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Relapsing Remitting Multiple SclerosisPhase 2MS-IL2NCT02424396

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

A Phase 2 study testing IL2 in people with Relapsing Remitting Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Relapsing Remitting Multiple Sclerosis
What is being tested?
IL2
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
3 sitesFrance
Study dates
13 Jun 2016to 15 Jun 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Centre d'investigation Clinique - Pitié salpêtrière

    Paris, 75013

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

    Paris, 75013

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

    Paris, 75013

Other trials in France

About this study

Official title: Biological Activity and Safety of Low Dose IL2 in Relapsing Remitting Multiple Sclerosis. Multicentric Randomized Study

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

Read the detailed description

In MS-IL2, 30 RRMS patients will be treated in a randomized, double-blind, placebo controlled clinical trial. IL-2 will be administered first as an induction course of IL-2 or placebo each day for 5 days, followed by a maintenance course at the same dose or placebo every two weeks over 6 months.

The primary efficacy criteria will be the % change from baseline in Treg at day-5, which is indicative of the biological response to IL-2.

The secondary efficacy criteria will be (i) the maintenance of regulatory T cells during the 6 months of treatment with IL-2 vs. placebo and (ii) the stabilization or regression of the disease as determined by disease activity parameters assessed by MRI (cumulative number of new lesions in T1 enhanced by gadolinium after 6 months) in the groups treated with IL-2 compared to placebo.

Expected impact: MS-IL2 will define which patient respond to IL2 and which doses prevent relapses in RRMS. In addition, the deep phenomics studies will further provide the foundation for a clinical phase II to define clinical efficacy.

Being tested
IL2, Placebo
Keywords
Interleukin 2, IL2, Relapsing Remitting Multiple Sclerosis, Autoimmune diseases, Regulatory T cells, Tregs
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IL2Drug

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

  • PlaceboDrug

Study groups in NCT02424396
Study groupRoleWhat they receive
1 : IL2ExperimentalInterleukin-2 (ILT-101)
Receives: Drug: IL2
2 : PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: at day5

Secondary outcomes (8)

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

    Measured: at day15

  2. Change in Treg percentage from D15 to M6 compared to baseline

    Measured: Day 15 to Day 169

  3. The cumulative number of new lesions enhanced by Gd+ (Sum of Gd + lesions on T1 MRI on M2, M4 and M6)

    Measured: Day 57, Day 113 and Day 169

  4. Frequency of patients free of Gd+ lesions at M6

    Measured: Day 169

  5. The cumulative number of new T2 lesions

    Measured: Day 169

  6. Annual relapse rate (number of relapses observed over a 6 month period)

    Measured: Day 169

  7. % of patients with flare

    Measured: Day 169

  8. % of disease free patient i.e % of patient with no clinical symptoms and no activity on MRI

    Measured: Day 169

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2015 (estimated)
  2. Study start13 Jun 2016
  3. Primary completion11 Oct 2019
  4. Study completion15 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02424396
Sponsor's protocol ID
P130102
Other IDs
2014-000088-82, 2014
Acronym
MS-IL2
Status last verified
Nov 2020
First submitted
20 Apr 2015
Last updated
9 Nov 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37245191

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IL2 in people with Relapsing Remitting Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treg response to low dose IL2 induction course period, expressed as % of total CD4 cells (time frame: at day5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02424396, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.

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