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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06453668

Acronym

AURORA

Enrollment

Registered

2024-06-12

Start date

2024-04-16

Completion date

2029-11-01

Last updated

2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALS

Keywords

Amyotrophic Lateral Sclerosis, Neuroinflammatory

Brief 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.

Interventions

BIOLOGICALTCD601

Investigational Product

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of the safety of TCD601 in adult patients with ALS	12 Months	Assess the incidence of treatment-emergent Adverse Events \[Safety and Tolerability\]

Secondary

Measure	Time frame	Description
Evaluation of the pharmacokinetics (PK)	12 Months	Siplizumab concentration over time
Correlation of ALS disease status with leucocyte phenotypic profiles	12 Months	The ALS disease status measured by ALSFRS and Kings staging will be compared with the leucocyte phenotypes measured by FACS analysis.
Evaluation of levels of biomarkers	12 Months	Neurofilament light chain levels over time
Length of time from trial entry to tracheostomy / death	12 Months	The time from study enrollment to patient death or tracheostomy will be measured.
Assessment of clinically relevant changes in laboratory measurements	12 Months	Incidence of abnormal laboratory values
Evaluation of pharmacodynamics (PD) of TCD601	12 Months	Lymphocyte counts by subset over time
Assessment of clinically relevant changes in vital signs	12 Months	Incidence of abnormal vital signs

Countries

Sweden

Contacts

CONTACTFredrik Juhlin

fredrik.juhlin@itb-med.com+46 (0)76 394 9872

STUDY_DIRECTORFredrik Julin

ITB-Med LLC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026