The trial is taking place at:
U

University of Pisa | Department of Dermatology

Veeva-enabled site

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

I

ITBMed

Status and phase

Enrolling
Phase 2

Conditions

Diabetes Mellitus, Type 1

Treatments

Biological: TCD601
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06025110
TCD601F201

Details and patient eligibility

About

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.

Enrollment

96 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

96 participants in 2 patient groups, including a placebo group

TCD601
Experimental group
Description:
Administered one of three doses of TCD601 over a 12 week treatment period.
Treatment:
Biological: TCD601
Placebo
Placebo Comparator group
Description:
Placebo is administered over a 12 week treatment period.
Treatment:
Other: Placebo

Trial contacts and locations

38

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Central trial contact

Sara Lavasani

Data sourced from clinicaltrials.gov

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