Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT02059759
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2014-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C082598', 'term': 'aldesleukin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2016-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2014-02-07', 'studyFirstSubmitQcDate': '2014-02-07', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age (years)', 'timeFrame': 'Baseline'}, {'measure': 'Sex (male/female)', 'timeFrame': 'Baseline'}, {'measure': 'Body mass index (kg/m^2)', 'timeFrame': 'Baseline'}, {'measure': 'Disease duration from date of first symptoms (fatigue, weakness)', 'timeFrame': 'Baseline'}, {'measure': "The patient's current Riluzole posology", 'timeFrame': 'Baseline to week 25'}, {'measure': "The patient's currentposology for other concomitant treatments", 'timeFrame': 'Baseline to week 25'}, {'measure': 'Description of concomitant treatments, if any', 'timeFrame': 'Throughout study, up to 25 weeks'}, {'measure': 'Routine serology results dating to within the last 30 days: HIV-1 (positive/negative ?)', 'timeFrame': 'Baseline'}, {'measure': 'Routine serology results dating to within the last 30 days: Epstein Barr Virus (positive/negative ?)', 'timeFrame': 'Baseline'}, {'measure': 'Routine serology results dating to within the last 30 days: cytomegalovirus (positive/negative ?)', 'timeFrame': 'Baseline'}], 'primaryOutcomes': [{'measure': 'CD4+ CD25+ CD127- FoxP3+(Treg) cells: change in percentage of total lymphocytes', 'timeFrame': 'Day 8', 'description': 'Treg refers to regulatory T cells'}], 'secondaryOutcomes': [{'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 1', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 2', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 3', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 4', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 5', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 6', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 7', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 8', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 29', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 30', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 31', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 32', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 33', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 34', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 35', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 36', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 57', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 58', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 59', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 60', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 61', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 62', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 63', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of specific, pre-defined adverse events.', 'timeFrame': 'Day 64', 'description': 'The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.'}, {'measure': 'Presence/absence of abnormal vital signs', 'timeFrame': 'Day 1', 'description': '(based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)'}, {'measure': 'Presence/absence of abnormal vital signs', 'timeFrame': 'Day 8', 'description': '(based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)'}, {'measure': 'Presence/absence of abnormal vital signs', 'timeFrame': 'Day 29', 'description': '(based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)'}, {'measure': 'Presence/absence of abnormal vital signs', 'timeFrame': 'Day 57', 'description': '(based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)'}, {'measure': 'Presence/absence of abnormal vital signs', 'timeFrame': 'Day 64', 'description': '(based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)'}, {'measure': 'Presence/absence of abnormal vital signs', 'timeFrame': 'Week 13', 'description': '(based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)'}, {'measure': 'Presence/absence of abnormal vital signs', 'timeFrame': 'Week 25', 'description': '(based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)'}, {'measure': 'MedDRA classification of all adverse events throughout the study', 'timeFrame': 'Week 25', 'description': 'MedDRA refers to "Medical Dictionary for Regulatory Activities"'}, {'measure': 'Thyroid function: blood T4', 'timeFrame': 'Baseline (day 0 to day -15)'}, {'measure': 'Thyroid function: blood T4', 'timeFrame': 