Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (AttackMS)
NCT ID: NCT05418010
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2022-12-01
2027-10-31
Brief Summary
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Evidence suggests that shutting down inflammation using highly effective DMTs early after diagnosis leads to better long term clinical outcomes The AttackMS trial will test the effect of starting a highly-effective DMT licensed for MS, Tyruko® (Natalizumab 300mg), within a short time - 14 days - after symptom onset.
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Detailed Description
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CIS is a common first manifestation of MS: There is a more than 80% chance of MS in somebody presenting with CIS provided one or more "lesions" characteristic of inflammatory demyelination can be detected on a magnetic resonance imaging (MRI) of the brain. The presence of at least two such lesions is an inclusion criterion for this study. Inflammatory demyelination is the process by which cells of your body's own immune system attack the insulation sheath (= myelin) of nerve fibres (= axons) in the central nervous system.
Once a diagnosis of MS has been confirmed, many people with this disease will be eligible for what is called "disease-modifying treatment" (DMT) on the NHS. Such treatment targets the immune cells that are involved in the inflammatory attack against the myelin sheaths and nerve fibres. However, while in a small number of cases, a diagnosis of MS can be made instantaneously it regularly takes week, months and, sometimes even longer, to fulfil the formal diagnostic criteria of MS. This diagnostic delay inevitably leads to delays in starting disease-modifying treatment.
Using a trial concept geared towards rapid assessment of eligibility, and a disease-modifying treatment that is both highly effective and generally well tolerated in people with MS, AttackMS will test whether:
(i) It is feasible to recruit participants with a diagnosis of CIS at high risk of MS, or definite MS, at first presentation for treatment within 14 days of symptom onset and (ii) Such early treatment improves myelin repair at 3 months, as measured using a special MRI technology called magnetisation transfer ratio (MTR).
Natalizumab (Tyruko®) is a medication currently approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as a disease-modifying treatment for adults with rapidly evolving severe (RES) relapsing MS. We are looking to test safety and efficacy of treatment with Tyruko® 300mg, given through a needle in a vein (intravenous infusion), over 20 weeks and to advance mechanistic understanding in treating people with first presentation of CIS or MS.
AttackMS will test the effect of starting a highly-effective DMT licensed for MS, Tyruko®, within a short time - 14 days - after symptom onset. The main objective is to test Tyruko®, given intravenously every 4 weeks over 20 weeks, for safety, efficacy, and to advance the mechanistic understanding of the earliest events in inflammatory demyelination/MS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tyruko® 300mg
Tyruko® 300mg, administered via intravenous infusion in a 4 week cycle, for a total of 6 cycles
Tyruko Injectable Product
Tyruko® is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis. Tyruko® 300mg concentrate for solution for infusion and matching placebo are collectively referred to as IMP when detailing to blinded trial procedures. Tyruko® 300mg will be colourless, clear to slightly opalescent solution.
Placebo
Placebo, administered via intravenous infusion in a 4 week cycle, for 3 cycles, followed by Tyruko® 300mg, administered via intravenous infusion for a total of 3 cycles
Placebo
Placebo is colourless, clear to slightly opalescent liquid. The formulation of the is the same as that of commercial Tyruko® minus the active ingredient. Placebo is in the same containers/vials as Tyruko®.
Interventions
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Tyruko Injectable Product
Tyruko® is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis. Tyruko® 300mg concentrate for solution for infusion and matching placebo are collectively referred to as IMP when detailing to blinded trial procedures. Tyruko® 300mg will be colourless, clear to slightly opalescent solution.
Placebo
Placebo is colourless, clear to slightly opalescent liquid. The formulation of the is the same as that of commercial Tyruko® minus the active ingredient. Placebo is in the same containers/vials as Tyruko®.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 18-55 years
3. Participant with CIS or MS at first presentation.
4. Participants show two or more lesions on T2 weighted MRI suggestive of demyelination.
5. Participant is willing and able to comply with clinical visits and procedures outlined in the study protocol.
Exclusion Criteria
* Histidine
* Histidine monohydrochloride
* Sodium chloride
* Polysorbate 80 (E433)
* Water for injections
2. Evidence of multiple chronic demyelinating lesions on MRI without signs of recent activity.
3. Participants with increased risk for opportunistic infections, including immunocompromised participants (those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies).
4. Combination with other Disease Modifying Treatments..
5. Known active malignancies, except for participants with cutaneous basal cell carcinoma.
6. Implants such as pacemaker, aneurysm clip in the brain and MRI-incompatible prosthetic heart valves.
7. Significant comorbidities such as cardiac failure, renal failure, uncontrolled diabetes and uncontrolled hypercholesterolemia.
8. History of stroke, thrombosis and/or myocardial infarction.
9. Any other infection deemed, in the assessment of the PI or sub-investigator, clinically significant.
10. Claustrophobia
11. Pregnancy or breastfeeding
18 Years
55 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
UCL Queen Square Institute of Neurology
OTHER
Moorfields Eye Hospital NHS Foundation Trust
OTHER
Barts & The London NHS Trust
OTHER
Queen Mary University of London
OTHER
Responsible Party
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Principal Investigators
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Klaus Schmierer
Role: PRINCIPAL_INVESTIGATOR
Queen Mary University of London
Liqun Zhang
Role: PRINCIPAL_INVESTIGATOR
St George's University Hospital NHS Foundation Trusts
Victoria Singh-Curry
Role: PRINCIPAL_INVESTIGATOR
Chelsea and Westminster Hospital Foundation Trust
Locations
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Royal London Hospital
London, , United Kingdom
St George's Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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AttackMS Abstract
CI Interview: AttackMS assessing the feasibility of multiple sclerosis treatment within 14 days of presentation
Multiple Sclerosis Academy Webinar on AttackMS
Other Identifiers
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2021-002255-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1003822
Identifier Type: -
Identifier Source: org_study_id
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