Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2

NCT02059759 | Completed Phase 2 DMC

• 2 other identifiers: LOCAL/2014/WC-012014-001327-71
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

low-dose interleukin 2

Outcome Measures

Primary Outcomes (1)

• CD4+ CD25+ CD127- FoxP3+(Treg) cells: change in percentage of total lymphocytes

  Treg refers to regulatory T cells

  Day 8

Secondary Outcomes (83)

• Presence/absence of specific, pre-defined adverse events.

  Day 1

• Presence/absence of specific, pre-defined adverse events.

  Day 2

• Presence/absence of specific, pre-defined adverse events.

  Day 3

• Presence/absence of specific, pre-defined adverse events.

  Day 4

• Presence/absence of specific, pre-defined adverse events.

  Day 5

Other Outcomes (10)

• Age (years)

  Baseline

• Sex (male/female)

  Baseline

• Body mass index (kg/m^2)

  Baseline

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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). Intervention: Placebo

Drug: Placebo

1.0 IL-2

EXPERIMENTAL

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). Intervention: 1.0 MIU IL-2 per day

Drug: 1.0 MIU IL-2 per day

2.0 IL-2

EXPERIMENTAL

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). Intervention: 2.0 MIU IL-2 per day

Drug: 2.0 MIU IL-2 per day

Interventions

Placebo DRUG

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).

Placebo

1.0 MIU IL-2 per day DRUG

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).

Also known as: Aldesleukine, Proleukin

1.0 IL-2

2.0 MIU IL-2 per day DRUG

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).

Also known as: Aldesleukine, Proleukin

2.0 IL-2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another interventional study
• Within the past three months, the patient has participated in another interventional
• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHRU de Montpellier - Hôpital Gui de Chauliac

Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 32651161 RESULT

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Raul Juntas-Morales, MD

  CHRU de Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 11, 2014
• Study Start: September 1, 2015
• Primary Completion: May 25, 2016
• Study Completion: May 25, 2016
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

FR (1)