'Week 13'}, {'measure': 'Thyroid function: blood TSH', 'timeFrame': 'Baseline (day 0 to day -15)'}, {'measure': 'Thyroid function: blood TSH', 'timeFrame': 'Week 13'}, {'measure': 'Presence/absence of clinically significant abnormality on a lung x-ray', 'timeFrame': 'Baseline (day 0 to day -15)'}, {'measure': 'Presence/absence of clinically significant abnormality on a lung x-ray', 'timeFrame': 'Week 13'}, {'measure': 'Presence/absence of clinically significant abnormality on an electrocardiogram', 'timeFrame': 'Baseline (day 0 to day -15)'}, {'measure': 'Presence/absence of clinically significant abnormality on an electrocardiogram', 'timeFrame': 'Week 13'}, {'measure': 'Presence/absence of a clinically significant abnormality among routine laboratory tests', 'timeFrame': 'Day 1', 'description': 'The routine blood tests considered are:\n\n* haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration )\n* blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)\n* liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)\n* iron metabolism (iron, ferritin, transferrin)'}, {'measure': 'Presence/absence of a clinically significant abnormality among routine laboratory tests', 'timeFrame': 'Day 8', 'description': 'The routine blood tests considered are:\n\n* haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)\n* blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)\n* liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)\n* iron metabolism (iron, ferritin, transferrin)'}, {'measure': 'Presence/absence of a clinically significant abnormality among routine laboratory tests', 'timeFrame': 'Day 29', 'description': 'The routine blood tests considered are:\n\n* haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)\n* blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)\n* liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)\n* iron metabolism (iron, ferritin, transferrin)'}, {'measure': 'Presence/absence of a clinically significant abnormality among routine laboratory tests', 'timeFrame': 'Day 57', 'description': 'The routine blood tests considered are:\n\n* haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)\n* blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)\n* liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)\n* iron metabolism (iron, ferritin, transferrin)'}, {'measure': 'Presence/absence of a clinically significant abnormality among routine laboratory tests', 'timeFrame': 'Day 64', 'description': 'The routine blood tests considered are:\n\n* haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)\n* blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)\n* liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)\n* iron metabolism (iron, ferritin, transferrin)'}, {'measure': 'Presence/absence of a clinically significant abnormality among routine laboratory tests', 'timeFrame': 'Week 13', 'description': 'The routine blood tests considered are:\n\n* haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)\n* blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)\n* liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)\n* iron metabolism (iron, ferritin, transferrin)'}, {'measure': 'Presence/absence of a clinically significant abnormality among routine laboratory tests', 'timeFrame': 'Week 25', 'description': 'The routine blood tests considered are:\n\n* haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)\n* blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)\n* liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)\n* iron metabolism (iron, ferritin, transferrin)'}, {'measure': 'Vital capacity (% of normal)', 'timeFrame': 'Baseline (day 0 to day -15)', 'description': 'This is a measure of respiratory function.'}, {'measure': 'Vital capacity (% of normal)', 'timeFrame': 'Day 1', 'description': 'This is a measure of respiratory function.'}, {'measure': 'Vital capacity (% of normal)', 'timeFrame': 'Week 13', 'description': 'This is a measure of respiratory function.'}, {'measure': 'Vital capacity (% of normal)', 'timeFrame': 'Week 25', 'description': 'This is a measure of respiratory function.'