Back to resultsA Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients (STRIDE)
Primary Purpose
Diabetes Mellitus, Type 1
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TCD601
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
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
Sites / Locations
- Karolinska University HosptialRecruiting
- University of Birmingham
- Cambridge University Hospitals NHS Foundation Trust
- University Hospitals of Derby and Burton NHS Foundation Trust
- Guy's and St. Thomas' NHS Foundation Trust
- Swansea Bay University Health Board
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TCD601
Placebo
Arm Description
Administered one of three doses of TCD601 over a 12 week treatment period.
Placebo is administered over a 12 week treatment period.
Outcomes
Primary Outcome Measures
Change from baseline in beta-cell function as compared to placebo at week 52.
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
Assess the incidence and severity of adverse
Number of adverse events compared to placebo at week 52.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06025110
Brief Title
A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients
Acronym
STRIDE
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ITB-Med LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TCD601
Arm Type
Experimental
Arm Description
Administered one of three doses of TCD601 over a 12 week treatment period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo is administered over a 12 week treatment period.
Intervention Type
Biological
Intervention Name(s)
TCD601
Intervention Description
Investigational Product
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Comparator
Primary Outcome Measure Information:
Title
Change from baseline in beta-cell function as compared to placebo at week 52.
Description
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).
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Assess the incidence and severity of adverse
Description
Number of adverse events compared to placebo at week 52.
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Lavasani
Phone
+46 70237 4555
Email
sara.lavasani@itb-med.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kellie Kennon, BSN
Organizational Affiliation
ITB-MED
Official's Role
Study Director
Facility Information:
Facility Name
Karolinska University Hosptial
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coorindator
Facility Name
University of Birmingham
City
Birmingham
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Facility Name
University Hospitals of Derby and Burton NHS Foundation Trust
City
Derby
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Facility Name
Guy's and St. Thomas' NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Facility Name
Swansea Bay University Health Board
City
Swansea
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients
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