Type 1 Diabetes MellitusPhase 1NCT03272269
Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes
A Phase 1 study testing IMCY-0098 in people with Type 1 Diabetes Mellitus, run by Imcyse SA at 17 sites in 7 countries.
Trial summary
This clinical study will evaluate the safety of an innovative approach expected to be disease-modifying by stopping the auto-immune-mediated destruction of islet β-cells in the pancreas. Three doses of the investigational product will be tested in successive cohorts. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- IMCY-0098
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 17 sitesin 7 countries
- Study dates
- 23 Aug 2017to 30 Aug 2019
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female 18 to 30 years of age
- Initial diagnosis of Type 1 diabetes according to ADA/WHO criteria within the past 6 months
- Insulin requirement, as determined by the investigator
- Presence of at least one autoantibody (GAD65, IA-2, or ZnT8)
- Fasting C-peptide at screening >0.2 nmol/L and/or stimulated C-peptide ≥ 0,4 nmol/L.
- HLADR3-positive and/or HLADR4-positive
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- Willingness to undergo the insulin treatment prescribed by the physician
- Body mass index (BMI) between 17-28 kg/m2 at screening
- Fully informed written consent obtained
- Males with reproductive potential should use barrier method of contraception (condom) from screening up to 90 days after last treatment with investigational product.
- Women of childbearing potential should use an highly effective contraception method from screening and for the whole duration of the study.
Who cannot join
- Ongoing or planned pregnancy during the whole duration of the study or lactation
- Presence of significant medical conditions in particular chronic liver condition, chronic hematological disease, renal dysfunction of grade 2 or more according to the World Health Organization (WHO) Toxicity Scale .
- Has any current signs or symptoms of infection at entry or within 2 weeks of entry or has received intravenous antibiotics within 2 months prior to the first planned administration of the study product
- Has received any live, attenuated vaccine within 3 months prior to the first planned administration of the study product (i.e. oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, Japanese encephalitis vaccine, dengue vaccine, rotavirus vaccine, varicella vaccine, live-attenuated zoster vaccine, Bacillus Calmette-Guérin [BCG] vaccine, oral typhoid vaccine)
- History of, or current malignancy (except excised basal cell skin cancer)
- Clinical evidence of a diabetes-related complication that could interfere with patient's participation/completion of study
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- Primary or secondary immune deficiency disorders
- Human Immunodeficiency virus (HIV), chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Presence at screening of abnormal laboratory values grade 2 or more according to the World Health Organization (WHO) Toxicity Scale
- Anti-diabetic treatments other than insulin in the week prior to first study drug administration
- Ongoing treatment with immunosuppressive agents or treatment within the past year with the exception of topical or intra nasal corticosteroids.
- Treatment with immunotherapy within the past 3 months
- Treatment with an investigational drug within the past 3 months
- Patients with a known hypersensitivity to any component of the drug product should be excluded from the study
- Patients under treatment with statins at the time of screening.
Trial locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
United Kingdom7 sites
Cambridge University Hospitals NHS Foundation Trust
Cambridge
Cardiff University
Cardiff
Royal Devon and Exeter NHS Trust
Exeter
Guy's and St. Thomas NHS Trust
London
St. Bartholomew's Hospital (Barts Health NHS Trust)
London
Newcastle University
Newcastle upon Tyne
Oxford University Hospitals NHS Foundation Trust
Oxford
Lithuania2 sites
Klaipeda University Hospital
Klaipėda
University Hospital Santaros Klinikos
Vilnius
About this study
Official title: A Phase I Placebo-controlled, Double-blind, Dose Escalation Clinical Trial to Evaluate the Safety and Immune Responses of Imcyse's IMCY-0098 in Patients With Recent Onset Type 1 Diabetes
This clinical study will evaluate the safety of an innovative approach expected to be disease-modifying by stopping the auto-immune-mediated destruction of islet β-cells in the pancreas. Three doses of the investigational product will be tested in successive cohorts. Although safety is the first objective of this study, we will gather efficacy data and perform a set of immunological tests to further understand the mechanism of action of this new approach in young adults with recent onset type 1 diabetes.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- IMCY-0098, Placebo
- Keywords
- Diabetes Mellitus type 1, Autoimmune disease, Immunotherapy, Diabetes treatment, Residual beta cell function, Adult patients
- Medical subject headings
- Diabetes Mellitus, Type 1, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMCY-0098Drug
