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Immune tweak shows promise for ALS in early trial

NCT ID NCT02059759

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase II study tested whether low doses of interleukin-2 (IL-2) can safely boost regulatory T cells in people with amyotrophic lateral sclerosis (ALS). 36 participants received either IL-2 or a placebo for five days. The goal was to see if this immune-modulating approach could help control the disease, not cure it.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

36 people

The number who actually took part.

Start date

Sep 2015

Finished

May 2016

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 75 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.

Inclusion Criteria: * The patient has been correctly informed * The patient must have given his/her informed and signed consent. * The patient must be insured or beneficiary of a health insurance plan. * The patient is at least 18 years old and less than 75 years old * Probable, or laboratory-supported probable or definite ALS as defined by El Escorial Revised ALS diagnostic criteria (according to Airlie House Conference 1988) * Stable on riluzole treatment for more than 3 months with liver function test results \< 2ULN * Disease duration ≤ 5 years * Vital capacity ≥ 70% of normal * Ability to swallow without the requirement for nasogastric or PEG feeding * Agreement for patient to use an adequate method of contraception throughout the study and for 2 weeks after post study visit * The patient is available and willing to participate in seven study visits occurring at the CHU within the next six months Exclusion Criteria: * The patient is participating in another interventional study * Within the past three months, the patient has participated in another interventional * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection * The patient is an adult under guardianship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * Other life threatening disease * Presence of contra-indicated concomitant treatments or with potential neuroprotective benefit (see section 11.2 of the protocol) * Presence of tracheostomy or non-invasive ventilation * Use of Percutaneous endoscopic gastrostomy (PEG) or nasogastric tube * Presence of clinical infection (treated or untreated) * Positive serology for CMV, EBV (confirmed by viral load), or HIV * Vaccination within 8 weeks prior to first experimental dosing * Other disease precluding functional assessments * Cancer within the past 5 years (except stable non-metastatic basal cell skin carcinoma or in situ carcinoma of the cervix) * Severe cardiac or pulmonary disease * Documented auto-immune disorders except asymptomatic Hashimoto thyroiditis * Women of child bearing age without contraception or pregnant or breast feeding * Any clinically significant laboratory abnormality (excepting cholesterol, triglyceride and glucose)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • CHRU de Montpellier - Hôpital Gui de Chauliac

    Montpellier, 34295, France

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