NCT02424396

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2016

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 13, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

3.3 years

First QC Date

April 20, 2015

Last Update Submit

November 6, 2020

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Interleukin 2, IL2Relapsing Remitting Multiple SclerosisAutoimmune diseasesRegulatory T cells, Tregs

Outcome Measures

Primary Outcomes (1)

  • Treg response to low dose IL2 induction course period, expressed as % of total CD4 cells

    at day5

Secondary Outcomes (8)

  • Change in Treg percentage on D15 after induction (D1-D5) compared to baseline

    at day15

  • Change in Treg percentage from D15 to M6 compared to baseline

    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)

    Day 57, Day 113 and Day 169

  • Frequency of patients free of Gd+ lesions at M6

    Day 169

  • The cumulative number of new T2 lesions

    Day 169

  • +3 more secondary outcomes

Study Arms (2)

1 : IL2

EXPERIMENTAL

Interleukin-2 (ILT-101)

Drug: IL2

2 : Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

IL2DRUG

Induction period: repeated administration of low-dose IL-2 Maintenance period: treatment with IL-2

1 : IL2
PlaceboDRUG
2 : Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years old ;
  • Male and Female;
  • Presenting relapsing remitting multiple sclerosis as determined by revised McDonald criteria (2010) ;
  • 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 β-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
  • 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

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre d'investigation Clinique - Pitié salpêtrière

Paris, 75013, France

Location

Centre d'investigation clinique Biothérapie Immunologie (CIC-BTi) - Groupe Hospitalier Pitié-Salpêtrière - AP-HP

Paris, 75013, France

Location

Département des maladies du système nerveux et Centre d'investigation clinique - Groupe Hospitalier Pitié-Salpêtrière - AP-HP

Paris, 75013, France

Location

Related Publications (1)

  • Louapre C, Rosenzwajg M, Golse M, Roux A, Pitoiset F, Adda L, Tchitchek N, Papeix C, Maillart E, Ungureanu A, Charbonnier-Beaupel F, Galanaud D, Corvol JC, Vicaut E, Lubetzki C, Klatzmann D. A randomized double-blind placebo-controlled trial of low-dose interleukin-2 in relapsing-remitting multiple sclerosis. J Neurol. 2023 Sep;270(9):4403-4414. doi: 10.1007/s00415-023-11690-6. Epub 2023 May 28.

    PMID: 37245191DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingAutoimmune Diseases

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Officials

  • David Klatzmann

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 23, 2015

Study Start

June 13, 2016

Primary Completion

October 11, 2019

Study Completion

June 15, 2020

Last Updated

November 9, 2020

Record last verified: 2020-11

Locations

FR(3)