}, {'measure': 'The ALSFRS Questionnaire', 'timeFrame': 'Day 1'}, {'measure': 'The ALSFRS Questionnaire', 'timeFrame': 'Day 29'}, {'measure': 'The ALSFRS Questionnaire', 'timeFrame': 'Day 57'}, {'measure': 'The ALSFRS Questionnaire', 'timeFrame': 'Week 13'}, {'measure': 'The ALSFRS Questionnaire', 'timeFrame': 'Week 25'}, {'measure': 'Tregs (absolute number and % CF4+ cells)', 'timeFrame': 'Day 1'}, {'measure': 'Tregs (absolute number and % CF4+ cells)', 'timeFrame': 'Day 8'}, {'measure': 'Tregs (absolute number and % CF4+ cells)', 'timeFrame': 'Day 57'}, {'measure': 'Tregs (absolute number and % CF4+ cells)', 'timeFrame': 'Day 64'}, {'measure': 'Tregs (absolute number and % CF4+ cells)', 'timeFrame': 'Week 13'}, {'measure': 'Tregs (absolute number and % CF4+ cells)', 'timeFrame': 'Week 25'}, {'measure': 'Total lymphocyte number', 'timeFrame': 'Day 1'}, {'measure': 'Total lymphocyte number', 'timeFrame': 'Day 8'}, {'measure': 'Total lymphocyte number', 'timeFrame': 'Day 57'}, {'measure': 'Total lymphocyte number', 'timeFrame': 'Day 64'}, {'measure': 'Total lymphocyte number', 'timeFrame': 'Week 13'}, {'measure': 'Total lymphocyte number', 'timeFrame': 'Week 25'}, {'measure': 'CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes', 'timeFrame': 'Day 1'}, {'measure': 'CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes', 'timeFrame': 'Day 8'}, {'measure': 'CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes', 'timeFrame': 'Day 57'}, {'measure': 'CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes', 'timeFrame': 'Day 64'}, {'measure': 'CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes', 'timeFrame': 'Week 13'}, {'measure': 'CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes', 'timeFrame': 'week 25'}, {'measure': 'effector T cells: number and % of CD4 cells', 'timeFrame': 'Day 1', 'description': 'This is measured as CD4+ lymphocytes minus regulatory T cells'}, {'measure': 'effector T cells: number and % of CD4 cells', 'timeFrame': 'Day 8', 'description': 'This is measured as CD4+ lymphocytes minus regulatory T cells'}, {'measure': 'effector T cells: number and % of CD4 cells', 'timeFrame': 'Day 57', 'description': 'This is measured as CD4+ lymphocytes minus regulatory T cells'}, {'measure': 'effector T cells: number and % of CD4 cells', 'timeFrame': 'Day 64', 'description': 'This is measured as CD4+ lymphocytes minus regulatory T cells'}, {'measure': 'effector T cells: number and % of CD4 cells', 'timeFrame': 'Week 13', 'description': 'This is measured as CD4+ lymphocytes minus regulatory T cells'}, {'measure': 'effector T cells: number and % of CD4 cells', 'timeFrame': 'Week 25', 'description': 'This is measured as CD4+ lymphocytes minus regulatory T cells'}, {'measure': 'Phosphorylated neurofilament heavy protein (pNfH) levels in serum', 'timeFrame': 'day 1'}, {'measure': 'Light chain neurofilament levels in serum', 'timeFrame': 'Day 1'}, {'measure': 'Light chain neurofilament levels in serum', 'timeFrame': 'Week 13'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['low-dose interleukin 2'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'referencesModule': {'references': [{'pmid': '32651161', 'type': 'RESULT', 'citation': 'Camu W, Mickunas M, Veyrune JL, Payan C, Garlanda C, Locati M, Juntas-Morales R, Pageot N, Malaspina A, Andreasson U, Kirby J, Suehs C, Saker S, Masseguin C, De Vos J, Zetterberg H, Shaw PJ, Al-Chalabi A, Leigh PN, Tree T, Bensimon G. Repeated 5-day cycles of low dose aldesleukin in amyotrophic lateral sclerosis (IMODALS): A phase 2a randomised, double-blind, placebo-controlled trial. EBioMedicine. 2020 Sep;59:102844. doi: 10.1016/j.ebiom.2020.102844. Epub 2020 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate in ALS patients the regulatory T cell early response to two low-doses of IL-2 at 1 and 2 MIU per day after one course of 5 consecutive days comparatively to placebo.', 'detailedDescription': 'This is a phase II study on ld-IL-2 as a therapeutic agent for ALS which aims at defining the activity and safety of a range a doses for subsequent use of the best dose in a phase II/III trial. For ethical reasons, ld-IL-2 must be tested as an add-on therapy to riluzole hence all patients will need to be treated with riluzole for at least three months prior to entry. A randomized (1:1:1), placebo-controlled, double-blind, parallel group trial will be carried out to assess ld-IL-2 activity on regulatory T cells and immuno-inflammatory markers in ALS patients treated for 3 months (5 days every four weeks repeated three times).\n\nThe secondary objectives of this study are:\n\nA. To evaluate maintenance of Tcell response after three repeated 5-day courses at one course every four weeks for 12 weeks.\n\nB. To evaluate the safety of ld-IL-2 therapy in an ALS population, with an overall follow-up of 6 months (up to 15 weeks after last administration); C. To evaluate functional changes throughout the study; D. To evaluate changes in other pre-defined blood cytology parameters, and a blood biomarker for axonal damage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient has been correctly informed\n* The patient must have given his/her informed and signed consent.