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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06025110
Recruitment Status : Recruiting
First Posted : September 6, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
ITB-Med LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Biological: TCD601 Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A 12-month, Randomized, Single-blind, Placebo-controlled Exposure-response Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients (STRIDE)
Actual Study Start Date : January 23, 2023
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Assess the incidence and severity of adverse [ Time Frame: 52 weeks ]
    Number of adverse events compared to placebo at week 52.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06025110


Contacts
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Contact: Elma Redzic +46 70946 4048 elma.redzic@itb-med.com

Locations
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Sweden
Karolinska University Hosptial Recruiting
Stockholm, Sweden
Contact: Research Coorindator         
United Kingdom
University of Birmingham Not yet recruiting
Birmingham, United Kingdom
Contact: Research Coordinator         
Cambridge University Hospitals NHS Foundation Trust Not yet recruiting
Cambridge, United Kingdom
Contact: Research Coordinator         
University Hospitals of Derby and Burton NHS Foundation Trust Not yet recruiting
Derby, United Kingdom
Contact: Research Coordinator         
Guy's and St. Thomas' NHS Foundation Trust Not yet recruiting
London, United Kingdom
Contact: Research Coordinator         
Swansea Bay University Health Board Not yet recruiting
Swansea, United Kingdom
Contact: Research Coordinator         
Sponsors and Collaborators
ITB-Med LLC
Investigators
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Study Director: Kellie Kennon, BSN ITB-MED
More Information
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Responsible Party: ITB-Med LLC
ClinicalTrials.gov Identifier: NCT06025110    
Other Study ID Numbers: TCD601F201
First Posted: September 6, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases