An interventional study of Blood sample taken at a single time point in Autoimmune Diseases, Inflammatory Disease and Acquired Bone Marrow Aplasia, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Basic science
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
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
802 studies on the registry are indexed under Autoimmune Diseases; 271 are open to participants now.
This study's enrollment of 67 is above the median of 40 across 541 interventional studies indexed under Autoimmune Diseases.
Browse Autoimmune Diseases studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion criteria specific by department:
Inclusion criteria for Clinical Hematology Department:
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:
Non-inclusion criteria specific by department:
Non-inclusion criteria for Clinical Hematology Department:
Non-inclusion criteria for Nephrology and Transplantation Department:
Non-inclusion criteria for Neurology Department:
Non-inclusion criteria for Rheumatology Department:
Non-inclusion criteria for Internal Medicine - Endocrinology Department:
Non-inclusion criteria for Dermatology Department:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
At inclusion, a blood sample will be taken for research purpose
the percentage of phosphorylated STAT5 in LTresg compared to LTconv after incubation with IL-2 muteins
The measurement method is based on the quantification of the phosphorylated STAT5 molecule in LTconv and LTreg by flow cytometry after incubating the cells with IL-2 or IL-2 muteins
Time frame: At inclusion
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2023 to primary completion in Jun 2024, 8 months.
Of 77 non-industry interventional studies with no phase under Autoimmune Diseases, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 62. This study's 8 months is below that.
Counting every sponsor, half of 86 studies reached it within 31 months; a quarter within 15 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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