A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients (AURORA)

ITBMed

Status and phase: Active, not recruiting; Phase 1

Conditions: ALS

Treatments: Biological: TCD601

Study type: Interventional

Funder types: Industry

Identifiers

NCT06453668

TCD601H101

Details and patient eligibility

About

The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TCD601 (siplizumab) in newly diagnosed adult ALS patients.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female patients ≥ 18 to 80 years of age.
• Diagnosis of ALS by revised El Escorial Criteria, at study entry within 24 months of first symptoms.
• Patients on existing ALS treatment must have been on a stable dose for 28 days.

Key Exclusion Criteria:

• Patient with severe systemic infections, current or within the two weeks prior to randomization.
• Subjects who, in the opinion of the investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirements outlined in the protocol.
• Use of other investigational products or treatment in another investigational drug study within 30 days of screening
• Pregnant or nursing (lactating) women.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Treatment

Experimental group

Description:

TCD601 (siplizumab) administered with the contemporary standard of care regimen.

Treatment:

Biological: TCD601