Clinical trial

A 12-month, Randomized, Single-blind, Placebo-controlled Exposure-response Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients (STRIDE)

Name

TCD601F201

Description

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.

Trial arms

Trial start

2023-01-23

Estimated PCD

2025-01-01

Trial end

2025-01-01

Status

Recruiting

Phase

Early phase I

Treatment

TCD601

Investigational Product

Arms:

TCD601

Placebo

Comparator

Arms:

Placebo

Size

Primary endpoint

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

52 weeks

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 96, 'type': 'ESTIMATED'}}

Updated at

2024-04-11

1 organization

1 product

2 indications

Organization

Product

Indication

Indication