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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes
• Treatments: Aldesleukin; Interleukin-2

Criteria

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)