Autoimmune DiseasesMuTregNCT05544448
In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases
A study testing Blood sample taken at a single time point in people with Autoimmune Diseases and Inflammatory Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases, Inflammatory Disease, Acquired Bone Marrow Aplasia
- What is being tested?
- Blood sample taken at a single time point
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2023to 6 Jun 2024
- Phase
- Interventional
- 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
- 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
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- Lymphocytosis > 0.5 G/L
- Inclusion criteria for Nephrology and Transplantation department:
- Patient with systemic lupus erythematosus (ACR classification criteria)
- Patient with multiple sclerosis (criteria of Mc Donald 2017)
- Patient with rheumatoid arthritis (ACR classification criteria)
- Inclusion criteria for Internal Medicine-Endocrinology Department:
- Patient with Basedow disease, Hashimoto's thyroiditis
- Patient with vitiligo or alopecia areata or atopic dermatitis
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
France1 site
Hôpital Henri Mondor, 1 rue Gustave Eiffel,
Créteil, Île-de-France Region, 94000
About this study
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).
Read more
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
Read the detailed description
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
- Conditions
- Autoimmune Diseases, Inflammatory Disease, Acquired Bone Marrow Aplasia, Systemic Lupus Erythematosus, Multiple Sclerosis, Gvhd
- Being tested
- Blood sample taken at a single time point
- Keywords
- Autoimmune Diseases, Inflammation, Graft vs Host Disease, T-lymphocytes, Regulatory, Interleukin-2
- Medical subject headings
- Autoimmune Diseases, Lupus Erythematosus, Systemic, Multiple Sclerosis, Graft vs Host Disease, Arthritis, Rheumatoid, Thyroiditis, Autoimmune, Vitiligo, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample taken at a single time pointOther
At inclusion, a blood sample will be taken for research purpose
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start2 Oct 2023
- Primary completion6 Jun 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a multicenter, open-label, non-controlled, non-randomized in vitro study.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544448
- Sponsor's protocol ID
- APHP220507
- Acronym
- MuTreg
- Status last verified
- Jan 2026
- First submitted
- 14 Sep 2022
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases
- ClinicalTrials.gov ID
- NCT05544448
- Acronym / sponsor ID
- MuTreg / APHP220507
- Conditions
- Autoimmune Diseases, Inflammatory Disease, Acquired Bone Marrow Aplasia, Systemic Lupus Erythematosus, Multiple Sclerosis, Gvhd
- Keywords
- Autoimmune Diseases, Inflammation, Graft vs Host Disease, T-lymphocytes, Regulatory, Interleukin-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- This study is a multicenter, open-label, non-controlled, non-randomized in vitro study.
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample taken at a single time pointAt inclusion, a blood sample will be taken for research purpose | Other | – |
Primary outcome
the percentage of phosphorylated STAT5 in LTresg compared to LTconv after incubation with IL-2 muteins
Time frame: At inclusion
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample taken at a single time point in people with Autoimmune Diseases and Inflammatory Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 14 inclusion and 34 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 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
the percentage of phosphorylated STAT5 in LTresg compared to LTconv after incubation with IL-2 muteins (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2026.