A Study of TCD601 (siplizumab) in New Onset Type 1 Diabetes Patients

Phase 2

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: Placebo; Biological: TCD601

• Registration Number: NCT06025110
• Lead Sponsor: ITB-Med LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-23
• Study First Submitted: 2023-08-25
• Study First Submitted QC: 2023-09-01
• Study First Posted: 2023-09-06
• Status Verified: 2024-12
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-05
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• 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 Criteria

• Women who are pregnant, lactating, or planning on pregnancy during the study
• History of cancer
• History of heart disease
• Recent infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo is administered over a 12 week treatment period.
TCD601	TCD601	Administered one of three doses of TCD601 over a 12 week treatment period.

Primary Outcome Measures

Name	Time	Method
Change from baseline in beta-cell function as compared to placebo at week 52.	52 weeks	Assess any changes in beta-cell function at the end of the study (week 52) for patients treated with TCD601 (study drug) compared to subjects treated with placebo (the comparator).

Secondary Outcome Measures

Name	Time	Method
Assess the incidence and severity of adverse	52 weeks	Number of adverse events compared to placebo at week 52.

Trial Locations

Locations (26)

UZ Brussel; 🇧🇪 Brussel, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Azienda Ospedaliero-Universitaria Renato Dulbecco; 🇮🇹 Catanzaro, Italy

San Raffaele Hospital; 🇮🇹 Milan, Italy

Luigi Sacco Hospital; 🇮🇹 Milan, Italy

University of Siena; 🇮🇹 Siena, Italy

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitari de Bellvitge; 🇪🇸 Barcelona, Spain

Hospital Universitari de Girona Dr. Josep Trueta; 🇪🇸 Girona, Spain

Hospital General de Segovia; 🇪🇸 Segovia, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Clinico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Karolinska University Hosptial; 🇸🇪 Stockholm, Sweden

Dorset County Hospital NHS Foundation Trust; 🇬🇧 Dorchester, Dorset, United Kingdom

Liverpool University Hospitals NHS Foundation Trust; 🇬🇧 Liverpool, Merseyside, United Kingdom

University of Birmingham; 🇬🇧 Birmingham, United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust; 🇬🇧 Bradford, United Kingdom

Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, United Kingdom

Ninewells Hospital; 🇬🇧 Dundee, United Kingdom

St George's University Hospitals NHS Foundation Trust; 🇬🇧 London, United Kingdom

Guy's and St. Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom

East Kent Hospitals University NHS Foundation Trust; 🇬🇧 Margate, United Kingdom

Norfolk and Norwich University Hospitals NHS Foundation Trust; 🇬🇧 Norwich, United Kingdom

Oxford University Hospitals NHS Foundation Trust; 🇬🇧 Oxford, United Kingdom

Northern Care Alliance NHS Foundation Trust; 🇬🇧 Salford, United Kingdom

Swansea Bay University Health Board; 🇬🇧 Swansea, United Kingdom