Relapsing Remitting Multiple SclerosisPhase 4PROMPTNCT02472938
Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis
A Phase 4 study testing dimethyl fumarate in people with Relapsing Remitting Multiple Sclerosis, run by Biogen.
Trial summary
The primary objective of the study is to assess the early efficacy of treatment with BG00012 (dimethyl fumarate) 240 mg twice daily (BID) in the brain of newly diagnosed and naive-to-treatment patients with relapsing-remitting multiple sclerosis (RRMS). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- dimethyl fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jul 2020
- Phase
- Phase 4
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants with RRMS (McDonald criteria, 2010) who do not accept current injectable firstline DMTs.
- Multiple sclerosis (MS) onset within one year before enrolment
- ≥ 1 Gd+ lesions at a brain MRI scan performed within three months beforeenrolment.
- No previous disease modifying and/or immunosuppressive treatments for MS.
- Must have a baseline EDSS between 0.0 and 5.0, inclusive. · Women of childbearing potential (i.e. who are not post-menopausal for at least 1 year) and men must practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Who cannot join
- Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
- Previous disease modifying and/or immunosuppressive treatments for MS, including Tcell or T-cell receptor vaccination, any therapeutic monoclonal antibody, Mitoxantrone, Cyclophosphamide
- Previous treatment with Fumaderm®, dimethyl fumarate or other fumarates
- History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
- History of severe allergic or anaphylactic reactions or known drug hypersensitivity.Known allergy/hypersensitivity to Gadolinium.
- History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that in the opinion of the Investigator would preclude participation in a clinical trial.
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- History of or positive test result at screening for human immunodeficiency virus (HIV).Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
- History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to inclusion.
- An MS relapse that has occurred within the 30 days prior to inclusion (screening) AND/OR the subject has not stabilized from a previous relapse prior to inclusion.
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
About this study
Official title: Phase IV, Interventional, multicenteR, Double-blind, Randomized, Placebo-controlled Study tO Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With relapsingremitTing Multiple Sclerosis
The primary objective of the study is to assess the early efficacy of treatment with BG00012 (dimethyl fumarate) 240 mg twice daily (BID) in the brain of newly diagnosed and naive-to-treatment patients with relapsing-remitting multiple sclerosis (RRMS). The Secondary objectives are to establish the time course of the beneficial effect of BG00012 240 mg BID over 24 weeks and to evaluate the safety of BG00012.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- dimethyl fumarate, Placebo
- Keywords
- Relapsing remitting Multiple Sclerosis
- 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.
dimethyl fumarateDrug
Also called DMF, Tecfidera, BG00012
dimethyl fumarate 120 mg capsules
PlaceboOther
Placebo for BG00012
| Study group | Role | What they receive |
|---|---|---|
| BG00012 | Experimental | 120 mg capsule oral twice daily (BID) during the first week and 240 mg BID thereafter. Receives: Drug: dimethyl fumarate |
| Placebo | Placebo comparator | Placebo capsules orally twice a day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of cumulative combined unique active (CUA) lesions (registered from week 4 to 24)
Measured: Week 24
Secondary outcomes (4)
Mean number of CUA
Measured: at 4, 8, 12, 16, 20 and 24 weeks
Mean number of hypointense T1 lesions
Measured: at 24 weeks
New Gd+ lesions
Measured: at 4, 8, 12, 16, 20 and 24 weeks
New/enlarging T2 lesions
Measured: at 4, 8, 12, 16, 20 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 posted16 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2019 (estimated)
- Study completionJul 2020 (estimated)
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GB Pharma Services & Consulting s.r.l.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472938
- Sponsor's protocol ID
- BIIT0115
- Other IDs
- ITA-BGT-14-10682
- Acronym
- PROMPT
- Status last verified
- Dec 2015
- First submitted
- 11 May 2015
- Last updated
- 28 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Interventional, multicenteR, Double-blind, Randomized, Placebo-controlled Study tO Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With relapsingremitTing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02472938
- Acronym / sponsor ID
- PROMPT / BIIT0115
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Relapsing remitting Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- GB Pharma Services & Consulting s.r.l.
- Study start
- Jul 2015
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 16 Jun 2015 (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 the study is to assess the early efficacy of treatment with BG00012 (dimethyl fumarate) 240 mg twice daily (BID) in the brain of newly diagnosed and naive-to-treatment patients with relapsing-remitting multiple sclerosis (RRMS). The Secondary objectives are to establish the time course of the beneficial effect of BG00012 240 mg BID over 24 weeks and to evaluate the safety of BG00012.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BG00012 | Experimental | Drug: dimethyl fumarate120 mg capsule oral twice daily (BID) during the first week and 240 mg BID thereafter. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo capsules orally twice a day. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants with RRMS (McDonald criteria, 2010) who do not accept current injectable firstline DMTs.
- Multiple sclerosis (MS) onset within one year before enrolment
- ≥ 1 Gd+ lesions at a brain MRI scan performed within three months beforeenrolment.
- No previous disease modifying and/or immunosuppressive treatments for MS.
- Must have a baseline EDSS between 0.0 and 5.0, inclusive. · Women of childbearing potential (i.e. who are not post-menopausal for at least 1 year) and men must practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Key exclusion criteria (10 listed)
- Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
- Previous disease modifying and/or immunosuppressive treatments for MS, including Tcell or T-cell receptor vaccination, any therapeutic monoclonal antibody, Mitoxantrone, Cyclophosphamide
- Previous treatment with Fumaderm®, dimethyl fumarate or other fumarates
- History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
- History of severe allergic or anaphylactic reactions or known drug hypersensitivity.Known allergy/hypersensitivity to Gadolinium.
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 |
|---|---|---|
| dimethyl fumarateAlso: DMF, Tecfidera, BG00012dimethyl fumarate 120 mg capsules | Drug | BG00012 |
| PlaceboPlacebo for BG00012 | Other | Placebo |
Primary outcome
Mean number of cumulative combined unique active (CUA) lesions (registered from week 4 to 24)
Time frame: Week 24
4 secondary outcomes
Mean number of CUA
Time frame: at 4, 8, 12, 16, 20 and 24 weeks
Mean number of hypointense T1 lesions
Time frame: at 24 weeks
New Gd+ lesions
Time frame: at 4, 8, 12, 16, 20 and 24 weeks
New/enlarging T2 lesions
Time frame: at 4, 8, 12, 16, 20 and 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2015.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dimethyl fumarate in people with Relapsing Remitting Multiple Sclerosis, run by Biogen.
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 10 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: withdrawn, as of the sponsor's last update on 28 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 withdrawn before enrolling participants, so there are no results.
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?
Mean number of cumulative combined unique active (CUA) lesions (registered from week 4 to 24) (time frame: 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 28 Dec 2015.