Multiple SclerosisPhase 2AttackMSNCT05418010
Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (AttackMS)
A Phase 2 study testing Tyruko Injectable Product in people with Multiple Sclerosis and Clinically Isolated Syndrome of Demyelination, run by Queen Mary University of London at 2 sites in United Kingdom.
Trial summary
Multiple Sclerosis (MS) is a chronic inflammatory \& degenerative disease of the central nervous system (CNS) Recent data from the MS Base registry demonstrated an average delay of 152 - 215 days between first presentation and the diagnosis of MS, and more than one year until Disease Modifying Treatment (DMT) begins. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Clinically Isolated Syndrome of Demyelination
- What is being tested?
- Tyruko Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Dec 2022to 31 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Participant has provided informed consent.
- Age 18-55 years
- Participant with CIS or MS at first presentation.
- Participants show two or more lesions on T2 weighted MRI suggestive of demyelination.
- Participant is willing and able to comply with clinical visits and procedures outlined in the study protocol.
Who cannot join
- Hypersensitivity to Tyruko® or to any of the following excipients:
- Histidine
- Histidine monohydrochloride
- Sodium chloride
- Polysorbate 80 (E433)
- Water for injections
Show all 16Show fewer
- Evidence of multiple chronic demyelinating lesions on MRI without signs of recent activity.
- Participants with increased risk for opportunistic infections, including immunocompromised participants (those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies).
- Combination with other Disease Modifying Treatments..
- Known active malignancies, except for participants with cutaneous basal cell carcinoma.
- Implants such as pacemaker, aneurysm clip in the brain and MRI-incompatible prosthetic heart valves.
- Significant comorbidities such as cardiac failure, renal failure, uncontrolled diabetes and uncontrolled hypercholesterolemia.
- History of stroke, thrombosis and/or myocardial infarction.
- Any other infection deemed, in the assessment of the PI or sub-investigator, clinically significant.
- Claustrophobia
- Pregnancy or breastfeeding
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Julia Elizabeth Phillips contact
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Royal London Hospital
London, E1 1FR
Klaus Schmierer, +44 20 7882 6246, k.schmierer@qmul.ac.uk
- Recruiting
St George's Hospital
London, SW17 0QT
Liqun Zhang, liqun.zhang@stgeorges.nhs.uk
About this study
Official title: AttackMS: Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation
Multiple Sclerosis (MS) is a chronic inflammatory \& degenerative disease of the central nervous system (CNS) Recent data from the MS Base registry demonstrated an average delay of 152 - 215 days between first presentation and the diagnosis of MS, and more than one year until Disease Modifying Treatment (DMT) begins.
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.
Read the detailed description
MS is a disease of the central nervous system affecting over 130,000 people in the UK and more than 2.8 million worldwide. Left untreated, MS leads to chronic disability in the large majority of cases.
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.
- Being tested
- Tyruko Injectable Product, Placebo
- Keywords
- Multiple Sclerosis, Magnetic Resonance Imaging (MRI), Neurofilament light chain, Demyelinating Diseases, Immunologic Factors, Immune System Diseases, Autoimmune Diseases, Autoimmune Diseases of the Nervous System, Tyruko
- Medical subject headings
- Multiple Sclerosis, Charcot-Marie-Tooth disease, Type 1F, Demyelinating Diseases, Immune System Diseases, Autoimmune Diseases, Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tyruko Injectable ProductDrug
Also called Natalizumab
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.
PlaceboDrug
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®.
| Study group | Role | What they receive |
|---|---|---|
| Tyruko® 300mg | Active comparator | Tyruko® 300mg, administered via intravenous infusion in a 4 week cycle, for a total of 6 cycles Receives: Drug: Tyruko Injectable Product |
| Placebo | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish whether there is efficacy superiority of Natalizumab (Tyruko®) over placebo at 12 weeks in facilitating remyelination of previously demyelinated CNS lesions, as measured by MRI lesion magnetization transfer ratio (MTR).