Also called Imotope
Small synthetic peptide for SC admin. Solvent: alum hydroxide
PlaceboOther
Solvent: alum hydroxide
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, low dose | Experimental | 4 SC injections of IMCY-0098 or Placebo Receives: Drug: IMCY-0098; Other: Placebo |
| Cohort 2, medium dose | Experimental | 4 SC injections of IMCY-0098 or Placebo Receives: Drug: IMCY-0098; Other: Placebo |
| Cohort 3, high dose | Experimental | 4 SC injections of IMCY-0098 or Placebo Receives: Drug: IMCY-0098; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all adverse events reported for subjects
Safety assessed through measurement and comparison of any reactions or hypersensitivity to IMCY-0098 injection vs placebo. Number of adverse events will also be compared between groups with the addition of safety monitoring blood tests
Measured: up to 24 weeks
Secondary outcomes (1)
Assessment of residual beta cell function and markers of metabolic control
Measured by a change in stimulated C-peptide production, daily insulin usage, glycated haemoglobin levels and glucose levels and excursions from baseline and between groups
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start23 Aug 2017
- Primary completion17 Apr 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imcyse SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre Vandepapelière, MD, Study director, Imcyse SAChristian Boitard, MD, Principal investigator, Hôpital Cochin, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272269
- Sponsor's protocol ID
- IMCY-T1D-001
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2017
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carlier VA, VanderElst L, Janssens W, Jacquemin MG, Saint-Remy JM. Increased synapse formation obtained by T cell epitopes containing a CxxC motif in flanking residues convert CD4+ T cells into cytolytic effectors. PLoS One. 2012;7(10):e45366. doi: 10.1371/journal.pone.0045366. Epub 2012 Oct 9.
PubMed 23056200Malek Abrahimians E, Carlier VA, Vander Elst L, Saint-Remy JM. MHC Class II-Restricted Epitopes Containing an Oxidoreductase Activity Prompt CD4(+) T Cells with Apoptosis-Inducing Properties. Front Immunol. 2015 Sep 2;6:449. doi: 10.3389/fimmu.2015.00449. eCollection 2015.
PubMed 26388872Malek Abrahimians E, Vander Elst L, Carlier VA, Saint-Remy JM. Thioreductase-Containing Epitopes Inhibit the Development of Type 1 Diabetes in the NOD Mouse Model. Front Immunol. 2016 Mar 2;7:67. doi: 10.3389/fimmu.2016.00067. eCollection 2016.
PubMed 26973647Van Rampelbergh J, Achenbach P, Leslie RD, Kindermans M, Parmentier F, Carlier V, Bovy N, Vanderelst L, Van Mechelen M, Vandepapeliere P, Boitard C. First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes: an exploratory analysis of immune biomarkers. BMC Med. 2024 Jun 21;22(1):259. doi: 10.1186/s12916-024-03476-y.
PubMed 38902652Van Rampelbergh J, Achenbach P, Leslie RD, Ali MA, Dayan C, Keymeulen B, Owen KR, Kindermans M, Parmentier F, Carlier V, Ahangarani RR, Gebruers E, Bovy N, Vanderelst L, Van Mechelen M, Vandepapeliere P, Boitard C. First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes. BMC Med. 2023 May 24;21(1):190. doi: 10.1186/s12916-023-02900-z.
PubMed 37226224
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Placebo-controlled, Double-blind, Dose Escalation Clinical Trial to Evaluate the Safety and Immune Responses of Imcyse's IMCY-0098 in Patients With Recent Onset Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03272269
- Acronym / sponsor ID
- IMCY-T1D-001
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Diabetes Mellitus type 1, Autoimmune disease, Immunotherapy, Diabetes treatment, Residual beta cell function, Adult patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Imcyse SAIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 5 Sep 2017 (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 clinical study will evaluate the safety of an innovative approach expected to be disease-modifying by stopping the auto-immune-mediated destruction of islet β-cells in the pancreas. Three doses of the investigational product will be tested in successive cohorts. Although safety is the first objective of this study, we will gather efficacy data and perform a set of immunological tests to further understand the mechanism of action of this new approach in young adults with recent onset type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, low dose | Experimental | Drug: IMCY-0098, Other: Placebo4 SC injections of IMCY-0098 or Placebo |
| Cohort 2, medium dose | Experimental | Drug: IMCY-0098, Other: Placebo4 SC injections of IMCY-0098 or Placebo |
| Cohort 3, high dose | Experimental | Drug: IMCY-0098, Other: Placebo4 SC injections of IMCY-0098 or Placebo |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female 18 to 30 years of age
- Initial diagnosis of Type 1 diabetes according to ADA/WHO criteria within the past 6 months
- Insulin requirement, as determined by the investigator
- Presence of at least one autoantibody (GAD65, IA-2, or ZnT8)
- Fasting C-peptide at screening >0.2 nmol/L and/or stimulated C-peptide ≥ 0,4 nmol/L.
