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

August 11, 2025 updated by: ITB-Med LLC

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, 1090
        • UZ Brussel
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Italy
      • Catanzaro, Italy, 88100
        • Azienda Ospedaliero-Universitaria Renato Dulbecco
      • Milan, Italy, 20132
        • San Raffaele Hospital
      • Milan, Italy, 20157
        • Luigi Sacco Hospital
      • Siena, Italy, 53100
        • University of Siena
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge
      • Girona, Spain, 17007
        • Hospital Universitari de Girona Dr. Josep Trueta
      • Segovia, Spain, 40002
        • Hospital General de Segovia
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valladolid, Spain, 47003
        • Hospital Clínico Universitario de Valladolid
  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hosptial
  • United Kingdom
      • Birmingham, United Kingdom
        • University of Birmingham
      • Bradford, United Kingdom, BD9 6DA
        • Bradford Teaching Hospitals NHS Foundation Trust
      • Cambridge, United Kingdom
        • Cambridge University Hospitals NHS Foundation Trust
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • London, United Kingdom, SW17 0QT
        • St George's University Hospitals NHS Foundation Trust
      • London, United Kingdom
        • Guy's and St. Thomas' NHS Foundation Trust
      • Margate, United Kingdom, CT9 4AN
        • East Kent Hospitals University NHS Foundation Trust
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospitals Nhs Foundation Trust
      • Oxford, United Kingdom, OX3 7LE
        • Oxford University Hospitals NHS Foundation Trust
      • Salford, United Kingdom, M6 8HD
        • Northern Care Alliance NHS Foundation Trust
      • Swansea, United Kingdom
        • Swansea Bay University Health Board
    • Dorset
      • Dorchester, Dorset, United Kingdom, DT1 2JY
        • Dorset County Hospital NHS Foundation Trust
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L7 8YE
        • Liverpool University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TCD601
Administered one of three doses of TCD601 over a 12 week treatment period.
Biological: TCD601
Investigational Product
Placebo Comparator: Placebo
Placebo is administered over a 12 week treatment period.
Other: Placebo
Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in beta-cell function as compared to placebo at week 52.
Time Frame: 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).
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the incidence and severity of adverse
Time Frame: 52 weeks
Number of adverse events compared to placebo at week 52.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ITB-Med LLC

Investigators

  • Study Director: Fredrik Juhlin, ITB-MED

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2023

Primary Completion (Actual)

July 24, 2025

Study Completion (Actual)

July 24, 2025

Study Registration Dates

First Submitted

August 25, 2023

First Submitted That Met QC Criteria

September 1, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCD601F201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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