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

Phase 2TerminatedNCT06025110

ITB-Med LLC9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

TCD601BIOLOGICAL

Investigational Product

PlaceboOTHER

Comparator

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (26)

UZ Brussel

Brussels, Belgium

Outcomes

Primary Outcomes

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).

Time frame: 52 weeks

Secondary Outcomes

Assess the incidence and severity of adverse

Number of adverse events compared to placebo at week 52.

Time frame: 52 weeks

Data from ClinicalTrials.gov

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