Key exclusion criteria (15 listed)
- Ongoing or planned pregnancy during the whole duration of the study or lactation
- Presence of significant medical conditions in particular chronic liver condition, chronic hematological disease, renal dysfunction of grade 2 or more according to the World Health Organization (WHO) Toxicity Scale .
- Has any current signs or symptoms of infection at entry or within 2 weeks of entry or has received intravenous antibiotics within 2 months prior to the first planned administration of the study product
- Has received any live, attenuated vaccine within 3 months prior to the first planned administration of the study product (i.e. oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, Japanese encephalitis vaccine, dengue vaccine, rotavirus vaccine, varicella vaccine, live-attenuated zoster vaccine, Bacillus Calmette-Guérin [BCG] vaccine, oral typhoid vaccine)
- History of, or current malignancy (except excised basal cell skin cancer)
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 |
|---|---|---|
| IMCY-0098Also: ImotopeSmall synthetic peptide for SC admin. Solvent: alum hydroxide | Drug | Cohort 1, low dose, Cohort 2, medium dose, Cohort 3, high dose |
| PlaceboSolvent: alum hydroxide | Other | Cohort 1, low dose, Cohort 2, medium dose, Cohort 3, high dose |
Primary outcome
Incidence of all adverse events reported for subjects
Time frame: up to 24 weeks
Safety assessed through measurement and comparison of any reactions or hypersensitivity to IMCY-0098 injection vs placebo. Number of adverse events will also be compared between groups with the addition of safety monitoring blood tests
1 secondary outcome
Assessment of residual beta cell function and markers of metabolic control
Time frame: up to 24 weeks
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 6 Sep 2019.
- Background: PubMed 23056200Carlier VA, VanderElst L, Janssens W, Jacquemin MG, Saint-Remy JM. Increased synapse formation obtained by T cell epitopes containing a CxxC motif in flanking residues convert CD4+ T cells into cytolytic effectors. PLoS One. 2012;7(10):e45366. doi: 10.1371/journal.pone.0045366. Epub 2012 Oct 9.
- Background: PubMed 26388872Malek Abrahimians E, Carlier VA, Vander Elst L, Saint-Remy JM. MHC Class II-Restricted Epitopes Containing an Oxidoreductase Activity Prompt CD4(+) T Cells with Apoptosis-Inducing Properties. Front Immunol. 2015 Sep 2;6:449. doi: 10.3389/fimmu.2015.00449. eCollection 2015.
- Background: PubMed 26973647Malek Abrahimians E, Vander Elst L, Carlier VA, Saint-Remy JM. Thioreductase-Containing Epitopes Inhibit the Development of Type 1 Diabetes in the NOD Mouse Model. Front Immunol. 2016 Mar 2;7:67. doi: 10.3389/fimmu.2016.00067. eCollection 2016.
- Derived from this study: PubMed 38902652Van Rampelbergh J, Achenbach P, Leslie RD, Kindermans M, Parmentier F, Carlier V, Bovy N, Vanderelst L, Van Mechelen M, Vandepapeliere P, Boitard C. First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes: an exploratory analysis of immune biomarkers. BMC Med. 2024 Jun 21;22(1):259. doi: 10.1186/s12916-024-03476-y.
- Derived from this study: PubMed 37226224Van Rampelbergh J, Achenbach P, Leslie RD, Ali MA, Dayan C, Keymeulen B, Owen KR, Kindermans M, Parmentier F, Carlier V, Ahangarani RR, Gebruers E, Bovy N, Vanderelst L, Van Mechelen M, Vandepapeliere P, Boitard C. First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes. BMC Med. 2023 May 24;21(1):190. doi: 10.1186/s12916-023-02900-z.
- Registre belge du diabèteLink provided by the sponsor.
- Belgisch diabetes registerLink provided by the sponsor.
- Research study for people with Type 1 Diabetes: EXALTLink provided by the sponsor.
- 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.
Pierre Vandepapelière, MD study director
Imcyse SA
Christian Boitard, MD principal investigator
Hôpital Cochin, Paris, France
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMCY-0098 in people with Type 1 Diabetes Mellitus, run by Imcyse SA at 17 sites in 7 countries.
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 15 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom, Belgium, Lithuania, Sweden, Denmark and 2 more countries. 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?
Incidence of all adverse events reported for subjects (time frame: up to 24 weeks). 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 NCT03272269, which also lists 5 linked publications.
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 6 Sep 2019.