Relapsing Multiple SclerosisPhase 2SIMPLIFYNCT02142192
Natalizumab Subcutaneous Immunogenicity and Safety Study
A Phase 2 study testing natalizumab in people with Relapsing Multiple Sclerosis, run by Biogen at 2 sites in Belgium.
Trial summary
The primary objective of this study is to evaluate the immunogenicity of natalizumab (BG00002) 300 mg subcutaneous (SC) administered to participants with relapsing multiple sclerosis (RMS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- natalizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Dec 2014to 4 Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 documented diagnosis of RMS at screening.
- Must fall within the therapeutic indications stated in the locally approved label for natalizumab.
- Must have an EDSS score from 0 to 6.5, inclusive.
Who cannot join
- Any prior use of natalizumab.
- Positive for anti-natalizumab antibodies at screening.
- Treatment with immunomodulatory injections (including IFN-β and glatiramer acetate) within 2 weeks prior to Screening.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis
The primary objective of this study is to evaluate the immunogenicity of natalizumab (BG00002) 300 mg subcutaneous (SC) administered to participants with relapsing multiple sclerosis (RMS). The secondary objectives of the study are to evaluate the safety of natalizumab SC injections and to evaluate the efficacy of natalizumab SC injections on relapses and on new magnetic resonance imaging (MRI) lesions.
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- natalizumab
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 | natalizumab 300mg SC every 4 weeks for up to 12 treatment administrations (i.e. Day 1 through Week 44) Receives: Drug: natalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with persistent anti-natalizumab antibodies
Persistent anti-natalizumab antibodies are defined as 2 positive anti-natalizumab test results separated by at least 6 weeks, with at least 1 positive test result occurring at or after the Week 24 Visit.
Measured: 48 weeks
Secondary outcomes (5)
Proportion of participants with transient anti-natalizumab antibodies
Measured: 48 weeks
Proportion of participants with post-injection adverse events (AEs)
Including hypersensitivity reactions, anaphylactic reactions and other AEs occurring within 1 hour after SC natalizumab dosing.
Measured: 48 weeks
Proportion of participants with clinical relapse
This may include new or enlarging T2 lesion(s), as determined by magnetic resonance imaging (MRI). Clinical relapse is defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the neurologist.
Measured: 48 weeks
Proportion of participants with gadolinium (Gd) enhancing lesion(s) as assessed by MRI.
Measured: 48 weeks
Proportion of Participants that experience Adverse Events and Serious Adverse Events
Measured: up to 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study start1 Dec 2014
- Primary completion4 Jun 2015
- Study completion4 Jun 2015
Why it stopped: Sponsor's decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple SclerosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 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
- NCT02142192
- Sponsor's protocol ID
- 101MS207
- Other IDs
- 2014-000917-30, 2014
- Acronym
- SIMPLIFY
- Status last verified
- May 2024
- First submitted
- 16 May 2014
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02142192
- Acronym / sponsor ID
- SIMPLIFY / 101MS207
- Conditions
- Relapsing Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 4 Jun 2015 (actual)
- Study completion
- 4 Jun 2015 (actual)
- First posted
- 20 May 2014 (estimated)
- 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.
The primary objective of this study is to evaluate the immunogenicity of natalizumab (BG00002) 300 mg subcutaneous (SC) administered to participants with relapsing multiple sclerosis (RMS). The secondary objectives of the study are to evaluate the safety of natalizumab SC injections and to evaluate the efficacy of natalizumab SC injections on relapses and on new magnetic resonance imaging (MRI) lesions.
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: natalizumabnatalizumab 300mg SC every 4 weeks for up to 12 treatment administrations (i.e. Day 1 through Week 44) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must have documented diagnosis of RMS at screening.
- Must fall within the therapeutic indications stated in the locally approved label for natalizumab.
- Must have an EDSS score from 0 to 6.5, inclusive.
Key exclusion criteria (4 listed)
- Any prior use of natalizumab.
- Positive for anti-natalizumab antibodies at screening.
- Treatment with immunomodulatory injections (including IFN-β and glatiramer acetate) within 2 weeks prior to Screening.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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
Proportion of participants with persistent anti-natalizumab antibodies
Time frame: 48 weeks
Persistent anti-natalizumab antibodies are defined as 2 positive anti-natalizumab test results separated by at least 6 weeks, with at least 1 positive test result occurring at or after the Week 24 Visit.
5 secondary outcomes
Proportion of participants with transient anti-natalizumab antibodies
Time frame: 48 weeks
Proportion of participants with post-injection adverse events (AEs)
Time frame: 48 weeks
Proportion of participants with clinical relapse
Time frame: 48 weeks
Proportion of participants with gadolinium (Gd) enhancing lesion(s) as assessed by MRI.
Time frame: 48 weeks
Proportion of Participants that experience Adverse Events and Serious Adverse Events
Time frame: up to 56 weeks
Results and safety
The study was stopped early (reason given: Sponsor's decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- EudraCT Tabulated ResultLink provided by the sponsor.
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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
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 natalizumab in people with Relapsing Multiple Sclerosis, run by Biogen at 2 sites in Belgium.
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 3 inclusion and 4 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 3 Jun 2024. 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 Belgium. 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 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?
The study was stopped early (reason given: Sponsor's decision.). Results are not available in the source record.
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?
Proportion of participants with persistent anti-natalizumab antibodies (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 3 Jun 2024; AzTrials last refreshed its copy on 30 Oct 2026.