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AzTrials

Amyotrophic Lateral SclerosisPhase 2IMODALSNCT02059759

Immuno-modulation in Amyotrophic Lateral Sclerosis- a Phase II Study of Safety and Activity of Low Dose Interleukin-2

A Phase 2 study testing 1.0 MIU IL-2 per day and 2.0 MIU IL-2 per day in people with Amyotrophic Lateral Sclerosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective is to evaluate in ALS patients the regulatory T cell early response to two low-doses of IL-2 at 1 and 2 MIU per day after one course of 5 consecutive days comparatively to placebo. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Amyotrophic Lateral Sclerosis
What is being tested?
1.0 MIU IL-2 per day and 2.0 MIU IL-2 per day
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteFrance
Study dates
Sep 2015to 25 May 2016
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has been correctly informed
  • The patient must have given his/her informed and signed consent.
  • The patient must be insured or beneficiary of a health insurance plan.
  • The patient is at least 18 years old and less than 75 years old
  • Probable, or laboratory-supported probable or definite ALS as defined by El Escorial Revised ALS diagnostic criteria (according to Airlie House Conference 1988)
  • Stable on riluzole treatment for more than 3 months with liver function test results < 2ULN
Show all 11Show fewer
  • Disease duration ≤ 5 years
  • Vital capacity ≥ 70% of normal
  • Ability to swallow without the requirement for nasogastric or PEG feeding
  • Agreement for patient to use an adequate method of contraception throughout the study and for 2 weeks after post study visit
  • The patient is available and willing to participate in seven study visits occurring at the CHU within the next six months

Who cannot join

  • The patient is participating in another interventional study
  • Within the past three months, the patient has participated in another interventional
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection
  • The patient is an adult under guardianship
  • The patient refuses to sign the consent
Show all 20Show fewer
  • It is impossible to correctly inform the patient
  • Other life threatening disease
  • Presence of contra-indicated concomitant treatments or with potential neuroprotective benefit (see section 11.2 of the protocol)
  • Presence of tracheostomy or non-invasive ventilation
  • Use of Percutaneous endoscopic gastrostomy (PEG) or nasogastric tube
  • Presence of clinical infection (treated or untreated)
  • Positive serology for CMV, EBV (confirmed by viral load), or HIV
  • Vaccination within 8 weeks prior to first experimental dosing
  • Other disease precluding functional assessments
  • Cancer within the past 5 years (except stable non-metastatic basal cell skin carcinoma or in situ carcinoma of the cervix)
  • Severe cardiac or pulmonary disease
  • Documented auto-immune disorders except asymptomatic Hashimoto thyroiditis
  • Women of child bearing age without contraception or pregnant or breast feeding
  • Any clinically significant laboratory abnormality (excepting cholesterol, triglyceride and glucose)

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHRU de Montpellier - Hôpital Gui de Chauliac

    Montpellier, 34295

Other trials in France

About this study

The primary objective is to evaluate in ALS patients the regulatory T cell early response to two low-doses of IL-2 at 1 and 2 MIU per day after one course of 5 consecutive days comparatively to placebo.

Read the detailed description

This is a phase II study on ld-IL-2 as a therapeutic agent for ALS which aims at defining the activity and safety of a range a doses for subsequent use of the best dose in a phase II/III trial. For ethical reasons, ld-IL-2 must be tested as an add-on therapy to riluzole hence all patients will need to be treated with riluzole for at least three months prior to entry. A randomized (1:1:1), placebo-controlled, double-blind, parallel group trial will be carried out to assess ld-IL-2 activity on regulatory T cells and immuno-inflammatory markers in ALS patients treated for 3 months (5 days every four weeks repeated three times).

The secondary objectives of this study are:

  1. To evaluate maintenance of Tcell response after three repeated 5-day courses at one course every four weeks for 12 weeks.
  2. To evaluate the safety of ld-IL-2 therapy in an ALS population, with an overall follow-up of 6 months (up to 15 weeks after last administration); C. To evaluate functional changes throughout the study; D. To evaluate changes in other pre-defined blood cytology parameters, and a blood biomarker for axonal damage.
Being tested
Placebo, 1.0 MIU IL-2 per day, 2.0 MIU IL-2 per day
Keywords
low-dose interleukin 2
Medical subject headings
Amyotrophic Lateral Sclerosis

What participants receive

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

  • PlaceboDrug

    Patients in this arm will receive sub-cutaneous injections of placebo (same vehicle as for experimental arms, and same volume) for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).

  • 1.0 MIU IL-2 per dayDrug

    Also called Aldesleukine, Proleukin

    Patients in this arm will receive sub-cutaneous injections corresponding to 1.0 MIU of IL-2 per injection for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).

