Health TrialsbyHealthPanel

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

ConditionALS
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorITB-Med LLC

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • TCD601

    Biological/Vaccine

    Investigational Product

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evaluation of the safety of TCD601 in adult patients with ALS

Assess the incidence of treatment-emergent Adverse Events \[Safety and Tolerability\]

Time frame
12 Months

Secondary outcomes

1

Evaluation of the pharmacokinetics (PK)

Siplizumab concentration over time

Time frame
12 Months
2

Correlation of ALS disease status with leucocyte phenotypic profiles

The ALS disease status measured by ALSFRS and Kings staging will be compared with the leucocyte phenotypes measured by FACS analysis.

Time frame
12 Months
3

Evaluation of levels of biomarkers

Neurofilament light chain levels over time

Time frame
12 Months
4

Length of time from trial entry to tracheostomy / death

The time from study enrollment to patient death or tracheostomy will be measured.

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ITB-Med LLC

Lead sponsor

Source ClinicalTrials.gov
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