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| Name | Class |
|---|---|
| Aptiv Solutions | INDUSTRY |
| ClinStar, LLC | INDUSTRY |
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Phase 1 study to assess the safety and biological activity of ATX-MS-1467 in patients with relapsing forms of multiple sclerosis. This will be an open label upward dose titration involving injections on 9 occasions, each two weeks apart. After dosing is complete there will be a 22 week follow up period. Blood samples will be drawn throughout the study to monitor safety and the body's response to the injections and MRI scans will be performed on several occasions to follow the course of the multiple sclerosis during the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intradermal injection | Experimental | Injections will be given by the intradermal route |
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| Subcutaneous injection | Experimental | Injections will be given by the subcutaneous route |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATX-MS-1467 | Biological | Disease specific immune modulating treatment for multiple sclerosis |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Occurrence of treatment emergent Adverse Events (AE), Serious Adverse Events, and laboratory abnormalities up to week 48 compared to baseline. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI). | Number of new or persisting Gadolinium-enhancing lesions at week 16 and 20 when compared to baseline. | 16 and 20 weeks |
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Inclusion Criteria:
1. Patients who have definite relapsing multiple sclerosis disease as defined by the McDonald criteria (McDonald et al., 2001 and 2005) and as assessed by a neurologist.
2. HLA DRB1*15 positive.
3. High baseline levels of T-cell proliferation in response to myelin basic protein, defined as >1000 cpm with a >3 stimulation index compared to background.
4. Disease duration equal to or less than 10 years (from the first clinical event).
5. At least one documented relapse in the previous 12 months or two relapses within the previous 24 months prior to screening.
6. Must be in a clinically stable or improving neurological state during the 28 days preceding Screening.
7. EDSS score < 5.5.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy Chataway | National Hospital for Neurology and Neurosurgery, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Municipal Healthcare Institution "City Clinical Hospital #3", Department of neurology | Chelyabinsk | 454136 | Russia | |||
Subjects were human lymphocyte antigen (HLA)-DRB1*15 positive with relapsing-remitting multiple sclerosis as defined by the McDonald criteria and as assessed by a neurologist.
Screening and study procedures were performed at hospital clinics within the United Kingdom and Russian Federation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intradermal Injection | Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days. |
| FG001 | Subcutaneous Injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| State Medical Institution "Republican Clinical Hospital of rehabilitation treatment of Ministry of Healthcare of Tatarstan Republic", Republican clinicodiagnostic center of demyelinating diseases of Ministry of Healthcare of Tatarstan Republic |
| Kazan' |
| 420021 |
| Russia |
| State Educational Institution of Higher Professional Education "1st Moscow State Medical University n.a. I.M. Sechenov of Ministry of Healthcare and Social Development of the Russian Federation, Department of new drugs research | Moscow | 119991 | Russia |
| State Healthcare Institution 'Rostov Regional Clinical Hospital' Center of Neurology | Rostov-on-Don | 344015 | Russia |
| LLC "International Clinic MEDEM", Department of functional diagnostics | Saint Petersburg | 191025 | Russia |
| St. Petersburg State Healthcare Institution "City multifield hospital #2", Department of neurology #2 | Saint Petersburg | 194354 | Russia |
| State Educational Institution of Higher Professional Education "St. Petersburg State Medical University n.a. I.V. Pavlov of Roszdrav", Department of neurology with clinic | Saint Petersburg | 197022 | Russia |
| Institution of the Russian Academy of Science "Institute of Human Brain of RAS", Neuroimmunology Laboratory | Saint Petersburg | 197376 | Russia |
| State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin", Department of neurosurgery | Samara | 443095 | Russia |
| State Educational Institution of Higher Professional Education Saratov State Medical University | Saratov | 410012 | Russia |
| State Educational Institution of Higher Professional Education "Smolensk State Medical Academy of Roszdrav", Department of neurology and neurosurgery based at State Healthcare Institution "Smolensk Regional Clinical Hospital" | Smolensk | Russia |
| North Staffordshire Royal Infirmary | Stoke-on-Trent | Staffordshire | ST4 7LN | United Kingdom |
| National Hospital for Neurology & Neurosurgery | London | WC1N 3BG | United Kingdom |
| Queen's Medical Centre | Nottingham | NG7 2UH | United Kingdom |
| Peninsula Medical School | Plymouth | PL6 8BX | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | S10 2 JF | United Kingdom |
Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days. |
| Week 20 |
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| Week 48 |
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| COMPLETED |
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| NOT COMPLETED |
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>=18 and <=55 years Gender, female and male
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| ID | Title | Description |
|---|---|---|
| BG000 | Intradermal Injection | Injections of ATX-MS-1467 given by the intradermal route |
| BG001 | Subcutaneous Injection | Injections of ATX-MS-1467 given by the subcutaneous route |
| BG002 | 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, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Safety and Tolerability | Occurrence of treatment emergent Adverse Events (AE), Serious Adverse Events, and laboratory abnormalities up to week 48 compared to baseline. | The Safety population will be denoted as the 'ITT population' for the summarisation of safety endpoints. | Posted | Number | participants | 48 weeks |
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| Secondary | The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI). | Number of new or persisting Gadolinium-enhancing lesions at week 16 and 20 when compared to baseline. | ITT population at week 16 and 20 n=21 (Intradermal injection) ITT population at week 16 and 20 n=22 (Subcutaneous injection) MRI population at week 16 and 20 n=17 (Intradermal injection) MRI population at week 16 and 20 n=20 (Subcutaneous injection) | Posted | Mean | 95% Confidence Interval | MRI lesions | 16 and 20 weeks |
|
|
Adverse event data collected over the course of the study = 52 weeks
Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.
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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 | Intradermal Injection - Treatment Emergent | Injections will be administered by the intradermal route | 1 | 21 | 17 | 21 | ||
| EG001 | Subcutaneous Injection - Treatment Emergent | Injections will be administered by the subcutaneous route | 0 | 22 | 16 | 22 | ||
| EG002 | Intradermal Injection - Non Treatment Emergent | Follow-up period | 2 | 21 | 7 | 21 | ||
| EG003 | Subcutaneous Injection - Non Treatment Emergent | Follow-up period | 1 | 22 | 5 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple Sclerosis Relapse | Nervous system disorders | MedDRA 14.0 | Systematic Assessment | Treatment emergent = onset date is on or after the date of first dosing with IMP, and the onset date does not occur after the date of the Week 20 visit. Non-treatment emergent = onset date is after the date of the Week 20 visit. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Reactions | General disorders | MedDRA 14.0 | Systematic Assessment | Treatment Emergent Adverse Event of mild to moderate intensity. |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment | Nasopharyngitis of mild to moderate intensity was experienced by 3 patients at the 800 μg dose level only (weeks 14 and 16). |
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| Respiratory Tract Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment | Emergent Adverse Events of moderate intensity. |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment | Adverse Events of mild to moderate intensity. |
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| Multiple sclerosis relapse | Nervous system disorders | MedDRA 14.0 | Systematic Assessment | Adverse Events of moderate intensity. The number of MS relapses was not unexpected for this population. |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment | Adverse Events of mild intensity. |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment | Adverse Events of moderate intensity. |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment | Subject had a TEAE assessed as moderate in severity one week after the week 14 dose. This was located on the subject's back and arm whilst the injection was on the abdomen. |
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| Anti-peptide Antibody response | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
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If the Investigator drafts a publication, he/she agrees to send it to Apitope for review and comment before its submission to the journal. If Apitope considers that the proposed publication contains patentable material or information which should be protected as valuable confidential information, Apitope reserves the right to delay submission to the journal until patent applications have been filed and/or require the deletion of the confidential information from the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Executive Officer | Apitope Technology (Bristol) Ltd | +44(0)117 3707720 | keith.martin@apitope.com |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000634284 | ATX-MS-1467 |
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| Male |
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| United Kingdom |
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