Healthy VolunteersPhase 1HEALTHIL-2NCT03837093
Low-dose IL-2 to the Kinetics of Regulatory T-cell in Healthy Volunteers
A Phase 1 study testing ILT101 in people with Healthy Volunteers, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate the safety and the dose-response relationship of ILT-101 to blood Tregs. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ILT101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2019to 6 Nov 2021
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Without any chronic diseases diagnosed (including allergies);
- Effective contraception> 2 weeks before the first administration of the experimental drug or its placebo and β-hCG negative at the verification of the selection criteria;
- Affiliated to a social security system;
- Free, informed and written consent, signed by the subject and the investigator, before any action required by the research.
- Not taking any treatment
Who cannot join
- Subject in a period of exclusion of participation in other biomedical research;
- Participation in another research ≤ 1 month and during the study except for research Transimmunom (Non-interventional research involving the human person);
- known antecedents of autoimmune diseases;
- Hypersensitivity to any of the excipients of the investigational drug (mannitol, sodium laurilsulfate, monosodium phosphate dihydrate, disodium phosphate dihydrate);
- Evolutionary infection requiring treatment;
- Viral infection and benign infection less than 2 months old;
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- Venous capital not allowing blood samples;
- Pregnant or lactating women;
- Men and women of childbearing potential without effective contraception during the study;
- Live attenuated virus vaccination in the month prior to inclusion or during the study;
- Surgical intervention ≤ 2 months or planned during the study;
- Psychiatric pathology or drug addiction that may impair ability to comply with protocol requirements or give informed consent;
- Presence or history of cancer that has not been cured for less than 5 years, except in situ cervical cancer, or basocellular cancer;
- Subject under a legal protection measure.
Trial locations and contacts
1 site in 1 country.
France1 site
Clinical Investigation Center Paris Est Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris
Paris, 75013
About this study
Official title: A Study of the Dose-response Relationship of Low-dose IL-2 to the Kinetics of Regulatory T-cell Response in Healthy Volunteers
The purpose of this study is to evaluate the safety and the dose-response relationship of ILT-101 to blood Tregs.
Read the detailed description
In the healthy physiological state, there is homeostasis between regulatory T cells (Tregs) and effector T cells (Teffs) which is deregulated in autoimmune diseases (AID).
The existence of an AID indicates a lack of Tregs. Our team has discovered that low-dose interleukin-2 (ld-IL2) activates and specifically increases Tregs in humans and thus may improve AID. Exploiting this potential requires i) to better target the dose with the best benefit / risk ratio and also ii) to better understand the mechanism of action of this molecule through clinical trials of ld-IL2 in progress, including in type 1 diabetes, multiple sclerosis and systemic lupus erythematosus. During these clinical trials, a very thorough immunological follow-up is carried out in order to discover biomarkers of treatment efficacy. Exploitation of these results will benefit both the cross-analysis of the effects of IL-2 in these 3 diseases with distinct pathophysiologies, but also very importantly a comparison with the effects of ld-IL2 at the healthy volunteer. These analyzes should make it possible to define the most effective dose of IL-2.
- Conditions
- Healthy Volunteers
- Being tested
- ILT101, Placebo
- Keywords
- Low dose of IL-2, Healthy volunteers, Kinetic study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILT101Drug
Also called low-dose IL-2
Subcutaneous injections starting with induction course with once-daily administration for 5 consecutive days, followed by maintenance course with once every weeks administration during three weeks
PlaceboDrug
Subcutaneous injections starting with induction course with once-daily administration for 5 consecutive days, followed by maintenance course with once every weeks administration during three weeks
| Study group | Role | What they receive |
|---|---|---|
| dose A | Experimental | ILT-101 Receives: Drug: ILT101 |
| dose B | Experimental | ILT-101 Receives: Drug: ILT101 |
| dose C | Experimental | ILT-101 Receives: Drug: ILT101 |
| dose D | Experimental | ILT-101 Receives: Drug: ILT101 |
| dose E | Experimental | ILT-101 Receives: Drug: ILT101 |
| Placebo | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of Tregs(in (expressed in % of CD4 and total)
Measured: from Day 1 to Day 5
Secondary outcomes (7)
AUC corresponding to the évolution of residual values of tregs/CD4+
Measured: Day 5 to Day 60
numbers of different circulating immune populations
Measured: baseline to Day 60
levels of serum cytokine(pg)
Measured: from baseline to Day 60
levels of serum chemokine
Measured: from baseline to Day 60
composition of the intestinal microbiota
Measured: from baseline to Day 60
adverse events, anti IL-2 autoantibodies
Measured: from baseline to Day 60
levels of serum anti-IL-2 autoantibodies
Measured: from baseline to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start6 Jun 2019
- Primary completion3 Mar 2021
- Study completion6 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Iltoo Pharma
- Responsible party
- Sponsor
- Investigators
- David Klatzmann, MD, Principal investigator, Investigation Center in Biotherapy et immunology Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris l'hopital 75013 ParisRoberta Lorenzon, MD, Study director, Clinical Investigation Center Paris Est Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837093
- Sponsor's protocol ID
- APHP180274
- Other IDs
- 2018-004123-37, MEDAECNAT-2018-11-0048, 2-17-33, 2018
- Acronym
- HEALTHIL-2
- Status last verified
- Dec 2021
- First submitted
- 17 Jan 2019
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Dose-response Relationship of Low-dose IL-2 to the Kinetics of Regulatory T-cell Response in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03837093
- Acronym / sponsor ID
- HEALTHIL-2 / APHP180274
- Conditions
- Healthy Volunteers
- Keywords
- Low dose of IL-2, Healthy volunteers, Kinetic study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Iltoo Pharma
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 6 Nov 2021 (actual)
- First posted
- 11 Feb 2019 (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.
