NCT04629274Completed
In Vitro Study of the Biological and Immunological Activity of Imotopes® Candidates on Blood Cells of Patients With Stabilized NMO
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)
Source: ClinicalTrials.gov · Last updated 21 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 29 Oct 2020
- Start date
- 15 Jun 2020
- Primary completion date
- 3 Jun 2024
- Lead sponsor
- Imcyse SA
- Diseases
- Neuromyelitis optica (NMOSD)
- NCT number
- NCT04629274
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 15 Jun 2020 to the primary completion date, 3 Jun 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Ongoing pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Pierre Wertheimer Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| Hôpital de Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.