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This study is the follow-up of study IMCY-T1D 001 (EudraCT: 2016-003514-27, NCT03272269) in which patients with recent onset T1D have been treated with IMCY-0098 or placebo.
At the end of the primary 6 month study, patients will be proposed to enter this follow-up study to evaluate up to 12 months (V3 - Week 48) the safety, the immune responses and the clinical parameters.
The study involves a follow-up of 6 months after the end of the initial participation to the IMCY-T1D-001 study. Subjects will undergo visits at 24 weeks, 36 weeks and 48 weeks post first study product administration in study IMCY-T1D-001.
For each patient, the study comprises a total of 3 visits occurring over a period of approximately 24 weeks (from study entry). The patients will undergo planned assessments and procedures as outlined in the table of study procedures.
In this Long-Term Follow-Up (LTFU) study, the below objectives will be assessed 36 and 48 weeks after the first injection of IMCY-0098 in the study IMCY-T1D-001, in patients treated with IMCY-0098 at three doses or placebo:
Primary Objective The primary objective of this study is to assess the long-term safety. Secondary Objective The secondary objective of this study is to evaluate the clinical response to IMCY-0098 by assessing disease activity.
Exploratory Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follow-up | Placebo Comparator | No Investigational Medicinal Product (IMP) will be administered during this LTFU study. Patients received treatment with IMCY-0098 in the primary study (IMCY-T1D-001). |
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| IMCY_0098 | Experimental | No Investigational Medicinal Product (IMP) will be administered during this LTFU study. Patients received treatment with IMCY-0098 in the primary study (IMCY-T1D-001). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMCY-0098 or placebo | Drug | Long-term follow-up |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Throughout the study period (24weeks) | |
| Serious Adverse Events | Throughout the study period (24 weeks) |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Van Rampelbergh, PhD | Imcyse SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Erasme | Brussels | Belgium | ||||
| UZ Brussel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37226224 | Derived | Van 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Patients having received 50 μg IMP (2x subcutaneous [s.c.] injections of 25 μg [100 μL each]) + 3x 25 μg IMP (each as 2x s.c. injections of 12.5 μg [50 μL each]) in study 2016-003514-27 |
| FG001 | Cohort 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 23, 2021 |
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Long-term follow-up (LTFU), no study treatment administered.
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Treatment or Placebo
| Brussels |
| Belgium |
| UZ Gent | Ghent | Belgium |
| Bispebjerg and Frederiksberg Hospital | Copenhagen | Denmark |
| Hôpital Cochin | Paris | France |
| GWT-TUD GmbH | Dresden | Germany |
| Helmholtz Zentrum München - Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH) | München | Germany |
| Hospital of Lithuanian University of Health Sciences Kauno klinikos | Kaunas | Lithuania |
| Klaipeda University Hospital | Klaipėda | Lithuania |
| University Hospital Santaros Klinikos | Vilnius | Lithuania |
| Clinical Trial Center, CTC | Gothenburg | Sweden |
| ProbarE Stockholm | Stockholm | Sweden |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | United Kingdom |
| Cardiff University | Cardiff | United Kingdom |
| Royal Devon and Exeter NHS Trust | Exeter | United Kingdom |
| Guy's and St. Thomas NHS Trust | London | United Kingdom |
| St. Bartholomew's Hospital (Barts Health NHS Trust) | London | United Kingdom |
| Newcastle University | Newcastle upon Tyne | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Oxford | United Kingdom |
Patients having received 150 μg IMP (2x s.c. injections of 75 μg [300 μL each]) + 3x 75 μg IMP (each as 2x s.c injections of 12.5 μg [150 μL each]) in study 2016-003514-27
| FG002 | Cohort 3 | Patients having received 450 μg IMP (2x s.c. injections of 225 μg [900 μL each]) + 3x 225 μg IMP (each as 2x s.c injections of 112.5 μg [450 μL each]) in study 2016-003514-27 |
| FG003 | Placebo | Patients having received Placebo in study 2016-003514-27 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Patients having received 50 μg IMP (2x subcutaneous [s.c.] injections of 25 μg [100 μL each]) + 3x 25 μg IMP (each as 2x s.c. injections of 12.5 μg [50 μL each]) in study 2016-003514-27 |
| BG001 | Cohort 2 | Patients having received 150 μg IMP (2x s.c. injections of 75 μg [300 μL each]) + 3x 75 μg IMP (each as 2x s.c injections of 12.5 μg [150 μL each]) in study 2016-003514-27 |
| BG002 | Cohort 3 | Patients having received 450 μg IMP (2x s.c. injections of 225 μg [900 μL each]) + 3x 225 μg IMP (each as 2x s.c injections of 112.5 μg [450 μL each]) in study 2016-003514-27 |
| BG003 | Placebo | Patients having received Placebo in study 2016-003514-27 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events | Posted | Number | Number of AE | Throughout the study period (24weeks) |
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| Primary | Serious Adverse Events | Posted | Number | Number of SAE | Throughout the study period (24 weeks) |
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Throughout the study period (24 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Patients having received 50 μg IMP (2x subcutaneous [s.c.] injections of 25 μg [100 μL each]) + 3x 25 μg IMP (each as 2x s.c. injections of 12.5 μg [50 μL each]) in study 2016-003514-27 | 0 | 4 | 0 | 4 | 2 | 4 |
| EG001 | Cohort 2 | Patients having received 150 μg IMP (2x s.c. injections of 75 μg [300 μL each]) + 3x 75 μg IMP (each as 2x s.c injections of 12.5 μg [150 μL each]) in study 2016-003514-27 | 0 | 7 | 0 | 7 | 3 | 7 |
| EG002 | Cohort 3 | Patients having received 450 μg IMP (2x s.c. injections of 225 μg [900 μL each]) + 3x 225 μg IMP (each as 2x s.c injections of 112.5 μg [450 μL each]) in study 2016-003514-27 | 0 | 12 | 0 | 12 | 6 | 12 |
| EG003 | Placebo | Patients having received Placebo in study 2016-003514-27 | 0 | 7 | 0 | 7 | 2 | 7 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foreign body in eye | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Sports injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Peripheral swelling | General disorders | Non-systematic Assessment |
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| Adbominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
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| Depression | Psychiatric disorders | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | Non-systematic Assessment |
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| Genital rash | Reproductive system and breast disorders | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | Non-systematic Assessment |
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| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
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| Bacterial infection | Infections and infestations | Non-systematic Assessment |
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| Fungal ski infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean Van Rampelbergh | Imcyse SA | +3243251100 | j.vanrampelbergh@imcyse.com |
| Dec 23, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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