A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients
AURORA
A 52-week, Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Trial of Siplizumab in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients (AURORA)
1 other identifier
interventional
48
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2024
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2024
CompletedFirst Submitted
Initial submission to the registry
May 6, 2024
CompletedFirst Posted
Study publicly available on registry
June 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2029
March 31, 2026
September 1, 2025
5.5 years
May 6, 2024
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Evaluation of the pharmacokinetics (PK)
12 Months
Correlation of ALS disease status with leucocyte phenotypic profiles
12 Months
Evaluation of levels of biomarkers
12 Months
Length of time from trial entry to tracheostomy / death
12 Months
Assessment of clinically relevant changes in laboratory measurements
12 Months
- +2 more secondary outcomes
Study Arms (1)
Treatment
EXPERIMENTALTCD601 (siplizumab) administered with the contemporary standard of care regimen.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ITB-Med LLClead
Study Sites (3)
Skåne University Hospital Malmö
Malmo, 205 02, Sweden
Studieenheten Akademiskt Specialistcentrum
Stockholm, 171 77, Sweden
Umeå University Hospital
Umeå, 901 85, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fredrik Julin
ITB-Med LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2024
First Posted
June 12, 2024
Study Start
April 16, 2024
Primary Completion (Estimated)
November 1, 2029
Study Completion (Estimated)
November 1, 2029
Last Updated
March 31, 2026
Record last verified: 2025-09