Actively Recruiting
A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients
Led by ITB-Med LLC · Updated on 2026-03-31
48
Participants Needed
3
Research Sites
289 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TCD601 (siplizumab) in newly diagnosed adult ALS patients.
CONDITIONS
Official Title
A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 80 years
- Diagnosis of ALS by revised El Escorial Criteria within 24 months of first symptoms
- Patients on existing ALS treatment must have been on a stable dose for at least 28 days
You will not qualify if you...
- Severe systemic infections currently or within two weeks prior to enrollment
- Unable or unwilling to give informed consent or adhere to study requirements
- Use of other investigational drugs within 30 days before screening
- Pregnant or nursing (lactating) women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Skåne University Hospital Malmö
Malmö, Sweden, 205 02
Actively Recruiting
2
Studieenheten Akademiskt Specialistcentrum
Stockholm, Sweden, 171 77
Actively Recruiting
3
Umeå University Hospital
Umeå, Sweden, 901 85
Actively Recruiting
Research Team
F
Fredrik Juhlin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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