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NCT05544448Completed

In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases

Source: ClinicalTrials.gov · Last updated 11 Feb 2026

Brief summary (registry, in English)

Interleukin 2 (IL-2) is a critical cytokine for the survival and function of regulatory T cells (LTreg). This cytokine has a dual role in the immune system. IL-2 stimulates immune responses by acting on the intermediate affinity IL-2R receptor, IL-2Rβγ, expressed by conventional T cells (LTconv) during activation, but also contributes to the inhibition of immune responses via LTreg that express the high affinity receptor IL-2Rαβγ. This difference in IL-2 receptor affinity for IL-2 has led to the development of low-dose IL-2 therapy to stimulate LTreg and improve control of excessive inflammation in autoimmune (AID), inflammatory or alloimmune diseases Low-dose IL-2 therapy is being studied in several of these diseases such as systemic lupus erythematosus, type 1 diabetes, alopecia, HCV (hepatitis C virus)-induced vasculitis, atopic dermatitis and chronic allo-transplantation-related graft-versus-host disease (GVHD). Some of these studies have shown an increase in LTreg numbers and an improvement in certain clinical signs. To improve LTreg targeting in autoimmune diseases, inflammatory diseases or GVHD, mutated IL-2s (muteins) have been developed with selective LTreg agonist properties. These IL-2 muteins are linked to an Fc fragment to increase their half-life. Two IL-2 variants (IL-2Vs)-Fc preferentially stimulate STAT5 phosphorylation in LTregs compared to conventional FoxP3- (LTconv) CD4+ or CD8+ T cells

Status (registry)
Completed
Study type
Interventional
Enrollment
67 (actual)
First submitted
14 Sept 2022
Start date
2 Oct 2023
Primary completion date
6 Jun 2024
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT05544448

What you commit to

  • Study type: Interventional
  • Participants enrolled: 67
  • From 2 Oct 2023 to the primary completion date, 6 Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Ongoing treatment with high doses (\>1 mg/kg/d) of systemic corticosteroid therapy
  • Ongoing treatment with JAK inhibitors
    • Non-inclusion criteria for Nephrology and Transplantation Department:
  • Ongoing treatment with doses \>10 mg/d Prednisone
  • Ongoing treatment with Cellcept, Endoxan, Imurel, Belimumab, Anti-CD20, Methotrexate
  • Ongoing treatment with JAK inhibitors
    • Non-inclusion criteria for Neurology Department:
  • Treatment with systemic corticosteroid therapy, Fingolimod or Teriflunomide
  • Ongoing treatment with JAK inhibitors
  • Ongoing treatment with doses \>15 mg/d Prednisone
  • Treatment with Rituximab or Tocilizumab
  • Ongoing treatment with JAK inhibitors
  • Ongoing immunosuppressive therapy
  • Ongoing treatment with JAK inhibitors
    • Non-inclusion criteria for Dermatology Department:
  • Ongoing treatment with Methotrexate
  • Ongoing treatment with JAK inhibitors
  • Ongoing treatment with doses \>10 mg/d prednisone

Lab values

  • Lymphocytosis \< 0.5 G/L
    • Non-inclusion criteria for Rheumatology Department:
  • Lymphocytosis \< 0.5 G/L
    • Non-inclusion criteria for Internal Medicine - Endocrinology Department:

Other

  • Non-inclusion criteria common to all patients:
  • Patient under guardianship, curatorship or judicial protection
  • Pregnant, parturient or breastfeeding woman
  • Patient deprived of liberty
  • Patient hospitalized without consent
  • Patient admitted to a health or social institution for purposes other than research
  • Minor patient
  • Adult patient unable to express consent
  • Refusal to participate
  • Patient on AME
    • Non-inclusion criteria specific by department:
    • Non-inclusion criteria for Clinical Hematology Department:

Who the study is looking for

  • Inclusion criteria common to all patients in different departments:
  • Age18 years
  • Affiliated to social security or entitled to
  • Patient who has been informed of the study and has signed a free and informed consent
  • Patient with GVHD following allogeneic hematopoietic stem cell transplantation (HSC)
  • Or with acquired bone marrow suppression
  • Lymphocytosis \> 0.5 G/L
  • \- Patient with systemic lupus erythematosus (ACR classification criteria)
  • \- Patient with multiple sclerosis (criteria of Mc Donald 2017)
  • \- Patient with rheumatoid arthritis (ACR classification criteria)
  • \- Patient with Basedow disease, Hashimoto's thyroiditis
  • \- Patient with vitiligo or alopecia areata or atopic dermatitis

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hôpital Henri Mondor, 1 rue Gustave Eiffel,
Coordinator of this site? Confirm its status		CréteilFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.