  • 2.0 MIU IL-2 per dayDrug

    Also called Aldesleukine, Proleukin

    Patients in this arm will receive sub-cutaneous injections corresponding to 2.0 MIU of IL-2 per injection for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).

Study groups in NCT02059759
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPatients in this arm will receive sub-cutaneous injections of placebo (same vehicle as for experimental arms, and same volume) for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months). Intervention: Placebo
Receives: Drug: Placebo
1.0 IL-2ExperimentalPatients in this arm will receive sub-cutaneous injections corresponding to 1.0 MIU of IL-2 per injection for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months). Intervention: 1.0 MIU IL-2 per day
Receives: Drug: 1.0 MIU IL-2 per day
2.0 IL-2ExperimentalPatients in this arm will receive sub-cutaneous injections corresponding to 2.0 MIU of IL-2 per injection for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months). Intervention: 2.0 MIU IL-2 per day
Receives: Drug: 2.0 MIU IL-2 per day

What is being measured

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

  1. CD4+ CD25+ CD127- FoxP3+(Treg) cells: change in percentage of total lymphocytes

    Treg refers to regulatory T cells

    Measured: Day 8

Secondary outcomes (83)

  1. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 1

  2. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 2

  3. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 3

  4. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 4

  5. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 5

  6. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 6

  7. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 7

  8. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 8

  9. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 29

  10. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 30

  11. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 31

  12. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 32

  13. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 33

  14. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 34

  15. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 35

  16. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 36

  17. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 57

  18. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 58

  19. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 59

  20. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 60

  21. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 61

  22. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 62

  23. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 63

  24. Presence/absence of specific, pre-defined adverse events.

    The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.

    Measured: Day 64

  25. Presence/absence of abnormal vital signs

    (based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)

    Measured: Day 1

  26. Presence/absence of abnormal vital signs

    (based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)

    Measured: Day 8

  27. Presence/absence of abnormal vital signs

    (based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)

    Measured: Day 29

  28. Presence/absence of abnormal vital signs

    (based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)

    Measured: Day 57

  29. Presence/absence of abnormal vital signs

    (based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)

    Measured: Day 64

  30. Presence/absence of abnormal vital signs

    (based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)

    Measured: Week 13

  31. Presence/absence of abnormal vital signs

    (based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)

    Measured: Week 25

  32. MedDRA classification of all adverse events throughout the study

    MedDRA refers to "Medical Dictionary for Regulatory Activities"

    Measured: Week 25

  33. Thyroid function: blood T4

    Measured: Baseline (day 0 to day -15)

  34. Thyroid function: blood T4

    Measured: Week 13

  35. Thyroid function: blood TSH

    Measured: Baseline (day 0 to day -15)

  36. Thyroid function: blood TSH

    Measured: Week 13

  37. Presence/absence of clinically significant abnormality on a lung x-ray

    Measured: Baseline (day 0 to day -15)

  38. Presence/absence of clinically significant abnormality on a lung x-ray

    Measured: Week 13

  39. Presence/absence of clinically significant abnormality on an electrocardiogram

    Measured: Baseline (day 0 to day -15)

  40. Presence/absence of clinically significant abnormality on an electrocardiogram

    Measured: Week 13

  41. Presence/absence of a clinically significant abnormality among routine laboratory tests

    The routine blood tests considered are:

    • haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration )
    • blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)
    • liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)
    • iron metabolism (iron, ferritin, transferrin)

    Measured: Day 1

  42. Presence/absence of a clinically significant abnormality among routine laboratory tests

    The routine blood tests considered are:

    • haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)
    • blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)
    • liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)
    • iron metabolism (iron, ferritin, transferrin)

    Measured: Day 8

  43. Presence/absence of a clinically significant abnormality among routine laboratory tests

    The routine blood tests considered are:

    • haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)
    • blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)
    • liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)
    • iron metabolism (iron, ferritin, transferrin)

    Measured: Day 29

  44. Presence/absence of a clinically significant abnormality among routine laboratory tests

    The routine blood tests considered are:

    • haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)
    • blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)
    • liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)
    • iron metabolism (iron, ferritin, transferrin)

    Measured: Day 57

  45. Presence/absence of a clinically significant abnormality among routine laboratory tests

    The routine blood tests considered are:

    • haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)
    • blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)
    • liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)
    • iron metabolism (iron, ferritin, transferrin)

    Measured: Day 64

  46. Presence/absence of a clinically significant abnormality among routine laboratory tests

    The routine blood tests considered are:

    • haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)
    • blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)
    • liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)
    • iron metabolism (iron, ferritin, transferrin)

    Measured: Week 13

  47. Presence/absence of a clinically significant abnormality among routine laboratory tests

    The routine blood tests considered are:

    • haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)
    • blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)
    • liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)
    • iron metabolism (iron, ferritin, transferrin)

    Measured: Week 25

  48. Vital capacity (% of normal)

    This is a measure of respiratory function.

