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Rheumatoid ArthritisPhase 2TRANSREGNCT01988506

Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases

A Phase 2 study testing Interleukin 2 in people with Rheumatoid Arthritis and Ankylosing Spondylitis, run by Assistance Publique - Hôpitaux de Paris at 11 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

TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a set of 14 autoimmune and auto-inflammatory diseases, with the aim to select diseases in which further therapeutic development will be performed. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Interleukin 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
11 sitesFrance
Study dates
6 Jan 2014to 1 Apr 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age > 18 year
  • male or female
  • documented diagnosis of one AIID among the 14 diseases selected (following consensual specific criteria)
  • stable or moderately active disease (except Lupus) under standard treatment (≥ 2 months) at the time of inclusion (except Sclerosing Cholangitis, Gougerot-sjögren, Takayasu's Disease and Systemic Sclerosis)
  • normal thyroid function (with or without treatment)
  • effective contraception for more than two weeks at inclusion and negative beta HCG test for women of childbearing potential,
  • affiliated to the social security system
  • written informed consent form.

Who cannot join

  • known intolerance for IL2 (see SPC),
  • administration of a non-authorized treatment and/or IV bolus of corticosteroids in the last 2 months,
  • vaccination with live attenuated virus in the months preceding the inclusion or planned during the study
  • other severe or progressive autoimmune/inflammatory pathology,
  • low white blood cell count<2000/mm3, lymphocytes <600/mm3, platelets <80 000/mm3,
  • heart failure (≥ grade III NYHA), renal insufficiency (Cockcroft< 60ml/mn except patients with lupus or Wegener's granulomatosis) or hepatic insufficiency (transaminases> 5N except for patients with autoimmune hepatitis), or lung failure,
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  • significant abnormality in chest X-ray other than these linked to the diseases under investigation
  • cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or basocellular carcinoma)
  • poor venous access not allowing repeated blood tests,
  • restrictive diet or parenteral nutrition,
  • surgery during the last 2 months or surgery planned during the study,
  • participation in other biomedical research in the last 3 months or planned during the study.
  • pregnant or lactating women,
  • 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,
  • positive HIV serology, active hepatitis B or EBV infection,
  • patients under a measure of legal protection

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

France11 sites

  • Henri Mondor - Médecine Interne

    Créteil, 94010

  • Médecine interne - Hôpital Saint-Antoine

    Paris, 75012

  • Service de médecine vasculaire - HEGP

    Paris, 75015

  • Service d' Hépato Gastro Entérologie - Hôpital SAINT-ANTOINE

    Paris, Île-de-France Region, 75012

  • Service de Gastro Entérologie - Hôpital SAINT-ANTOINE

    Paris, Île-de-France Region, 75012

  • Service de Rhumatologie - Hôpital SAINT-ANTOINE

    Paris, Île-de-France Region, 75012

  • CIC - Hôpital PITIE SALPETRIERE

    Paris, Île-de-France Region, 75013

  • Service de Médecine Interne - Hôpital PITIE SALPETRIERE

    Paris, Île-de-France Region, 75013

  • Service de Rhumatologie - Hôpital PITIE SALPETRIERE

    Paris, Île-de-France Region, 75013

  • Service de Dermatologie - Hôpital COCHIN

    Paris, Île-de-France Region, 75014

  • Centre Hépato-Biliaire - Hôpital Paul Brousse

    Villejuif, Île-de-France Region, 94800

Other trials in France

About this study

Official title: Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach

TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a set of 14 autoimmune and auto-inflammatory diseases, with the aim to select diseases in which further therapeutic development will be performed. Extensive biological- and immune-monitoring pre- and post-IL2 will contribute (i) to define the common or distinct processes responsible for the breakdown of immunological tolerance in these pathologies and (ii) to discover potential biomarkers of the IL2 response.

Read the detailed description

Protocol: TRANSREG is a multicentric, uncontrolled, open-label study, comparing biological and clinical responses to the administration of low doses IL2 across 14 selected pathologies: rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, psoriasis, Behcet's disease, Wegener's granulomatosis, Takayasu's disease, Crohn's disease, ulcerative colitis, autoimmune hepatitis, sclerosing cholangitis, Gougerot-sjögren, Systemic Sclerosis and Idiopathic Thrombocytopenic Purpura. Methods: Each patient will receive 1MUI /day of IL2 from Day-1 to Day-5 (the induction period), and then every 2 weeks (except systemic lupus erythematosus's patients will received every week) from Day-15 to Day-180 (the maintenance period). Patients will thereafter be followed up for 12 months (Day-181-Day-540). For each pathology, 6 patients will be included at Pitié-Salpêtrière, Cochin, Saint Antoine, Paul Brousse and Henri Mondor hospitals in Paris and Créteil, France. An interim analysis will be performed in each pathology group when the first six patients have received at least 3 months of treatment. In those pathology groups in which a Treg response will be documented, six additional patients will be included. In total, a minimum of 84 patients and up to 132 patients will be enrolled in this study. Primary efficacy endpoint is the Treg response at Day-8 compared to baseline. Secondary efficacy endpoints are:- evolution of the Treg response during the maintenance period,- the changes in markers of inflammation - the clinical response, evaluated by means of global generic scales [Clinical Global Impression severity scale (CGI-sev) and Clinical Global Impression efficacy index (CGI-eff)] as well as specific clinical and biological evaluations for each disease, - the frequency of relapses, - the assessment of quality of life (scale EuroQL-5). Expected Results: TRANSREG will define which patients respond to IL2, whether per pathology or according to pre-treatment phenomics, allowing to guide further clinical development of low dose IL2 in autoimmune and auto-inflammatory diseases.