The purpose of this study is to evaluate the safety and the dose-response relationship of ILT-101 to blood Tregs.
Detailed description
In the healthy physiological state, there is homeostasis between regulatory T cells (Tregs) and effector T cells (Teffs) which is deregulated in autoimmune diseases (AID).
The existence of an AID indicates a lack of Tregs. Our team has discovered that low-dose interleukin-2 (ld-IL2) activates and specifically increases Tregs in humans and thus may improve AID. Exploiting this potential requires i) to better target the dose with the best benefit / risk ratio and also ii) to better understand the mechanism of action of this molecule through clinical trials of ld-IL2 in progress, including in type 1 diabetes, multiple sclerosis and systemic lupus erythematosus. During these clinical trials, a very thorough immunological follow-up is carried out in order to discover biomarkers of treatment efficacy. Exploitation of these results will benefit both the cross-analysis of the effects of IL-2 in these 3 diseases with distinct pathophysiologies, but also very importantly a comparison with the effects of ld-IL2 at the healthy volunteer. These analyzes should make it possible to define the most effective dose of IL-2.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| dose A | Experimental | Drug: ILT101ILT-101 |
| dose B | Experimental | Drug: ILT101ILT-101 |
| dose C | Experimental | Drug: ILT101ILT-101 |
| dose D | Experimental | Drug: ILT101ILT-101 |
| dose E | Experimental | Drug: ILT101ILT-101 |
| Placebo | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Without any chronic diseases diagnosed (including allergies);
- Effective contraception> 2 weeks before the first administration of the experimental drug or its placebo and β-hCG negative at the verification of the selection criteria;
- Affiliated to a social security system;
- Free, informed and written consent, signed by the subject and the investigator, before any action required by the research.
- Not taking any treatment
Key exclusion criteria (14 listed)
- Subject in a period of exclusion of participation in other biomedical research;
- Participation in another research ≤ 1 month and during the study except for research Transimmunom (Non-interventional research involving the human person);
- known antecedents of autoimmune diseases;
- Hypersensitivity to any of the excipients of the investigational drug (mannitol, sodium laurilsulfate, monosodium phosphate dihydrate, disodium phosphate dihydrate);
- Evolutionary infection requiring treatment;
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 |
|---|---|---|
| ILT101Also: low-dose IL-2Subcutaneous injections starting with induction course with once-daily administration for 5 consecutive days, followed by maintenance course with once every weeks administration during three weeks | Drug | dose A, dose B, dose C, dose D, dose E |
| PlaceboSubcutaneous injections starting with induction course with once-daily administration for 5 consecutive days, followed by maintenance course with once every weeks administration during three weeks | Drug | Placebo |
Primary outcome
Variation of Tregs(in (expressed in % of CD4 and total)
Time frame: from Day 1 to Day 5
7 secondary outcomes
AUC corresponding to the évolution of residual values of tregs/CD4+
Time frame: Day 5 to Day 60
numbers of different circulating immune populations
Time frame: baseline to Day 60
levels of serum cytokine(pg)
Time frame: from baseline to Day 60
levels of serum chemokine
Time frame: from baseline to Day 60
composition of the intestinal microbiota
Time frame: from baseline to Day 60
adverse events, anti IL-2 autoantibodies
Time frame: from baseline to Day 60
levels of serum anti-IL-2 autoantibodies
Time frame: from baseline to Day 60
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 30 Dec 2021.
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Pain
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.
David Klatzmann, MD principal investigator
Investigation Center in Biotherapy et immunology Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris l'hopital 75013 Paris
Roberta Lorenzon, MD study director
Clinical Investigation Center Paris Est Hôpital Universitaire Pitié-Salpêtrière 83 bd de l'Hôpital 75013 Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ILT101 in people with Healthy Volunteers, 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 5 inclusion and 14 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 30 Dec 2021. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Variation of Tregs(in (expressed in % of CD4 and total) (time frame: from Day 1 to Day 5). 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 30 Dec 2021.