A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients
Reason given: The study has been early terminated due to business reasons. This decision is not related to any safety, efficacy, or regulatory concerns.
Key facts
- Where
- Birmingham, Bradford, Cambridge, Dorchester, Dundee, Liverpool, London, Margate, Norwich, Oxford, Salford, and Swansea, United KingdomSee the 13 sites
- Phase
- Phase 2
Where in United Kingdom
- University of BirminghamBirmingham, United KingdomNo longer taking part
- Bradford Teaching Hospitals NHS Foundation TrustBradford, United KingdomNo longer taking part
- Cambridge University Hospitals NHS Foundation TrustCambridge, United KingdomNo longer taking part
- Dorset County Hospital NHS Foundation TrustDorchester, United KingdomNo longer taking part
- Ninewells HospitalDundee, United KingdomNo longer taking part
- Liverpool University Hospitals NHS Foundation TrustLiverpool, United KingdomNo longer taking part
- Guy's and St Thomas' NHS Foundation TrustLondon, United KingdomNo longer taking part
- St. George's University Hospitals NHS Foundation TrustLondon, United KingdomNo longer taking part
- East Kent Hospitals University NHS Foundation TrustMargate, United KingdomNo longer taking part
- Norfolk and Norwich University Hospitals NHS Foundation TrustNorwich, United KingdomNo longer taking part
- Oxford University Hospitals NHS Foundation TrustOxford, United KingdomNo longer taking part
- Northern Care Alliance NHS Foundation TrustSalford, United KingdomNo longer taking part
- Swansea Bay University Health BoardSwansea, United KingdomNo longer taking part
Trial details
- Who runs it
- ITB-Med LLC
- Trial code
- NCT06025110
- Record updated
- 14 August 2025
- Original description
The goal of this study is to determine if treatment with TCD601 improves beta-cell function in adults recently diagnosed with type 1 diabetes compared to placebo.Read full original descriptionShow less
A 12-month, Randomized, Single-blind, Placebo-controlled Exposure-response Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients (STRIDE)
The goal of this study is to determine if treatment with TCD601 improves beta-cell function in adults recently diagnosed with type 1 diabetes compared to placebo.
Inclusion: Able to understand the study requirements and provide written informed consent before any study assessment is performed; Male or female patients ≥ 18 to 45 years of age; A diagnosis of type 1 diabetes.
Exclusion: History of cancer; History of heart disease; Recent infection; Women who are pregnant, lactating, or planning on pregnancy during the study.