Neuromyelitis OpticaNCT04629274
In Vitro Study of the Biological and Immunological Activity of Imotopes® Candidates on Blood Cells of Patients With Stabilized NMO
A study testing Blood sampling in people with Neuromyelitis Optica, run by Imcyse SA at 2 sites in France.
Trial summary
This is a fundamental, prospective, multi-centres, interventional non-comparative study without the administration of a study product to patients. A phase 0 study is particularly well adapted to early exploration of potential targeted treatments - i.e. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuromyelitis Optica
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jun 2020to 3 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women, 18 to 65 years of age
- Patients with a confirmed diagnosis of Neuromyelitis Optica spectrum disorders according to IPND criteria (2015) and presenting a stabilized disease (no relapse) for at least 6 months.
- Patient positive for antibodies to human aquaporin 4
- Patients having granted their written informed consent to take part in this study
Who cannot join
- Ongoing pregnancy
- Ongoing treatment with immunosuppressive agents other than those listed below under section "authorized background therapy"
- Any investigational product in the last 3 months or less than 5 times the estimated half-life of the investigational product whichever is the longer
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Pierre Wertheimer
Bron, 69500
Hôpital de Hautepierre
Strasbourg, 67200
About this study
Official title: IMCY-NMO-000 In Vitro Study of the Biological and Immunological Activity of Imotopes® Candidates on Blood Cells of Patients With Stabilized Neuromyelitis Optica (PHASE 0)
This is a fundamental, prospective, multi-centres, interventional non-comparative study without the administration of a study product to patients.
A phase 0 study is particularly well adapted to early exploration of potential targeted treatments - i.e. treatments whose efficacy can only be hoped for in patients presenting specific biological characteristics in addition to being diagnosed with the targeted disease, Neuromyelitis Optica Spectrum Disorders (NMOSD) in this study. The main goal of the study will be to support the selection of Imotopes® (i.e. synthetic peptides encompassing HLA Class II T epitopes flanked by a thioreductase motif), and (i) capable of binding with class II HLA antigens of each patient and (ii) causing ex vivo the appearance of epitope -specific cytolytic CD4+ T cells.
Read the detailed description
This is a fundamental, prospective, multi-centres, interventional non-comparative study without the administration of a study product to patients.
The objective is to test in vitro the binding of different Imotopes® to class II HLA antigens on peripheral blood mononuclear cell (PBMC) isolated from patients presenting a diagnosed and stabilized neuromyelitis optica spectrum disorders, as well as their ability to generate a cytolytic response directed against the immune cells involved in the maintenance and triggering of the disease (i.e. non-cytolytic T cells recognising the same epitopes and antigen presenting cells (APC) presenting the same epitopes).
The patients will be asked to provide at least 2 peripheral blood samples of approximately 100 milliliters each time, with a minimum of 14 days interval between these 2 samples. These blood samples will be taken by a member of the healthcare staff qualified to perform this type of procedure. If the results obtained with the 2 initial samples would be of interest to the Sponsor, the patient will be asked to come back for additional samplings with a maximum of 6 additional blood draws. The total volume of blood that will be taken over a 6 months period cannot exceed 500 milliliters with a maximum of 200 milliliters over a 30-day period for patients with a weight of min 50kg. The study has no other constraint.
The list of analysis planned to be performed on blood samples are presented below:
- Identification of the class II HLA antigens of each patient
- Study of the binding to HLA antigens of synthetic peptides
- Identification of peptides which, after binding to the HLA antigens, might induce a cytolytic response directed against the immune cells involved in the maintenance and triggering of the disease (i.e. non-cytolytic T cells recognising the same epitopes and APC presenting the same epitopes)
- Non selective genomic analysis (SNPs) in the scope of the single cell transcriptomic analysis technics
- Conditions
- Neuromyelitis Optica
- Being tested
- Blood sampling
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
The patients will be asked to provide at least 2 peripheral blood samples of approximately 100 milliliters each time, with a minimum of 14 days interval between these 2 samples.If the results obtained with the 2 initial samples would be of interest to the Sponsor, the patient will be asked to come back for additional samplings with a maximum of 6 additional blood draws
| Study group | Role | What they receive |
|---|---|---|
| Test of Imotopes® candidates on blood cells of patients with stabilized NMO | Experimental | To test in vitro the binding of different Imotopes® to class II HLA antigens on PBMC isolated from patients presenting a diagnosed and stabilized neuromyelitis optica spectrum disorders, as well as their ability to generate a cytolytic response directed against the immune cells involved in the maintenance and triggering of the disease (i.e. non-cytolytic T cells recognising the same epitopes and antigen presenting cells (APC) presenting the same epitopes). Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure in vitro binding of Imotopes®
Characterize, in vitro, the binding of different Imotopes® to class II HLA antigens on PBMC isolated from patients with NMO
Measured: Through study completion, an average of 1 year
Measure Cytolytic response against Antigen-Presenting Cells (APC)
Measure the ability of Imotopes® to generate a cytolytic response directed against the immune cells involved in the maintenance and triggering of the disease (i.e. non-cytolytic T cells recognising the same epitopes and APC presenting the same epitopes)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start15 Jun 2020
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis OpticaStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imcyse SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerome De Seze, MD, Principal investigator, Hôpital de Hautepierre, Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629274
- Sponsor's protocol ID
- IMCY-NMO-000
- Status last verified
- Jun 2024
- First submitted
- 29 Oct 2020
- Last updated
- 21 Jun 2024
- 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMCY-NMO-000 In Vitro Study of the Biological and Immunological Activity of Imotopes® Candidates on Blood Cells of Patients With Stabilized Neuromyelitis Optica (PHASE 0)
- ClinicalTrials.gov ID
- NCT04629274
- Acronym / sponsor ID
- IMCY-NMO-000
- Conditions
- Neuromyelitis Optica
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Imcyse SAIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 16 Nov 2020 (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.
