Clinical trial NCT06025110: A Study of TCD601 (siplizumab) in New Onset Type 1 Diabetes Patients
Official title: A 12-month, Randomized, Single-blind, Placebo-controlled Exposure-response Study of TCD601 (siplizumab) in New Onset Type 1 Diabetes Patients (STRIDE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: ITB-Med LLC
Sponsor class: INDUSTRY
First posted: 2023-09-06
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in beta-cell function as compared to placebo at week 52.
timeFrame: 52 weeks
Secondary outcomes:
measure: Assess the incidence and severity of adverse
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
city: Leuven
country: Belgium
facility: UZ Leuven
city: Catanzaro
country: Italy
facility: Azienda Ospedaliero-Universitaria Renato Dulbecco
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Milan
country: Italy
facility: Luigi Sacco Hospital
city: Siena
country: Italy
facility: University of Siena
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Stockholm
country: Sweden
facility: Karolinska University Hosptial
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital NHS Foundation Trust
state: Dorset
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
state: Merseyside
city: Birmingham
country: United Kingdom
facility: University of Birmingham
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's and St. Thomas' NHS Foundation Trust
city: Margate
country: United Kingdom
facility: East Kent Hospitals University NHS Foundation Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Salford
country: United Kingdom
facility: Northern Care Alliance NHS Foundation Trust
city: Swansea
country: United Kingdom
facility: Swansea Bay University Health Board
Study officials:
affiliation: ITB-MED
name: Fredrik Juhlin
role: STUDY_DIRECTOR
References: