ISRCTN14274380已完成2 期
Phase II multi-centre, double-blind, randomised trial of ustekinumab in adolescents with new-onset type 1 diabetes
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34663658/ (added 15/08/2022) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39079992/ (added 31/07/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 10/12/2019:
- •1. Clinical diagnosis of immune-mediated Type 1 diabetes mellitus as defined by American Diabetes Association
- •2. Commenced on insulin within 1 month of clinical diagnosis (defined as confirmed raised blood sugar (ADA criteria), not symptoms alone).
- •3. An interval of =100 days between the confirmed diagnosis (defined as first insulin dose) and the first dose of the IMP
- •4. Written and witnessed informed consent/assent to participate
- •5. Male or female, aged 12-18 years inclusive at the time of randomisation
- •6. Evidence of residual functioning beta-cells (serum C-peptide level > 0.2nmol/L in the MMTT test)
- •7. Positive for at least one islet autoantibody (GAD, IA-2, ZnT8)
- •8. Body weight < 100 kg
- •9. Willing to record all insulin doses and blood glucose levels required for monitoring during the study, including reporting any hypoglycaemic events.
- •10. Willing to provide dried blood spot (DBS) samples.
- •11. Willing to wear the FreeStyle Libre Flash Glucose Monitor (FGM) device at least two weeks prior to a study visit.
- •12. Willing to complete a diary and quality of life questionnaires.
- •13. Willing to consent to remote follow up via health records and telephone contact
- •14. Female participants have a negative urine test for pregnancy; all sexually active participants must agree to use adequate contraception (hormonal based contraception, double barrier contraception, abstinence) until 4 months following the date of their final treatment of IMP
- •Previous inclusion criteria:
- •1. Clinical diagnosis of immune-mediated Type 1 diabetes mellitus as defined by American Diabetes Association
- •2. An interval of =100 days between the diagnosis (defined as first insulin dose) and the first dose of the IMP
- •3. Commenced on insulin within 1 month of diagnosis
- •4. Written and witnessed informed consent/assent to participate
- •5. Male or female, aged 12-18 years inclusive at the time of randomisation
- •6. Evidence of residual functioning beta-cells (serum C-peptide level > 0.2nmol/L in the MMTT test)
- •7. Positive for at least one islet autoantibody (GAD, IA-2, ZnT8)
- •8. Body weight < 100 kg
- •9. Willing to record all insulin doses and blood glucose levels required for monitoring during the study, including reporting any hypoglycaemic events
- •10. Willing to consent to remote follow up via health records and telephone contact
- •11. Female participants have a negative urine test for pregnancy; all sexually active participants must agree to use adequate contraception (hormonal based contraception, double barrier contraception, abstinence) until 4 months following the date of their final treatment of IMP
排除标准
- •Current exclusion criteria as of 10/12/2019:
- •1. Breastfeeding, pregnancy or unwillingness to comply with contraceptive advice and regular pregnancy testing throughout the trial
- •2. Prior exposure to Ustekinumab within 3 months of the first dose of IMP
- •3. Use of more than 10 mg prednisolone daily (or equivalent) for >5 days within 3 months of the first dose of IMP. Note: intranasal, inhaled and topical corticosteroid medications are permitted at recommended doses. Use of systemic corticosteroids during the trial should be avoided unless such treatment is medically necessary and alternative treatments are not considered safe or effective
- •4. Prior exposure to any anti-lymphocyte monoclonal antibody, such as anti-CD20, anti-thymocyte globulin (ATG), Rituximab (Rituxan®), or Alemtuzumab (Campath®)
- •5. Use of immunosuppressive or immunomodulatory therapies, including systemic steroids (e.g., methotrexate, cyclosporine, or anti-TNF agents) within 30 days prior to receiving the first dose and/or intent on using any monoclonal antibody therapy given for any indication for the duration (including follow up) of the trial
- •6. Use of any hypoglycaemia agents other than insulin, for more than 6 weeks, at any time prior to trial entry, including SGLT2 inhibitors.
- •7. Use of inhaled insulin
- •8. Known alcohol abuse, drug abuse
- •9. Evidence of active Hepatitis B, Hepatitis C, HIV or considered by the investigator to be at high risk for HIV infection
- •10. Significant systemic infection during the 6 weeks before the first dose of the IMP (e.g. infection requiring hospitalisation, major surgery, requiring IV antibiotic treatment). Other infections e.g. glandular fever, bronchitis, sinusitis, cellulitis, or urinary tract infections must be assessed on a case by case basis by the investigator to assess whether they are serious enough to warrant exclusion or delay to inclusion
- •11. History of current or past active tuberculosis (TB) infection and no latent tuberculosis according to the British Thoracic Society recommendations [27]. Active TB will be assessed using a mandatory chest x-ray and one of the following:
- •a) a blood test e.g. T-spot (preferred), interferon gamma release assay (IGRA), quantiferon test
- •b) the Mantoux skin test.
- •A positive result from any TB test will exclude the subject from the study and the subject and their medical care team will be informed. An intermediate result from blood sample testing will not exclude the participant from randomisation if the chest x-ray is negative. The blood test for TB only needs to be repeated if there is a change in the perceived clinical risk of TB
- •12. Participants should not have had live immunisations (flu and others) for 1 month prior to trial entry and should not receive any during their time in the trial. Note that most injected (as opposed to nasal) influenza vaccines are not live vaccines and are permitted
- •13. Previous use of any other investigational drug within the 3 months prior to the first dose and/or intent on using any investigational drug for the duration (including follow up) of the trial
- •14. Recent (within 3 months) participant’s involvement in other research studies which, in the opinion of investigators, may adversely affect the safety of the participants or the results of the study
- •15. Significantly abnormal laboratory results during the screening period, other than those due to T1D
- •16. Prior allergic reaction, including anaphylaxis, to any component of the IMP product
- •17. Prior allergic re
研究者
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