This is a fundamental, prospective, multi-centres, interventional non-comparative study without the administration of a study product to patients.
A phase 0 study is particularly well adapted to early exploration of potential targeted treatments - i.e. treatments whose efficacy can only be hoped for in patients presenting specific biological characteristics in addition to being diagnosed with the targeted disease, Neuromyelitis Optica Spectrum Disorders (NMOSD) in this study. The main goal of the study will be to support the selection of Imotopes® (i.e. synthetic peptides encompassing HLA Class II T epitopes flanked by a thioreductase motif), and (i) capable of binding with class II HLA antigens of each patient and (ii) causing ex vivo the appearance of epitope -specific cytolytic CD4+ T cells.
Detailed description
This is a fundamental, prospective, multi-centres, interventional non-comparative study without the administration of a study product to patients.
The objective is to test in vitro the binding of different Imotopes® to class II HLA antigens on peripheral blood mononuclear cell (PBMC) isolated from patients presenting a diagnosed and stabilized neuromyelitis optica spectrum disorders, as well as their ability to generate a cytolytic response directed against the immune cells involved in the maintenance and triggering of the disease (i.e. non-cytolytic T cells recognising the same epitopes and antigen presenting cells (APC) presenting the same epitopes).
The patients will be asked to provide at least 2 peripheral blood samples of approximately 100 milliliters each time, with a minimum of 14 days interval between these 2 samples. These blood samples will be taken by a member of the healthcare staff qualified to perform this type of procedure. If the results obtained with the 2 initial samples would be of interest to the Sponsor, the patient will be asked to come back for additional samplings with a maximum of 6 additional blood draws. The total volume of blood that will be taken over a 6 months period cannot exceed 500 milliliters with a maximum of 200 milliliters over a 30-day period for patients with a weight of min 50kg. The study has no other constraint.
The list of analysis planned to be performed on blood samples are presented below:
- Identification of the class II HLA antigens of each patient
- Study of the binding to HLA antigens of synthetic peptides
- Identification of peptides which, after binding to the HLA antigens, might induce a cytolytic response directed against the immune cells involved in the maintenance and triggering of the disease (i.e. non-cytolytic T cells recognising the same epitopes and APC presenting the same epitopes)
- Non selective genomic analysis (SNPs) in the scope of the single cell transcriptomic analysis technics
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test of Imotopes® candidates on blood cells of patients with stabilized NMO | Experimental | Procedure: Blood samplingTo test in vitro the binding of different Imotopes® to class II HLA antigens on PBMC isolated from patients presenting a diagnosed and stabilized neuromyelitis optica spectrum disorders, as well as their ability to generate a cytolytic response directed against the immune cells involved in the maintenance and triggering of the disease (i.e. non-cytolytic T cells recognising the same epitopes and antigen presenting cells (APC) presenting the same epitopes). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women, 18 to 65 years of age
- Patients with a confirmed diagnosis of Neuromyelitis Optica spectrum disorders according to IPND criteria (2015) and presenting a stabilized disease (no relapse) for at least 6 months.
- Patient positive for antibodies to human aquaporin 4
- Patients having granted their written informed consent to take part in this study
Key exclusion criteria (3 listed)
- Ongoing pregnancy
- Ongoing treatment with immunosuppressive agents other than those listed below under section "authorized background therapy"
- Any investigational product in the last 3 months or less than 5 times the estimated half-life of the investigational product whichever is the longer
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 samplingThe patients will be asked to provide at least 2 peripheral blood samples of approximately 100 milliliters each time, with a minimum of 14 days interval between these 2 samples.If the results obtained with the 2 initial samples would be of interest to the Sponsor, the patient will be asked to come back for additional samplings with a maximum of 6 additional blood draws | Procedure or surgery | Test of Imotopes® candidates on blood cells of patients with stabilized NMO |
Primary outcome
Measure in vitro binding of Imotopes®
Time frame: Through study completion, an average of 1 year
Characterize, in vitro, the binding of different Imotopes® to class II HLA antigens on PBMC isolated from patients with NMO
Measure Cytolytic response against Antigen-Presenting Cells (APC)
Time frame: Through study completion, an average of 1 year
Measure the ability of Imotopes® to generate a cytolytic response directed against the immune cells involved in the maintenance and triggering of the disease (i.e. non-cytolytic T cells recognising the same epitopes and APC presenting the same epitopes)
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 21 Jun 2024.
- 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.
Jerome De Seze, MD principal investigator
Hôpital de Hautepierre, Strasbourg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Neuromyelitis Optica, run by Imcyse SA at 2 sites 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 4 inclusion and 3 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 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Measure in vitro binding of Imotopes® (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 21 Jun 2024.