Biological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02424396
• Date of registration: 20/04/2015
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Biological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple Sclerosis MS-IL2
• Scientific title: Biological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple Sclerosis. Multicentric Randomized Study
• Date of first enrolment: June 13, 2016
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02424396
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: David Klatzmann
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis

Intervention(s)

Drug: IL2

Drug: Placebo

Primary Outcome(s)

Treg response to low dose IL2 induction course period, expressed as % of total CD4 cells [Time Frame: at day5]

Secondary Outcome(s)

Frequency of patients free of Gd+ lesions at M6 [Time Frame: Day 169]

% of patients with flare [Time Frame: Day 169]

Annual relapse rate (number of relapses observed over a 6 month period) [Time Frame: Day 169]

% of disease free patient i.e % of patient with no clinical symptoms and no activity on MRI [Time Frame: Day 169]

Change in Treg percentage from D15 to M6 compared to baseline [Time Frame: Day 15 to Day 169]

The cumulative number of new lesions enhanced by Gd+ (Sum of Gd + lesions on T1 MRI on M2, M4 and M6) [Time Frame: Day 57, Day 113 and Day 169]

Change in Treg percentage on D15 after induction (D1-D5) compared to baseline [Time Frame: at day15]

The cumulative number of new T2 lesions [Time Frame: Day 169]

Secondary ID(s)

2014-000088-82

P130102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fondation ARSEP/AFM