Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
TCD601H101
Description
The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TCD601 (siplizumab) in newly diagnosed adult ALS patients.
Trial arms
Trial start
2024-04-16
Estimated PCD
2026-11-01
Trial end
2026-11-01
Status
Recruiting
Phase
Early phase I
Treatment
TCD601
Investigational Product
Arms:
Treatment
Other names:
siplizumab
Size
48
Primary endpoint
Evaluation of the safety of TCD601 in adult patients with ALS
12 Months
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}
Updated at
2024-06-12

1 organization

1 product

1 indication

Organization
ITB-Med
Product
TCD601
Indication
Amyotrophic Lateral Sclerosis (ALS)