Mean magnetisation transfer ratio (MTR) change in FLAIR-hyper-intense lesions at 12 weeks compared to baseline
Measured: 12 weeks
Secondary outcomes (5)
To establish whether there is a difference between participants receiving Natalizumab (Tyruko®) or placebo at 24 weeks in P100 latency measured using visually evoked potentials (VEP).
P100 latency in each eye at week 24 compared to baseline. Inter-ocular P100 latency difference at week 24 compared to baseline.
Measured: 0 and 24 weeks
To establish whether there is a difference between participants receiving Natalizumab (Tyruko®) or placebo at 24 weeks in number and occurrence of adverse events.
Measured: 24 weeks
To establish whether there is a difference between participants receiving Natalizumab (Tyruko®) or placebo at 24 weeks in facilitating remyelination of previously demyelinated CNS lesions using Magnetisation transfer ratio (MTR).
Measured: 0, 12 and/or 24 weeks
To establish whether there is a difference between participants receiving Natalizumab (Tyruko®) or placebo at 24 weeks in protecting limb function.
Serum-neurofilament light chain levels (SNfL) at week 24 compared to baseline. Expanded Disability Status Scale (EDSS) at week 24 compared to baseline. SDMT (Symbol Digit Modalities Test) score at week 24 compared to baseline. Lower Limb Function: The T25-FW (Timed 25 Foot Walk) will be collected in all pwMS. able to walk the required distance at week 24 compared to baseline.
9-HPT (Nine Hole Peg Test) at week 24 compared to baseline. NFI-MS (Neurological Fatigue Index-MS) score at week 24 compared to baseline 24 weeks.
Measured: 24 weeks
To establish whether there is a difference between participants receiving Natalizumab (Tyruko®) or placebo at 24 weeks in Retinal nerve fibre layer ganglion cell + inner plexiform (GCIP) layer thickness measured using optical coherence tomography (OCT).
Measured: O and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Dec 2022
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, placebo-controlled efficacy trial of hyperacute disease modifying treatment using Tyruko® in people with a first manifestation of central nervous system inflammatory demyelination.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen, UCL Queen Square Institute of Neurology, Moorfields Eye Hospital NHS Foundation Trust, Barts & The London NHS Trust
- Responsible party
- Sponsor
- Investigators
- Klaus Schmierer, Principal investigator, Queen Mary University of LondonLiqun Zhang, Principal investigator, St George's University Hospital NHS Foundation TrustsVictoria Singh-Curry, Principal investigator, Chelsea and Westminster Hospital Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418010
- Sponsor's protocol ID
- 1003822
- Other IDs
- 2021-002255-11
- Acronym
- AttackMS
- Status last verified
- Jan 2026
- First submitted
- 17 Feb 2022
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD data collected on the trial will be uploaded to the Pragmatic Clinical Trials Unit Safehaven and linked using pseudoanonymised participant IDs. Any further sharing of participant data to other researchers will be fully anonymised as specified at the time of participant consent.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AttackMS: Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation
- ClinicalTrials.gov ID
- NCT05418010
- Acronym / sponsor ID
- AttackMS / 1003822
- Keywords
- Multiple Sclerosis, Magnetic Resonance Imaging (MRI), Neurofilament light chain, Demyelinating Diseases, Immunologic Factors, Immune System Diseases, Autoimmune Diseases, Autoimmune Diseases of the Nervous System
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Biogen, UCL Queen Square Institute of Neurology, Moorfields Eye Hospital NHS Foundation Trust, Barts & The London NHS Trust
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 14 Jun 2022 (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.
Multiple Sclerosis (MS) is a chronic inflammatory \& degenerative disease of the central nervous system (CNS) Recent data from the MS Base registry demonstrated an average delay of 152 - 215 days between first presentation and the diagnosis of MS, and more than one year until Disease Modifying Treatment (DMT) begins.
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.
