Study Purpose:
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.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
Placebo, 1.0 MIU IL-2 per day, 2.0 MIU IL-2 per day
Placebo:
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
Raul Juntas-Morales, MD, CHRU de Montpellier
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
CHRU de Montpellier - Hôpital Gui de Chauliac
Montpellier, United States
Full Study Summary:
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).
The secondary objectives of this study are:
A. To evaluate maintenance of Tcell response after three repeated 5-day courses at one course every four weeks for 12 weeks.
B. 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.
The secondary objectives of this study are:
A. To evaluate maintenance of Tcell response after three repeated 5-day courses at one course every four weeks for 12 weeks.
B. 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.
Study Sponsor:
Centre Hospitalier Universitaire de Nīmes
Estimated Enrollment:
36
Estimated Study Start Date:
08 / 31 / 2015
Estimated Study Completion Date:
05 / 01 / 2016
Posting Last Modified Date:
06 / 01 / 2016
Date Study Added to neals.org:
02 / 11 / 2014
For additional information, please visit clinicaltrials.gov: https://clinicalt...+Sclerosis&rank=1
Minimum Age:
18 Years
Maximum Age:
75 Years
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)
CHRU de Montpellier - Hôpital Gui de Chauliac
Montpellier 34295
France