Being tested
Interleukin 2
Keywords
IL2,, Interleukin 2,, ILT101, Proleukin®, RhIL-2, Auto-immune disease, Inflammatory disease, Inflammation, Regulatory T cells,, Treg, Immunoregulation, Immune tolerance
Medical subject headings
Arthritis, Rheumatoid, Spondylitis, Ankylosing, Lupus Erythematosus, Systemic, Psoriasis, Behcet Syndrome, Granulomatosis with Polyangiitis, Aortic Arch Syndromes, Crohn Disease

What participants receive

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

  • Interleukin 2Drug

    Induction period: repeated administration of low-dose IL-2 (1MUI/day, sc) during 5 consecutive days.Maintenance period: treatment with IL-2, 1MUI once every 15 days (except systemic lupus erythematosus's patients every 7 days) for 6 months

Study groups in NCT01988506
Study groupRoleWhat they receive
Interleukin 2ExperimentalInterleukin 2, 1MUI.= Proleukin®, RhIL-2
Receives: Drug: Interleukin 2

What is being measured

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

  1. Percentages of Tregs

    Change in Treg percentage (percentages of Tregs within the CD4+ lymphocytes) at Day-8 after administration of low-dose of IL2 compared to baseline (Day0)

    Measured: Day8

Secondary outcomes (8)

  1. Percentages of Tregs

    Changes in Treg percentage at Day 15, 29, 85, 183, 240, 360 and 540 compared to baseline (Day0)

    Measured: Day 15, 29, 85, 183, 240, 360 and 540

  2. inflammation markers (CRP and CRP ultra sensible)

    Changes in levels of inflammation markers

    Measured: Day 0, 1, 8, 15, 29, 85, 183, 240, 360 and 540

  3. markers of inflammatory anemia (Hemoglobin, serum iron level, transferrin) ferritin

    Changes in levels of inflammation markers

    Measured: Day 0, 1, 8, 15, 29, 85, 183, 240, 360 and 540

  4. Number of relapses

    Measured: up to Day540

  5. CGI-sev, CGI-activity and CGI-eff scales

    Change in the clinical global impression severity and efficacy scale (CGI-sev, CGI-act and CGI-eff scales) at Day 85, 183, 240, 360 and 540 compared to baseline (Day1)

    Measured: Day 85, 183, 240, 360 and 540

  6. EuroQL-5 scale

    Change in the quality of life (EuroQL-5 scale)

    Measured: Day 183

  7. Evolution of clinical, biological or radiological criteria specific to each disease

    Changes in disease-specific score and/or evolution of clinical, biological or radiological criteria specific to each disease

    Measured: up to Day 540

  8. Safety Assessment

    Safety Assessment all along the observation period (Day-1 to Day-240): Safety assessment will include vital signs, adverse events and concomitant medications collection as well as biology during the 6 months of the treatment period; .In addition, the evolution of the disease will be followed up to 1 year after IL2- treatment stop.

    Measured: up to Day 540

Timeline

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

  1. First posted20 Nov 2013 (estimated)
  2. Study start6 Jan 2014
  3. Primary completion16 Oct 2019
  4. Study completion1 Apr 2021

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01988506
Sponsor's protocol ID
P130101
Other IDs
2013-001232-22
Acronym
TRANSREG
Status last verified
Jul 2021
First submitted
7 Nov 2013
Last updated
20 Jul 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Rosenzwajg M, Lorenzon R, Cacoub P, Pham HP, Pitoiset F, El Soufi K, RIbet C, Bernard C, Aractingi S, Banneville B, Beaugerie L, Berenbaum F, Champey J, Chazouilleres O, Corpechot C, Fautrel B, Mekinian A, Regnier E, Saadoun D, Salem JE, Sellam J, Seksik P, Daguenel-Nguyen A, Doppler V, Mariau J, Vicaut E, Klatzmann D. Immunological and clinical effects of low-dose interleukin-2 across 11 autoimmune diseases in a single, open clinical trial. Ann Rheum Dis. 2019 Feb;78(2):209-217. doi: 10.1136/annrheumdis-2018-214229. Epub 2018 Nov 24.

    PubMed 30472651

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Interleukin 2 in people with Rheumatoid Arthritis and Ankylosing Spondylitis, run by Assistance Publique - Hôpitaux de Paris at 11 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 8 inclusion and 16 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 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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. 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?

Percentages of Tregs (time frame: Day8). 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 NCT01988506, 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 20 Jul 2021.

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