RecruitingPhase 1NCT06453668

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

A 52-week, Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Trial of Siplizumab in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients (AURORA)

Sponsor

ITB-Med LLC

Enrollment

48 participants

Start Date

Apr 16, 2024

Study Type

INTERVENTIONAL

Conditions

ALS

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

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.

Exclusion Criteria4

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.

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