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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. Identifier: NCT06025110
Recruitment Status : Recruiting
First Posted : September 6, 2023
Last Update Posted : April 11, 2024
Information provided by (Responsible Party):

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

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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

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

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT06025110

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Contact: Sara Lavasani +46 70237 4555

Show Show 38 study locations
Sponsors and Collaborators
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Study Director: Kellie Kennon, BSN ITB-MED
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Responsible Party: ITB-Med LLC Identifier: NCT06025110    
Other Study ID Numbers: TCD601F201
First Posted: September 6, 2023    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
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