{ "data": { "asOf": "2026-10-30T22:27:51.771Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "isrctn": 1 }, "canonicalTrial": { "canonicalId": "ISRCTN85031369", "title": "Balancing \"bad\" and \"good\" immune cells: testing a novel method for monitoring an immunosuppression strategy in people with Type 1 diabetes", "scientificTitle": "Treg-sparing co-stimulation blockade: testing a novel method for monitoring an immunosuppression strategy in people with Type 1 diabetes", "status": "active", "studyType": "interventional", "phase": [], "conditions": [ "Type 1 diabetes" ], "interventions": [ { "type": "Other", "description": "Group 1: Abatacept at weeks 0, 2, 4 and 8 in combination with Interleukin-2 only for 16 weeks starting at week 0\nGroup 2: Abatacept only at week 0, 2, 4 and 8\n\nAbatacept\nParticipants will receive 10 mg/kg intravenously (maximum 1000 mg per dose) at 0, 2, 4 and 8 weeks. \n\nInterleukin-2 \n0.45 x 10e6 IU/m2 of body surface will be given twice weekly (every 3+/-1 days) subcutaneously." } ], "sponsor": null, "locations": [ { "country": "United Kingdom" }, { "country": "England" }, { "country": "Wales" } ], "outcomes": { "other": [], "primary": [], "secondary": [] }, "eligibility": { "gender": "All", "exclusion": "1. Females who are pregnant, breastfeeding, anticipating being pregnant within 14 weeks of the last study drug administration or not using adequate forms of contraception. Males whose partners are WOCBP and not using an adequate form of contraception. The following birth control methods should be used (considered highly effective with a failure rate of less than 1% per year when used consistently and correctly): \n1.1. Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, transdermal \n1.2. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable\n1.3. Intrauterine device (IUD)\n1.4. Intrauterine hormone-releasing system (IUS)\n1.5. Bilateral tubal occlusion\n1.6. Vasectomised partner (provided that the partner is the sole sexual partner of the trial participant, and that medical assessment of azoospermia has been confirmed)\n1.7. Sexual abstinence (defined as refraining from heterosexual intercourse during the duration of the trial) \n2. Use of immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to randomisation and any monoclonal antibody therapy given for any indication\n3. Immunisations with live vaccines within 1 month from screening\n4. Immunodeficient or have clinically significant lymphopaenia\n5. Patients with White Blood Count (WBC) <4.000/mm3; platelets < 100.000/mm3; haematocrit (HCT) <30%.\n6. Have an active infection at the time of randomisation\n7. Have positive Purified Protein Derivative (PPD) or IGRA (interferon-gamma release assay) result or history of previously treated tuberculosis\n8. Have serological evidence of current or past HIV, Hepatitis B (positive for Hepatitis B core antibody or surface antigen), or Hepatitis C infection\n9. Have a history of malignancies\n10. Have multiple sclerosis\n11. Patients with a significant history or current evidence of severe cardiac disease\n12. Patients with pre-existing severe major organ dysfunction\n13. Patients with seizure disorders\n14. Patients with organ allografts\n15. Patients with pre-existing auto-immune disease except for Type 1 diabetes and primary hypothyroidism\n16. Patients with serum bilirubin (except for Gilbert’s syndrome) and creatinine outside normal range\n17. Weight <50 kg\n18. Any other medical condition, which, in the opinion of investigators, could affect the safety of the subject’s participation\n19. Recent subject’s involvement in other research studies which, in the opinion of investigators, may adversely affect the safety of the subjects or the results of the study\n20 .HbA1c >90 mmol/mol measured in the last 3 months", "inclusion": "1. Aged 18-50 years\n2. Diagnosis of Type 1 diabetes in the last 5 years, but not earlier than 3 months\n3. Written and witnessed informed consent to participate\n4. 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