\n* The patient must be insured or beneficiary of a health insurance plan.\n* The patient is at least 18 years old and less than 75 years old\n* Probable, or laboratory-supported probable or definite ALS as defined by El Escorial Revised ALS diagnostic criteria (according to Airlie House Conference 1988)\n* Stable on riluzole treatment for more than 3 months with liver function test results \\< 2ULN\n* Disease duration ≤ 5 years\n* Vital capacity ≥ 70% of normal\n* Ability to swallow without the requirement for nasogastric or PEG feeding\n* Agreement for patient to use an adequate method of contraception throughout the study and for 2 weeks after post study visit\n* The patient is available and willing to participate in seven study visits occurring at the CHU within the next six months\n\nExclusion Criteria:\n\n* The patient is participating in another interventional study\n* Within the past three months, the patient has participated in another interventional\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection\n* The patient is an adult under guardianship\n* The patient refuses to sign the consent\n* It is impossible to correctly inform the patient\n* Other life threatening disease\n* Presence of contra-indicated concomitant treatments or with potential neuroprotective benefit (see section 11.2 of the protocol)\n* Presence of tracheostomy or non-invasive ventilation\n* Use of Percutaneous endoscopic gastrostomy (PEG) or nasogastric tube\n* Presence of clinical infection (treated or untreated)\n* Positive serology for CMV, EBV (confirmed by viral load), or HIV\n* Vaccination within 8 weeks prior to first experimental dosing\n* Other disease precluding functional assessments\n* Cancer within the past 5 years (except stable non-metastatic basal cell skin carcinoma or in situ carcinoma of the cervix)\n* Severe cardiac or pulmonary disease\n* Documented auto-immune disorders except asymptomatic Hashimoto thyroiditis\n* Women of child bearing age without contraception or pregnant or breast feeding\n* Any clinically significant laboratory abnormality (excepting cholesterol, triglyceride and glucose)'}, 'identificationModule': {'nctId': 'NCT02059759', 'acronym': 'IMODALS', 'briefTitle': 'Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2', 'orgStudyIdInfo': {'id': 'LOCAL/2014/WC-01'}, 'secondaryIdInfos': [{'id': '2014-001327-71', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients in this arm will receive sub-cutaneous injections of placebo (same vehicle as for experimental arms, and same volume) for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).\n\nIntervention: Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '1.0 IL-2', 'description': 'Patients in this arm will receive sub-cutaneous injections corresponding to 1.0 MIU of IL-2 per injection for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).\n\nIntervention: 1.0 MIU IL-2 per day', 'interventionNames': ['Drug: 1.0 MIU IL-2 per day']}, {'type': 'EXPERIMENTAL', 'label': '2.0 IL-2', 'description': 'Patients in this arm will receive sub-cutaneous injections corresponding to 2.0 MIU of IL-2 per injection for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).\n\nIntervention: 2.0 MIU IL-2 per day', 'interventionNames': ['Drug: 2.0 MIU IL-2 per day']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients in this arm will receive sub-cutaneous injections of placebo (same vehicle as for experimental arms, and same volume) for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).', 'armGroupLabels': ['Placebo']}, {'name': '1.0 MIU IL-2 per day', 'type': 'DRUG', 'otherNames': ['Aldesleukine', 'Proleukin'], 'description': 'Patients in this arm will receive sub-cutaneous injections corresponding to 1.0 MIU of IL-2 per injection for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).', 'armGroupLabels': ['1.0 IL-2']}, {'name': '2.0 MIU IL-2 per day', 'type': 'DRUG', 'otherNames': ['Aldesleukine', 'Proleukin'], 'description': 'Patients in this arm will receive sub-cutaneous injections corresponding to 2.0 MIU of IL-2 per injection for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).', 'armGroupLabels': ['2.0 IL-2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHRU de Montpellier - Hôpital Gui de Chauliac', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Raul Juntas-Morales, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHRU de Montpellier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}