Relapsing Remitting Multiple SclerosisPhase 1NCT01097668
ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
A Phase 1 study testing ATX-MS-1467 in people with Relapsing Remitting Multiple Sclerosis, run by Apitope Technology (Bristol) Ltd. at 16 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- ATX-MS-1467
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Mar 2010to Jul 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 DRB115 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.
Who cannot join
- 1. Subjects treated with β-interferon, plasma exchange, intravenous gamma globulin within the 3 months prior to Study Day 1 2. Subjects treated with glatiramer acetate at any time in the past 3. Subjects who have been treated with parenteral steroids or adrenocorticotropic hormone within 3 months days prior to Study Day 1 4. Prior treatment with: cytotoxic agents (including but not limited to cladribine, mitoxantrone, cyclophosphamide, azathioprine, methotrexate), fingolimod, laquinimod, teriflunomide, total lymphoid irradiation, stem cell or bone marrow transplantation, or monoclonal antibody therapy (including natalizumab, daclizumab, alemtuzumab) 5. Prior use of disease related T-cell vaccine or peptide-tolerising agent to treat MS 6. Use of any investigational drug or experimental procedure within 6 months prior to Study Day 1 including cytokine or anti-cytokine therapy
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
Russia11 sites
Municipal Healthcare Institution "City Clinical Hospital #3", Department of neurology
Chelyabinsk, 454136
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
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
State Healthcare Institution 'Rostov Regional Clinical Hospital' Center of Neurology
Rostov-on-Don, 344015
LLC "International Clinic MEDEM", Department of functional diagnostics
Saint Petersburg, 191025
St. Petersburg State Healthcare Institution "City multifield hospital #2", Department of neurology #2
Saint Petersburg, 194354
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
Institution of the Russian Academy of Science "Institute of Human Brain of RAS", Neuroimmunology Laboratory
Saint Petersburg, 197376
State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin", Department of neurosurgery
Samara, 443095
State Educational Institution of Higher Professional Education Saratov State Medical University
Saratov, 410012
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
United Kingdom5 sites
National Hospital for Neurology & Neurosurgery
London, WC1N 3BG
Queen's Medical Centre
Nottingham, NG7 2UH
Peninsula Medical School
Plymouth, PL6 8BX
Royal Hallamshire Hospital
Sheffield, S10 2 JF
North Staffordshire Royal Infirmary
Stoke-on-Trent, Staffordshire, ST4 7LN
About this study
Official title: SAFETY AND PROOF OF PRINCIPLE STUDY OF ATX-MS-1467 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS: OPEN LABEL UPWARD TITRATION OVER FIVE DOSE LEVELS AND USING TWO ROUTES OF ADMINISTRATION (INTRADERMAL AND SUBCUTANEOUS).
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.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- ATX-MS-1467
- Keywords
- Multiple sclerosis, Immunomodulation, Phase 1
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATX-MS-1467Biological
Disease specific immune modulating treatment for multiple sclerosis
| Study group | Role | What they receive |
|---|---|---|
| Intradermal injection | Experimental | Injections will be given by the intradermal route Receives: Biological: ATX-MS-1467 |
| Subcutaneous injection | Experimental | Injections will be given by the subcutaneous route Receives: Biological: ATX-MS-1467 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Occurrence of treatment emergent Adverse Events (AE), Serious Adverse Events, and laboratory abnormalities up to week 48 compared to baseline.
Measured: 48 weeks
Secondary outcomes (1)
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.
Measured: 16 and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsing Remitting Multiple SclerosisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apitope Technology (Bristol) Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aptiv Solutions, ClinStar, LLC
- Responsible party
- Sponsor
- Investigators
- Jeremy Chataway, Principal investigator, National Hospital for Neurology and Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097668
- Sponsor's protocol ID
- ATX-MS-1467-002
- Status last verified
- Feb 2015
- First submitted
- 31 Mar 2010
- Last updated
- 16 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFETY AND PROOF OF PRINCIPLE STUDY OF ATX-MS-1467 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS: OPEN LABEL UPWARD TITRATION OVER FIVE DOSE LEVELS AND USING TWO ROUTES OF ADMINISTRATION (INTRADERMAL AND SUBCUTANEOUS).
- ClinicalTrials.gov ID
- NCT01097668
- Acronym / sponsor ID
- ATX-MS-1467-002
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Multiple sclerosis, Immunomodulation, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Apitope Technology (Bristol) Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Aptiv Solutions, ClinStar, LLC
- Study start
- Mar 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Apr 2010 (estimated)
- Results
- Posted 16 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradermal injection | Experimental | Biological: ATX-MS-1467Injections will be given by the intradermal route |
| Subcutaneous injection | Experimental | Biological: ATX-MS-1467Injections will be given by the subcutaneous route |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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 DRB115 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.
Key exclusion criteria (1 listed)
- 1. Subjects treated with β-interferon, plasma exchange, intravenous gamma globulin within the 3 months prior to Study Day 1 2. Subjects treated with glatiramer acetate at any time in the past 3. Subjects who have been treated with parenteral steroids or adrenocorticotropic hormone within 3 months days prior to Study Day 1 4. Prior treatment with: cytotoxic agents (including but not limited to cladribine, mitoxantrone, cyclophosphamide, azathioprine, methotrexate), fingolimod, laquinimod, teriflunomide, total lymphoid irradiation, stem cell or bone marrow transplantation, or monoclonal antibody therapy (including natalizumab, daclizumab, alemtuzumab) 5. Prior use of disease related T-cell vaccine or peptide-tolerising agent to treat MS 6. Use of any investigational drug or experimental procedure within 6 months prior to Study Day 1 including cytokine or anti-cytokine therapy
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 |
|---|---|---|
| ATX-MS-1467Disease specific immune modulating treatment for multiple sclerosis | Biological | Intradermal injection, Subcutaneous injection |
Primary outcome
Safety and Tolerability
Time frame: 48 weeks
Occurrence of treatment emergent Adverse Events (AE), Serious Adverse Events, and laboratory abnormalities up to week 48 compared to baseline.
1 secondary outcome
The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI).
Time frame: 16 and 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeremy Chataway principal investigator
National Hospital for Neurology and Neurosurgery
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATX-MS-1467 in people with Relapsing Remitting Multiple Sclerosis, run by Apitope Technology (Bristol) Ltd. at 16 sites in 2 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 7 inclusion and 1 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 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Russia, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 16 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety and Tolerability (time frame: 48 weeks). 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 16 Feb 2015.