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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.
Inclusion criteria specific by department: Inclusion criteria for Clinical Hematology Department:
  • - Patient with GVHD following allogeneic hematopoietic stem cell transplantation (HSC) - Or with acquired bone marrow suppression.
  • - Lymphocytosis > 0.5 G/L.
Inclusion criteria for Nephrology and Transplantation department:
  • - Patient with systemic lupus erythematosus (ACR classification criteria) Inclusion criteria for Neurology department: - Patient with multiple sclerosis (criteria of Mc Donald 2017) Inclusion criteria for Rheumatology Department: - Patient with rheumatoid arthritis (ACR classification criteria) Inclusion criteria for Internal Medicine-Endocrinology Department: - Patient with Basedow disease, Hashimoto's thyroiditis.
Inclusion criteria for Dermatology Department:
  • - Patient with vitiligo or alopecia areata or atopic dermatitis.

Exclusion Criteria:

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:
  • - 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.
  • - Lymphocytosis < 0.5 G/L.
Non-inclusion criteria for Rheumatology Department:
  • - Ongoing treatment with doses >15 mg/d Prednisone.
  • - Treatment with Rituximab or Tocilizumab.
  • - Ongoing treatment with JAK inhibitors.
  • - Lymphocytosis < 0.5 G/L.
Non-inclusion criteria for Internal Medicine
  • - Endocrinology Department: - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05544448
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assistance Publique - Hôpitaux de Paris
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Autoimmune Diseases, Inflammatory Disease, Acquired Bone Marrow Aplasia, Systemic Lupus Erythematosus, Multiple Sclerosis, Gvhd, Rheumatoid Arthritis, Autoimmune Thyroiditis, Vitiligo, Alopecia, Atopic Dermatitis
Additional Details

Hypothesis: In order to confirm that this differential effect of IL-2 muteins, already established in non-diseased controls, is also observed in patients with autoimmune diseases, inflammatory diseases or GVHD, a pilot in vitro study should be conducted on a small number of patient's blood samples (5 or 10 depending on the pathology). Objective : Conduct a multicentre pilot study to confirm the hypothesis that IL-2 muteins preferentially activate the STAT5 pathway in LTreg compared to LTconv in patients with GVHD, acquired bone marrow aplasia, systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, autoimmune thyroiditis, vitiligo, alopecia or atopic dermatitis. Method: At the inclusion, patients will have a blood sample collected for in vitro research purposes. Their clinical data will also be collected. Conclusion This trial should provide in vitro proof-of-principle of the efficacy of IL-2 muteins on LTreg and could eventually lead to a therapeutic trial

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Philippe REMY, MD

[email protected]

01 49 81 24 59

For additional contact information, you can also visit the trial on clinicaltrials.gov.

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

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NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

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If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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