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

Sponsor

ITB-Med LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06025110

Collaborator

(none)

Enrollment

Location

Arms

23.3

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 23, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

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

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

Primary Outcome Measures

Change from baseline in beta-cell function as compared to placebo at week 52. [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

Assess the incidence and severity of adverse [52 weeks]
Number of adverse events compared to placebo at week 52.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Karolinska University Hosptial	Stockholm	Huddinge	Sweden	14157

Sponsors and Collaborators

ITB-Med LLC

Investigators

Study Director: Kellie Kennon, BSN, ITB-MED

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ITB-Med LLC

ClinicalTrials.gov Identifier:

NCT06025110

Other Study ID Numbers:

TCD601F201

First Posted:

Sep 6, 2023

Last Update Posted:

Sep 6, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Sep 6, 2023