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

NCT ID: NCT06025110

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-23

Study Completion Date

2025-07-24

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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TCD601

Administered one of three doses of TCD601 over a 12 week treatment period.

Group Type EXPERIMENTAL

TCD601

Intervention Type BIOLOGICAL

Investigational Product

Placebo

Placebo is administered over a 12 week treatment period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Comparator

Interventions

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TCD601

Investigational Product

Intervention Type BIOLOGICAL

Placebo

Comparator

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ITB-Med LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fredrik Juhlin

Role: STUDY_DIRECTOR

ITB-MED

Locations

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UZ Brussel

Brussels, , Belgium

Site Status

UZ Leuven

Leuven, , Belgium

Site Status

Azienda Ospedaliero-Universitaria Renato Dulbecco

Catanzaro, , Italy

Site Status

San Raffaele Hospital

Milan, , Italy

Site Status

Luigi Sacco Hospital

Milan, , Italy

Site Status

University of Siena

Siena, , Italy

Site Status

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status

Hospital Universitari de Bellvitge

Barcelona, , Spain

Site Status

Hospital Universitari de Girona Dr. Josep Trueta

Girona, , Spain

Site Status

Hospital General de Segovia

Segovia, , Spain

Site Status

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status

Hospital Clinico Universitario de Valladolid

Valladolid, , Spain

Site Status

Karolinska University Hosptial

Stockholm, , Sweden

Site Status

Dorset County Hospital NHS Foundation Trust

Dorchester, Dorset, United Kingdom

Site Status

Liverpool University Hospitals NHS Foundation Trust

Liverpool, Merseyside, United Kingdom

Site Status

University of Birmingham

Birmingham, , United Kingdom

Site Status

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, , United Kingdom

Site Status

Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

Site Status

Ninewells Hospital

Dundee, , United Kingdom

Site Status

St George's University Hospitals NHS Foundation Trust

London, , United Kingdom

Site Status

Guy's and St. Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status

East Kent Hospitals University NHS Foundation Trust

Margate, , United Kingdom

Site Status

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, , United Kingdom

Site Status

Oxford University Hospitals NHS Foundation Trust

Oxford, , United Kingdom

Site Status

Northern Care Alliance NHS Foundation Trust

Salford, , United Kingdom

Site Status

Swansea Bay University Health Board

Swansea, , United Kingdom

Site Status

Countries

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Belgium Italy Spain Sweden United Kingdom

Other Identifiers

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TCD601F201

Identifier Type: -

Identifier Source: org_study_id

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