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New drug siplizumab tested in ALS patients – early trial begins

NCT ID NCT06453668

Disease control Sponsor: ITB-Med LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This early-stage trial tests the safety of siplizumab, a drug that may calm the immune system, in 48 adults newly diagnosed with ALS. Researchers will monitor side effects and how the drug moves through the body. The goal is to see if it is safe enough for larger studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
siplizumab (TCD601)
What this could lead to
If safe and effective, siplizumab could slow ALS progression by targeting the immune system, offering a new treatment option.
What could go wrong
This is an early Phase 1 trial with only 48 people, focused on safety. It may not show benefit, and side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

7 people

The number who actually took part.

Started

Apr 2024

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ALS

Contacts and locations

Locations

  • Skåne University Hospital Malmö

    Malmö, 205 02, Sweden

  • Studieenheten Akademiskt Specialistcentrum

    Stockholm, 171 77, Sweden

  • Umeå University Hospital

    Umeå, 901 85, Sweden

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