NCT06453668
Active, not recruiting
Phase 1
A 52-week, Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Trial of Siplizumab in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients (AURORA)
ConditionsALS
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ALS
- Sponsor
- ITB-Med LLC
- Enrollment
- 48
- Locations
- 3
- Primary Endpoint
- Evaluation of the safety of TCD601 in adult patients with ALS
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Evaluation of the safety of TCD601 in adult patients with ALS
Time Frame: 12 Months
Assess the incidence of treatment-emergent Adverse Events \[Safety and Tolerability\]
Secondary Outcomes
- Assessment of clinically relevant changes in vital signs(12 Months)
- Correlation of ALS disease status with leucocyte phenotypic profiles(12 Months)
- Assessment of clinically relevant changes in laboratory measurements(12 Months)
- Evaluation of pharmacodynamics (PD) of TCD601(12 Months)
- Length of time from trial entry to tracheostomy / death(12 Months)
- Evaluation of the pharmacokinetics (PK)(12 Months)
- Evaluation of levels of biomarkers(12 Months)
Study Sites (3)
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