Multiple Sclerosis, Relapsing-RemittingPhase 3NCT05265728
A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered Subcutaneously to Japanese Participants With Relapsing-Remitting Multiple Sclerosis
A Phase 3 study testing Natalizumab in people with Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 12 sites in Japan.
Trial summary
The primary objective of this study is to evaluate the efficacy of natalizumab 300 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) administrations up to 24 weeks in Japanese participants with relapsing-remitting multiple sclerosis (RRMS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Natalizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 12 sitesJapan
- Study dates
- 26 Apr 2022to 27 May 2024
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have had a diagnosis of RRMS, as defined by the revised 2017 McDonald's criteria. All other possible neurologic diagnoses must have been reasonably excluded by means of laboratory and/or imaging studies, in the opinion of the investigator.
- Must have had an EDSS score between 0.0 and 5.5, inclusive.
- Must have had screening MRI or documentation of an MRI within the participant's medical record within 12 months of the screening visit that revealed 3 or more T2 hyperintense lesions consistent with MS.
- Was born in Japan, and biological parents and grandparents were of Japanese origin.
Who cannot join
- Evidence of current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 14 days prior to Screening, between screening and baseline visit, or at baseline visit, including but not limited to a fever (temperature > 37.5 degrees Celsius [°C]), new and persistent cough, breathlessness, or loss of taste and/or smell.
- Have close contact within 14 days prior to Day 1 with a SARS-CoV-2 positive individual.
- Diagnosis of primary progressive MS or secondary progressive MS.
- An MS exacerbation (relapse) within 30 days prior to enrolment or, in the opinion of the investigator, the participant not having stabilized from a previous relapse prior to enrolment (Day 1).
- The participant is unable to have a brain MRI scan (e.g., a participant with a metal clip to repair a cerebral aneurysm).
- Previous exposure to natalizumab.
- Note: Other protocol specified Inclusion/Exclusion criteria may apply.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Japan12 sites
Juntendo University Hospital
Bunkyō City, 113-8431
Chiba University Hospital
Chiba, 260-8677
St.Marianna University Hospital
Kawasaki-shi, 216-8511
National Center of Neurology and Psychiatry
Kodaira-shi, 187-8551
Kansai Medical University Medical Center
Moriguchi-shi, 570-8507
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Ebara Hospital
Ōta-ku, 145-0065
The Kitasato Institute Kitasato University Hospital
Sagamihara-shi, 252-0375
National Hospital Organization Hokkaido Medical Center
Sapporo, 063-0005
Tohoku Medical and Pharmaceutical University Hospital
Sendai, 983-8512
Osaka University Hospital
Suita-shi, 565-0871
University of Tsukuba Hospital
Tsukuba, 305-8576
Tokyo Women's Medical University Yachiyo Medical Center
Yachiyo-shi, 276-8524
About this study
Official title: A Single-Arm, Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered to Japanese Participants With Relapsing-Remitting Multiple Sclerosis Via a Subcutaneous Route of Administration
The primary objective of this study is to evaluate the efficacy of natalizumab 300 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) administrations up to 24 weeks in Japanese participants with relapsing-remitting multiple sclerosis (RRMS).
The secondary objectives of the study are to evaluate other clinical and magnetic resonance imaging (MRI) measures of efficacy of natalizumab 300 mg SC Q4W administrations in Japanese participants with RRMS, to evaluate the safety, tolerability, and immunogenicity of natalizumab 300 mg SC Q4W administrations up to 48 weeks in Japanese participants with RRMS, to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of natalizumab 300 mg SC Q4W administrations up to 24 weeks and for an additional 24 weeks in Japanese participants with RRMS.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Natalizumab
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatalizumabDrug
Also called BG00002, Tysabri
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Natalizumab | Experimental | Participants will receive natalizumab 300 mg SC Q4W for 48 weeks. Receives: Drug: Natalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Cumulative Number of New Active Lesions up to Week 24 Identified Using Brain Magnetic Resonance Imaging (MRI) Scans
New active lesions were defined as the sum of gadolinium (Gd)-enhancing lesions and non-enhancing new or newly enlarging T2 hyperintense lesions over a period of 24 weeks.
Measured: Up to Week 24
Secondary outcomes (20)
Part 2: Cumulative Number of New Active Lesions up to Week 48 Identified Using Brain MRI Scans
New active lesions were defined as the sum of Gd-enhancing lesions and non-enhancing new or newly enlarging T2 hyperintense lesions over a period of 48 weeks.
Measured: Up to Week 48
Part 1: Proportion of Participants With Any New Active Lesions at Week 24 Identified Using Brain MRI Scans
New active lesions were defined as the sum of gadolinium-enhancing lesions and non-enhancing new or newly enlarging T2 hyperintense lesions.
