Immune tweak shows promise for ALS in early trial
NCT ID NCT02059759
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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36 people
The number who actually took part.
- Start date
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Sep 2015
- Finished
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May 2016
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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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Other studies related to the condition(s) this trial covers.
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