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

ALS Clinical Trial

— AURORA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06453668
• Other study ID #: TCD601H101
• Status: Recruiting
• Phase: Phase 1
• Start date: April 16, 2024
• Est. completion date: November 2026

Study information

• Verified date: April 2024
• Source: ITB-Med LLC
• Contact: Fredrik Juhlin
• Phone: +46 (0)76 394 9872
• Email: fredrik.juhlin[@]itb-med.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• ALS
• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Biological:
• TCD601
Investigational Product

Locations

Country	Name	City	State
Sweden	Skåne University Hospital Malmö	Malmö
Sweden	Studieenheten Akademiskt Specialistcentrum	Stockholm
Sweden	Umeå University Hospital	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
ITB-Med LLC

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the safety of TCD601 in adult patients with ALS	Assess the incidence of treatment-emergent Adverse Events [Safety and Tolerability]	12 Months
Secondary	Evaluation of the pharmacokinetics (PK)	Siplizumab concentration over time	12 Months
Secondary	Correlation of ALS disease status with leucocyte phenotypic profiles		12 Months
Secondary	Evaluation of levels of biomarkers	Neurofilament light chain levels over time	12 Months
Secondary	Length of time from trial entry to tracheostomy / death		12 Months
Secondary	Assessment of clinically relevant changes in laboratory measurements	Incidence of abnormal laboratory values	12 Months
Secondary	Evaluation of pharmacodynamics (PD) of TCD601	Lymphocyte counts by subset over time	12 Months
Secondary	Assessment of clinically relevant changes in vital signs	Incidence of abnormal vital signs	12 Months