Measured: At Week 24
Part 2: Proportion of Participants With Any New Active Lesions at Week 48 Identified Using Brain MRI Scans
New active lesions were defined as the sum of Gd-enhancing lesions and non-enhancing new or newly enlarging T2 hyperintense lesions.
Measured: At Week 48
Change From Baseline in Number of Gd-Enhancing Lesions at Week 24 and Week 48
Measured: Baseline, Weeks 24 and 48
Number of Non-enhancing New or Newly Enlarging T2 Hyperintense Lesions at Week 24
Measured: At Week 24
Number of Non-enhancing New or Newly Enlarging T2 Hyperintense Lesions at Week 48
Measured: At Week 48
Number of New T1 Hypointense Lesions at Week 24
Measured: At Week 24
Number of New T1 Hypointense Lesions at Week 48
Measured: At Week 48
Annualized Relapse Rate (ARR) at Week 24, Week 48 and Week 52
ARR is calculated as the total number of relapses that occurred during the treatment period divided by the total number of participant-years. ARR was analyzed using negative binomial regression model.
Measured: At Week 24, Week 48 and Week 52
Proportion of Relapse-Free Participants at Week 24 and Week 52
A multiple sclerosis (MS) relapse was defined as the onset of new or recurrent neurological symptoms lasting at least 24 hours, accompanied by new objective abnormalities on a neurological examination, and not explained solely by non-MS processes such as fever, infection, severe stress, or drug toxicity.
Measured: At Week 24 and Week 52
Visual Analog Scale (VAS) Score at Week 24 and Week 48
The participant's global impression of his/her well-being was assessed with a VAS. The instrument ranges from 0 to 100 millimeters (mm), where a score of 0 denotes 'poor' and a score of 100 denotes 'excellent'. Higher scores indicates a better health state.
Measured: At Week 24 and Week 48
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as any AE that has an onset date and time that is on or after the date and time of the first dose of study treatment, or that has worsened after the date and time of the first dose of study treatment through 84 days after the last dose of study treatment.
Measured: From first dose of study drug through 84 days after the last dose of study drug (up to Week 60)
Percentage of Participants With Positive Anti-John Cunningham Virus (Anti-JCV) Antibodies
Measured: Baseline up to Week 48
Number of Participants With Injection Site Reactions and Injection Reactions
Measured: From first dose of study drug through 84 days after the last dose of study drug (up to Week 60)
Percentage of Participants With Positive Anti-Natalizumab Antibodies
Measured: Baseline up to Week 48
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Week 24 and Week 48
The EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory and cerebral functions, as well as walking ability. It measures the MS disability status on a scale ranging from 0 (normal) to 10 (death due to MS), with higher scores indicating more disability. A negative change from baseline indicates an improvement in the disability.
Measured: Baseline, Week 24 and Week 48
Serum Trough Concentration (Ctrough) of Natalizumab
Measured: Pre-dose at Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Serum Concentration of Natalizumab Between Day 6 and Day 8
One blood sample was collected between Day 6 and Day 8.
Measured: Between Day 6 and Day 8
Trough Alpha-4 (α4) Integrin Saturation
Measured: Pre-dose at Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Serum Soluble VCAM-1 Concentrations
Measured: Pre-dose at Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start26 Apr 2022
- Primary completion18 Jan 2024
- Study completion27 May 2024
Why it stopped: Due to sponsor decision, not for efficacy or safety reasons.
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 Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by BiogenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265728
- Sponsor's protocol ID
- 101MS330
- Status last verified
- Nov 2025
- First submitted
- 23 Feb 2022
- Last updated
- 25 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered to Japanese Participants With Relapsing-Remitting Multiple Sclerosis Via a Subcutaneous Route of Administration
- ClinicalTrials.gov ID
- NCT05265728
- Acronym / sponsor ID
- 101MS330
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to sponsor decision, not for efficacy or safety reasons.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Posted 25 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy of natalizumab 300 milligrams (mg) subcutaneous (SC) every 4 weeks (Q4W) administrations up to 24 weeks in Japanese participants with relapsing-remitting multiple sclerosis (RRMS).
