Relapsing Remitting Multiple Sclerosis Clinical Trial
— MS-IL2Official title:
Biological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple Sclerosis. Multicentric Randomized Study
Verified date | November 2020 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Interleukin-2 (IL-2) was initially discovered and used as a stimulator of effector T lymphocytes (Teffs), but is now viewed as a very promising immunoregulatory drug having the capacity to stimulate regulatory T cells (Tregs). At low dose, Il-2 tips the Treg/Teff balance towards Tregs. Recently, it has been shown that Tregs of MS patients have reduced proliferative potential. MS-IL2 will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a Relapsing-Remitting Multiple Sclerosis (RRMS), with the aim to stimulate Treg and define potential clinical benefits
Status | Completed |
Enrollment | 30 |
Est. completion date | June 15, 2020 |
Est. primary completion date | October 11, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age 18-65 years old ; - Male and Female; - Presenting relapsing remitting multiple sclerosis as determined by revised McDonald criteria (2010) ; - On MRI : 1) Presenting 1-2 lesions enhanced by gadolinium (Gd+) (T1) without clinical expression of the disease clinique upon inclusion or 6 months prior to inclusion or 2) presenting one new lesion T2 - Expanded Disability Status Scale (EDSS) score comprised between 0 and 6; - No flare (with or without any corticosteroid therapy) for the past 2 months - Under ß-Interferon treatment for = 6 months ; or any other first-line treatment of the Relapsing-Remitting Multiple Sclerosis (RRMS): Dimethyl fumarate or teriflunomide treatment for = 6 months or glatiramer acetate for = 9 months - For women of childbearing age, contraception for more than 2 weeks upon confirmation of inclusion criteria and negative Beta HCG on inclusion visit (D-30 to D-7); - Patient informed consent should be signed by the patient and investigator before performing any clinical examination required for the study. - Affiliation to the French Social Security Regimen Exclusion Criteria: - Number of lesions enhanced by gadolinium (Gd+) on MRI in T1 > 2 upon inclusion; - Known intolerance to IL2 (see SPC): - Hypersensibility to active substance or one of the excipients ; - Signs of evolving infection requiring treatment - Other clinically significant chronic disorders (beside RR-MS) - History of organ allograft - Administration of a non-authorized treatment; bolus of corticosteroids in the last 2 months, or treatment with cyclophosphamide, mitoxantrone, or rituximab in the last 6 months; - Heart failure (= grade III NYHA), renal insufficiency, or hepatic insufficiency (transaminase>5N), or lung failure - White blood cell count <3000 /mm3, lymphocytes< 1000 /mm3, platelets <150 000 /mm3 - Poor venous access not allowing repeated blood tests - Vaccination with live attenuated virus in the months preceding the inclusion or planned during the study - Surgery with general anaesthesia during the last 2 months or surgery planned during the study - Participation in other biomedical research in the last one month or planned during the study - Concomitant psychiatric disease or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give informed consent - Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or basocellular carcinoma) - Pregnant or lactating women; - Men and women of childbearing potential without effective contraception for the duration of treatment - Patients under a measure of legal protection |
Country | Name | City | State |
---|---|---|---|
France | Centre d'investigation Clinique - Pitié salpêtrière | Paris | |
France | Centre d'investigation clinique Biothérapie Immunologie (CIC-BTi) - Groupe Hospitalier Pitié-Salpêtrière - AP-HP | Paris | |
France | Département des maladies du système nerveux et Centre d'investigation clinique - Groupe Hospitalier Pitié-Salpêtrière - AP-HP | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Fondation ARSEP/AFM |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treg response to low dose IL2 induction course period, expressed as % of total CD4 cells | at day5 | ||
Secondary | Change in Treg percentage on D15 after induction (D1-D5) compared to baseline | at day15 | ||
Secondary | Change in Treg percentage from D15 to M6 compared to baseline | Day 15 to Day 169 | ||
Secondary | The cumulative number of new lesions enhanced by Gd+ (Sum of Gd + lesions on T1 MRI on M2, M4 and M6) | Day 57, Day 113 and Day 169 | ||
Secondary | Frequency of patients free of Gd+ lesions at M6 | Day 169 | ||
Secondary | The cumulative number of new T2 lesions | Day 169 | ||
Secondary | Annual relapse rate (number of relapses observed over a 6 month period) | Day 169 | ||
Secondary | % of patients with flare | Day 169 | ||
Secondary | % of disease free patient i.e % of patient with no clinical symptoms and no activity on MRI | Day 169 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01945359 -
Pilot Study to Assess Disease Stability in a Natalizumab to Dimethyl Fumarate Crossover Design
|
N/A | |
Completed |
NCT01456416 -
Glatiramer Acetate for Multiple Sclerosis With Autoimmune Comorbidities
|
Phase 4 | |
Completed |
NCT01450124 -
Safety, Tolerability And Mechanism Of Action Of Boswellic Acids (BA) In Multiple Sclerosis (SABA)
|
Phase 2 | |
Recruiting |
NCT05277740 -
Implementation of a Novel Functional Eye-Tracking Biomarker for Multiple Sclerosis
|
||
Completed |
NCT03718247 -
Utilization of the Ketogenic Diet in Patient With Relapsing Remitting MS
|
||
Active, not recruiting |
NCT03471338 -
Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme
|
N/A | |
Recruiting |
NCT03004079 -
Clinical Importance of Glucose Regulation in Relapsing MS
|
||
Terminated |
NCT02266121 -
Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis
|
N/A | |
Completed |
NCT01963611 -
Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)
|
Phase 2 | |
Active, not recruiting |
NCT01464905 -
Phase 3 Study to Evaluate Efficacy and Safety of NU100 in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
|
Phase 3 | |
Completed |
NCT01225289 -
Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients
|
Phase 4 | |
Recruiting |
NCT00242268 -
A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis
|
Phase 3 | |
Completed |
NCT00203086 -
A Study to Evaluate the Long Term Safety and Effectiveness of Novantrone Therapy Followed by Copaxone Treatment for Multiple Sclerosis
|
Phase 4 | |
Completed |
NCT00616187 -
Atorvastatin in Relapsing-Remitting Multiple Sclerosis
|
Phase 2 | |
Recruiting |
NCT06083753 -
Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis
|
Phase 2 | |
Active, not recruiting |
NCT04602390 -
Assessment of ANK-700 in Patients With Relapsing Remitting Multiple Sclerosis
|
Phase 1 | |
Recruiting |
NCT06159712 -
Comparative Study of High-Efficacy Disease Modifying Treatment of Relapsing Multiple Sclerosis
|
N/A | |
Recruiting |
NCT04604041 -
Investigation of Subclinical Markers of Multiple Sclerosis
|
||
Terminated |
NCT03536559 -
Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT02490982 -
Teriflunomide Observational Effectiveness Study
|