Detailed description
MS is a disease of the central nervous system affecting over 130,000 people in the UK and more than 2.8 million worldwide. Left untreated, MS leads to chronic disability in the large majority of cases.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, placebo-controlled efficacy trial of hyperacute disease modifying treatment using Tyruko® in people with a first manifestation of central nervous system inflammatory demyelination.
| Arm | Type | Receives |
|---|---|---|
| Tyruko® 300mg | Active comparator | Drug: Tyruko Injectable ProductTyruko® 300mg, administered via intravenous infusion in a 4 week cycle, for a total of 6 cycles |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant has provided informed consent.
- Age 18-55 years
- Participant with CIS or MS at first presentation.
- Participants show two or more lesions on T2 weighted MRI suggestive of demyelination.
- Participant is willing and able to comply with clinical visits and procedures outlined in the study protocol.
Key exclusion criteria (16 listed)
- Hypersensitivity to Tyruko® or to any of the following excipients:
- Evidence of multiple chronic demyelinating lesions on MRI without signs of recent activity.
- Participants with increased risk for opportunistic infections, including immunocompromised participants (those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies).
- Combination with other Disease Modifying Treatments..
- Known active malignancies, except for participants with cutaneous basal cell carcinoma.
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 |
|---|---|---|
| Tyruko Injectable ProductAlso: NatalizumabTyruko® 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. | Drug | Tyruko® 300mg |
| PlaceboPlacebo 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®. | Drug | Placebo |
Primary outcome
To establish whether there is efficacy superiority of Natalizumab (Tyruko®) over placebo at 12 weeks in facilitating remyelination of previously demyelinated CNS lesions, as measured by MRI lesion magnetization transfer ratio (MTR).
Time frame: 12 weeks
Mean magnetisation transfer ratio (MTR) change in FLAIR-hyper-intense lesions at 12 weeks compared to baseline
5 secondary outcomes
To establish whether there is a difference between participants receiving Natalizumab (Tyruko®) or placebo at 24 weeks in P100 latency measured using visually evoked potentials (VEP).
Time frame: 0 and 24 weeks
To establish whether there is a difference between participants receiving Natalizumab (Tyruko®) or placebo at 24 weeks in number and occurrence of adverse events.
Time frame: 24 weeks
To establish whether there is a difference between participants receiving Natalizumab (Tyruko®) or placebo at 24 weeks in facilitating remyelination of previously demyelinated CNS lesions using Magnetisation transfer ratio (MTR).
Time frame: 0, 12 and/or 24 weeks
To establish whether there is a difference between participants receiving Natalizumab (Tyruko®) or placebo at 24 weeks in protecting limb function.
Time frame: 24 weeks
To establish whether there is a difference between participants receiving Natalizumab (Tyruko®) or placebo at 24 weeks in Retinal nerve fibre layer ganglion cell + inner plexiform (GCIP) layer thickness measured using optical coherence tomography (OCT).
Time frame: O and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- AttackMS AbstractLink provided by the sponsor.
- CI Interview: AttackMS assessing the feasibility of multiple sclerosis treatment within 14 days of presentationLink provided by the sponsor.
- Multiple Sclerosis Academy Webinar on AttackMSLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD data collected on the trial will be uploaded to the Pragmatic Clinical Trials Unit Safehaven and linked using pseudoanonymised participant IDs. Any further sharing of participant data to other researchers will be fully anonymised as specified at the time of participant consent.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
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.
Julia Elizabeth Phillips contact
Klaus Schmierer principal investigator
Queen Mary University of London
Liqun Zhang principal investigator
St George's University Hospital NHS Foundation Trusts
Victoria Singh-Curry principal investigator
Chelsea and Westminster Hospital Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tyruko Injectable Product in people with Multiple Sclerosis and Clinically Isolated Syndrome of Demyelination, run by Queen Mary University of London at 2 sites in United Kingdom.
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 5 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Klaus Schmierer (+44 20 7882 6246, k.schmierer@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish whether there is efficacy superiority of Natalizumab (Tyruko®) over placebo at 12 weeks in facilitating remyelination of previously demyelinated CNS lesions, as measured by MRI lesion magnetization transfer ratio (MTR). (time frame: 12 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 7 Jan 2026.