The secondary objectives of the study are to evaluate other clinical and magnetic resonance imaging (MRI) measures of efficacy of natalizumab 300 mg SC Q4W administrations in Japanese participants with RRMS, to evaluate the safety, tolerability, and immunogenicity of natalizumab 300 mg SC Q4W administrations up to 48 weeks in Japanese participants with RRMS, to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of natalizumab 300 mg SC Q4W administrations up to 24 weeks and for an additional 24 weeks in Japanese participants with RRMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Natalizumab | Experimental | Drug: NatalizumabParticipants will receive natalizumab 300 mg SC Q4W for 48 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must have had a diagnosis of RRMS, as defined by the revised 2017 McDonald's criteria. All other possible neurologic diagnoses must have been reasonably excluded by means of laboratory and/or imaging studies, in the opinion of the investigator.
- Must have had an EDSS score between 0.0 and 5.5, inclusive.
- Must have had screening MRI or documentation of an MRI within the participant's medical record within 12 months of the screening visit that revealed 3 or more T2 hyperintense lesions consistent with MS.
- Was born in Japan, and biological parents and grandparents were of Japanese origin.
Key exclusion criteria (7 listed)
- Evidence of current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 14 days prior to Screening, between screening and baseline visit, or at baseline visit, including but not limited to a fever (temperature > 37.5 degrees Celsius [°C]), new and persistent cough, breathlessness, or loss of taste and/or smell.
- Have close contact within 14 days prior to Day 1 with a SARS-CoV-2 positive individual.
- Diagnosis of primary progressive MS or secondary progressive MS.
- An MS exacerbation (relapse) within 30 days prior to enrolment or, in the opinion of the investigator, the participant not having stabilized from a previous relapse prior to enrolment (Day 1).
- The participant is unable to have a brain MRI scan (e.g., a participant with a metal clip to repair a cerebral aneurysm).
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 |
|---|---|---|
| NatalizumabAlso: BG00002, TysabriAdministered as specified in the treatment arm | Drug | Natalizumab |
Primary outcome
Part 1: Cumulative Number of New Active Lesions up to Week 24 Identified Using Brain Magnetic Resonance Imaging (MRI) Scans
Time frame: Up to Week 24
New active lesions were defined as the sum of gadolinium (Gd)-enhancing lesions and non-enhancing new or newly enlarging T2 hyperintense lesions over a period of 24 weeks.
20 secondary outcomes
Part 2: Cumulative Number of New Active Lesions up to Week 48 Identified Using Brain MRI Scans
Time frame: Up to Week 48
Part 1: Proportion of Participants With Any New Active Lesions at Week 24 Identified Using Brain MRI Scans
Time frame: At Week 24
Part 2: Proportion of Participants With Any New Active Lesions at Week 48 Identified Using Brain MRI Scans
Time frame: At Week 48
Change From Baseline in Number of Gd-Enhancing Lesions at Week 24 and Week 48
Time frame: Baseline, Weeks 24 and 48
Number of Non-enhancing New or Newly Enlarging T2 Hyperintense Lesions at Week 24
Time frame: At Week 24
Number of Non-enhancing New or Newly Enlarging T2 Hyperintense Lesions at Week 48
Time frame: At Week 48
Number of New T1 Hypointense Lesions at Week 24
Time frame: At Week 24
Number of New T1 Hypointense Lesions at Week 48
Time frame: At Week 48
Annualized Relapse Rate (ARR) at Week 24, Week 48 and Week 52
Time frame: At Week 24, Week 48 and Week 52
Proportion of Relapse-Free Participants at Week 24 and Week 52
Time frame: At Week 24 and Week 52
Visual Analog Scale (VAS) Score at Week 24 and Week 48
Time frame: At Week 24 and Week 48
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: From first dose of study drug through 84 days after the last dose of study drug (up to Week 60)
Percentage of Participants With Positive Anti-John Cunningham Virus (Anti-JCV) Antibodies
Time frame: Baseline up to Week 48
Number of Participants With Injection Site Reactions and Injection Reactions
Time frame: From first dose of study drug through 84 days after the last dose of study drug (up to Week 60)
Percentage of Participants With Positive Anti-Natalizumab Antibodies
Time frame: Baseline up to Week 48
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Week 24 and Week 48
Time frame: Baseline, Week 24 and Week 48
Serum Trough Concentration (Ctrough) of Natalizumab
Time frame: Pre-dose at Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Serum Concentration of Natalizumab Between Day 6 and Day 8
Time frame: Between Day 6 and Day 8
Trough Alpha-4 (α4) Integrin Saturation
Time frame: Pre-dose at Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Serum Soluble VCAM-1 Concentrations
Time frame: Pre-dose at Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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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.
Medical Director study director
Biogen
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Natalizumab in people with Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 12 sites in Japan.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 25 Nov 2025). 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?
Part 1: Cumulative Number of New Active Lesions up to Week 24 Identified Using Brain Magnetic Resonance Imaging (MRI) Scans (time frame: Up to Week 24). 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 25 Nov 2025.