NCT06453668 A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients
| NCT ID | NCT06453668 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | ITB-Med LLC |
| Condition | ALS |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-04-16 |
| Primary Completion | 2029-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2024-04-16 with a primary completion date of 2029-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Fredrik Julin
STUDY DIRECTOR
ITB-Med LLC
Frequently Asked Questions
Who can join the NCT06453668 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying ALS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06453668 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06453668 currently recruiting?
Yes, NCT06453668 is actively recruiting participants. Contact the research team at fredrik.juhlin@itb-med.com for enrollment information.
Where is the NCT06453668 trial being conducted?
This trial is being conducted at Malmö, Sweden, Stockholm, Sweden, Umeå, Sweden.
Who is sponsoring the NCT06453668 clinical trial?
NCT06453668 is sponsored by ITB-Med LLC. The principal investigator is Fredrik Julin at ITB-Med LLC. The trial plans to enroll 48 participants.
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