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A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients | Clinical Trials | Clareo Health

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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)

NCT06453668•ITB-Med LLC

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.

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.

Locations (3)

Skåne University Hospital Malmö

Malmo, Sweden

Studieenheten Akademiskt Specialistcentrum

Stockholm, Sweden

Umeå University Hospital

Umeå, Sweden

Key Dates

Start Date

April 16, 2024

Primary Completion Date

November 1, 2026

Completion Date

November 1, 2026

Last Updated

January 15, 2026

Enrollment

ESTIMATED participants

Conditions

ALS

Interventions

TCD601

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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