NCT06453668

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: ITB-Med LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to investigate how safe and tolerable the study drug siplizumab is when given to adult patients with ALS. The study will examine how the drug is distributed in the body and what effects it has on different immune cells in the blood and in the fluid surrounding the motor neurons (cerebrospinal fluid). In addition, the study will monitor the progression of ALS and look for any changes related to the disease that may occur during the study.

Conditions

• ALS

Interventions

Type	Name	Description
BIOLOGICAL	TCD601	Investigational Product

Timeline

• Start date: 2024-04-16
• Primary completion: 2029-11-01
• Completion: 2029-11-01
• First posted: 2024-06-12
• Last updated: 2026-03-31

Locations

3 sites across 1 country: Sweden