    Measured: Baseline (day 0 to day -15)

  49. Vital capacity (% of normal)

    This is a measure of respiratory function.

    Measured: Day 1

  50. Vital capacity (% of normal)

    This is a measure of respiratory function.

    Measured: Week 13

  51. Vital capacity (% of normal)

    This is a measure of respiratory function.

    Measured: Week 25

  52. The ALSFRS Questionnaire

    Measured: Day 1

  53. The ALSFRS Questionnaire

    Measured: Day 29

  54. The ALSFRS Questionnaire

    Measured: Day 57

  55. The ALSFRS Questionnaire

    Measured: Week 13

  56. The ALSFRS Questionnaire

    Measured: Week 25

  57. Tregs (absolute number and % CF4+ cells)

    Measured: Day 1

  58. Tregs (absolute number and % CF4+ cells)

    Measured: Day 8

  59. Tregs (absolute number and % CF4+ cells)

    Measured: Day 57

  60. Tregs (absolute number and % CF4+ cells)

    Measured: Day 64

  61. Tregs (absolute number and % CF4+ cells)

    Measured: Week 13

  62. Tregs (absolute number and % CF4+ cells)

    Measured: Week 25

  63. Total lymphocyte number

    Measured: Day 1

  64. Total lymphocyte number

    Measured: Day 8

  65. Total lymphocyte number

    Measured: Day 57

  66. Total lymphocyte number

    Measured: Day 64

  67. Total lymphocyte number

    Measured: Week 13

  68. Total lymphocyte number

    Measured: Week 25

  69. CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes

    Measured: Day 1

  70. CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes

    Measured: Day 8

  71. CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes

    Measured: Day 57

  72. CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes

    Measured: Day 64

  73. CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes

    Measured: Week 13

  74. CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes

    Measured: week 25

  75. effector T cells: number and % of CD4 cells

    This is measured as CD4+ lymphocytes minus regulatory T cells

    Measured: Day 1

  76. effector T cells: number and % of CD4 cells

    This is measured as CD4+ lymphocytes minus regulatory T cells

    Measured: Day 8

  77. effector T cells: number and % of CD4 cells

    This is measured as CD4+ lymphocytes minus regulatory T cells

    Measured: Day 57

  78. effector T cells: number and % of CD4 cells

    This is measured as CD4+ lymphocytes minus regulatory T cells

    Measured: Day 64

  79. effector T cells: number and % of CD4 cells

    This is measured as CD4+ lymphocytes minus regulatory T cells

    Measured: Week 13

  80. effector T cells: number and % of CD4 cells

    This is measured as CD4+ lymphocytes minus regulatory T cells

    Measured: Week 25

  81. Phosphorylated neurofilament heavy protein (pNfH) levels in serum

    Measured: day 1

  82. Light chain neurofilament levels in serum

    Measured: Day 1

  83. Light chain neurofilament levels in serum

    Measured: Week 13

Timeline

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

  1. First posted11 Feb 2014 (estimated)
  2. Study startSep 2015
  3. Primary completion25 May 2016
  4. Study completion25 May 2016

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02059759
Sponsor's protocol ID
LOCAL/2014/WC-01
Other IDs
2014-001327-71, 2014
Acronym
IMODALS
Status last verified
Nov 2025
First submitted
7 Feb 2014
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Camu W, Mickunas M, Veyrune JL, Payan C, Garlanda C, Locati M, Juntas-Morales R, Pageot N, Malaspina A, Andreasson U, Kirby J, Suehs C, Saker S, Masseguin C, De Vos J, Zetterberg H, Shaw PJ, Al-Chalabi A, Leigh PN, Tree T, Bensimon G. Repeated 5-day cycles of low dose aldesleukin in amyotrophic lateral sclerosis (IMODALS): A phase 2a randomised, double-blind, placebo-controlled trial. EBioMedicine. 2020 Sep;59:102844. doi: 10.1016/j.ebiom.2020.102844. Epub 2020 Jul 7.

    PubMed 32651161

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 1.0 MIU IL-2 per day and 2.0 MIU IL-2 per day in people with Amyotrophic Lateral Sclerosis, run by Centre Hospitalier Universitaire de Nīmes 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 11 inclusion and 20 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 17 Nov 2025. 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. Some participants in this study may receive a placebo. 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?

CD4+ CD25+ CD127- FoxP3+(Treg) cells: change in percentage of total lymphocytes (time frame: Day 8). 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 NCT02059759, 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 17 Nov 2025.

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