≥ 18 years old are permitted to be included in the first 18 enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → participants in this study. Participants ≥ 12 and \< 18 years of age are only permitted to screen for this study if the safety review of the first 18 adult participants is assessed favorably by the TrialNet DSMBData Safety Monitoring Board (DSMB)An independent group that reviews safety data while a study is running.Read more → in consultation with Nektar Safety Group. Once an additional 17 participants ages 12 to 45, including at least 9 participants aged 12-17, enroll and complete through the 6-month visit and have the safety review assessed favorably by the TrialNet DSMB in consultation with Nektar Safety Group, then the trial is permitted to screen and enroll the remaining 31 enrollees ≥ 8 and ≤ 45 years old. If data at either juncture do not support expansion into the pediatric ages, the trial will enroll the remaining participants to reach the target sample size with the currently approved age thresholds. See protocolProtocolThe detailed plan a study must follow.Read more → sections 2.5 and 3.5 for additional details.
- +Provide informed consent or assent as appropriate and if \< 18 years of age have a parent or legal guardian provide informed consent.
- +Diagnosis of T1D within 100 days of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +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 \< 18 years old to have body weight \> 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 30 days of randomization.
- +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 symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within 30 days of randomization.
- +Must meet "TrialNet EligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → 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 flu season is available.
- +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 each study visit.
- +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.
Exclusion
- −Hypersensitivity to IL-2, PEG, or any components of the active drug.
- −Have evidence of current or past HIV or Hepatitis B infection.
- −Have evidence of active Hepatitis C infection.
- −One or more screeningScreeningThe checks done before joining, to see whether a study fits.Read more → 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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −Active acute or chronic infection requiring medical treatment (antibiotics, antiviral, antifungal) within 4 weeks of baseline visitBaselineYour starting measurements, taken before treatment begins.Read more → 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.
- −History of severe cardiac disease (i.e. myocardial infarction, unstable ischemic heart disease, cerebrovascular accident, stroke, stage 3 or 4 heart failure).
- −History of organ allograft.
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion that may adversely affect study participation or may compromise the study results or increase participant risk.
- −Be currently pregnant or lactating or anticipate becoming pregnant during the study.
- −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, ankylosing spondylitis, multiple sclerosis, systemic lupus erythematous) or has any other disease that may be affected by immunotherapy.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: Rezpegaldesleukin, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 8 years to 45 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 66 people.
The study is currently expected to finish around May 2028.
The main measurement is taken over: 12 Months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
The area under the stimulated C-peptide curve (AUC) Y_MAUC — measured over 12 Months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07142252 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About RezpegaldesleukinDrug
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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Sterile saline for injection. Placebo will be administered in the same volume and as the active comparator to maintain treatment masking.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 8 years to 45 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 8 years to 45 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 12 Months.
The study as a whole is currently expected to finish around 2028-05-25.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 66 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Vancouver, British Columbia, Canada; Minneapolis, Minnesota, United States; New York, New York, United States; Seattle, Washington, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (3)
University of Minnesota
Minneapolis, Minnesota, United States
Columbia University
New York, New York, United States
Benaroya Research Institute
Seattle, Washington, United States
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.