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

ITBMed

Status and phase: Active, not recruiting; Phase 2

Conditions: Diabetes Mellitus, Type 1

Treatments: Other: Placebo; Biological: TCD601

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

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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