Relapsing Multiple SclerosisPhase 2NCT04079088
Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-β1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS)
A Phase 2 study testing BIIB061, Interferon-beta1 and Glatiramer acetate in people with Relapsing Multiple Sclerosis, run by Biogen.
Trial summary
The primary objectives of the study are to evaluate the safety of BIIB061 versus placebo in participants with Relapsing Multiple Sclerosis (RMS), and to evaluate the efficacy of BIIB061 to improve disability outcome versus placebo in participants with RMS. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- BIIB061, Interferon-beta1 and Glatiramer acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2021to 18 Sep 2024
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS)
- Have a Baseline Expanded Disability Status Scale (EDSS) score of 2.0 to 6.0
- Have a MS disease duration of ≤20 years from first MS symptom(s)
- Must have at least one of the following occurring within 12 months prior to
- Day 1/Baseline:
- ≥1 clinical relapse(s) or objective disability worsening (as per treating neurologist's judgment) (b) ≥1 Gadolinium (Gd)-enhancing T1 lesion(s) on brain or spinal cord Magnetic Resonance Imaging (MRI) (c) ≥1 new T2 lesion(s) on brain or spinal cord MRI (the reference scan used to detect new T2 lesion formation has to be ≤12 months prior to Day 1/Baseline)
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- Must have been taking one of the following disease-modifying therapy (DMTs) at a stable dose for at least 12 weeks prior to Day 1/Baseline:
- Interferon-beta1 (IFN-β1): Avonex, Plegridy, Betaferon/Betaseron, Extavia, or Rebif
- Glatiramer acetate (Copaxone or Glatopa).
Who cannot join
- A documented history of clinically significant persistent neutralizing antibody against IFN-β1 (applicable only for participants entering the study with IFN-β1 as a background DMT), in the opinion of the Investigator
- Contraindications to MRI, for example, presence of pacemakers or other implanted metal devices (excluding dental braces), an allergy to Gd, renal impairment, or claustrophobia that cannot be medically managed
- History or a positive test result at Screening for human immunodeficiency virus
- Current hepatitis C infection (defined as positive hepatitis C virus [HCV] antibody and detectable HCV Ribonucleic acid (RNA)). Participants with positive HCV antibody and undetectable HCV RNA are eligible to participate in the study (United States [US] Centers for Disease Control and Prevention)
- Current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] or total hepatitis B core antibody [anti-HBc]). Participants with immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive anti-HBc, and positive hepatitis B surface antibody [anti-HBs]) or vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti-HBs) are eligible to participate in the study
- History of systemic hypersensitivity reaction to BIIB061
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- History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 12 weeks of screening
- Clinically significant (as determined by the Investigator) 12-lead ECG or laboratory assessment abnormalities
- Any condition affecting study treatment absorption (e.g., gastrectomy)
- Treatment with statins (3-hydroxy-3-methyl-glutaryl coenzyme A reductase inhibitors) or proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors (e.g., alirocumab and evolocumab) within 8 weeks prior to Day 1/Baseline
- Inability or unwillingness to comply with study requirements
- Other unspecified reasons that, in the opinion of the Investigator or Biogen that make the participant unsuitable for enrollment.
- Note: Other protocol defined inclusion/ exclusion criteria may apply.
About this study
Official title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple Sclerosis
The primary objectives of the study are to evaluate the safety of BIIB061 versus placebo in participants with Relapsing Multiple Sclerosis (RMS), and to evaluate the efficacy of BIIB061 to improve disability outcome versus placebo in participants with RMS.
The secondary objectives of the study are to evaluate the effects of BIIB061 versus placebo on brain magnetic resonance imaging (MRI) markers of remyelination and axon preservation in chronic Multiple Sclerosis lesions and to evaluate the effects of BIIB061 versus placebo on additional measures of improved disability outcome.
Read the detailed description
BIIB061's unique mechanism of action may provide a pharmacological intervention to overcome the failure of remyelination in all forms of multiple sclerosis by blocking mechanisms that prevent differentiation of oligodendrocytes progenitors.
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Placebo, BIIB061, Interferon-beta1, Glatiramer acetate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Administered as specified in the treatment arm.
BIIB061Drug
Administered as specified in the treatment arm.
Interferon-beta1Biological
Also called Avonex, Plegridy, Betaferon/Betaseron, Extavia, or Rebif
Stable dose as prescribed by the physician.
Glatiramer acetateDrug
Also called Copaxone, Glatopa
Stable dose as prescribed by the physician.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive BIIB061-matched placebo, orally once daily in addition to IFN-β1 injection or glatiramer acetate for up to 72 weeks. Receives: Drug: Placebo; Biological: Interferon-beta1; Drug: Glatiramer acetate |
| BIIB061 Dose 1 | Experimental | Participants will receive BIIB061 Dose 1 orally once daily in addition to IFN-β1 injection or glatiramer acetate for up to 72 weeks. Receives: Drug: BIIB061; Biological: Interferon-beta1; Drug: Glatiramer acetate |
| BIIB061 Dose 2 | Experimental | Participants will receive BIIB061 Dose 2 orally once daily in addition to IFN-β1 injection or glatiramer acetate for up to 72 weeks. Receives: Drug: BIIB061; Biological: Interferon-beta1; Drug: Glatiramer acetate |
| BIIB061 Dose 3 | Experimental | Participants will receive BIIB061 Dose 3 orally once daily in addition to IFN-β1 injection or glatiramer acetate for up to 72 weeks. Receives: Drug: BIIB061; Biological: Interferon-beta1; Drug: Glatiramer acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is 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. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: First dose of study drug to end of the study (Up to Week 84)
Overall Disability Response Score (ODRS) at Week 48
ODRS is a multicomponent score based on 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the nondominant hand (9HPT-ND). It assesses overall changes in disability over time. The 4 individual scores are added together to get the overall score that ranges from +4 to -4. At each visit, each component is given a score relative to baseline: -1 if threshold is met for worsening, 0 if no changes meet threshold criteria, or +1 if threshold is met for improvement. The thresholds for T25FW and 9HPT are defined by a 15% change from baseline (≥15% decrease from baseline for improvement and ≥15% increase from baseline for worsening). For EDSS, improvement is defined as a ≥1.0-point decrease in EDSS from a baseline score of ≤6.0, and worsening is defined as a ≥1-point increase from a baseline score of ≤5.5 or a ≥0.5-point increase from a baseline score equal to 6.0.
Measured: Baseline, Week 48
Secondary outcomes (9)
Change from Baseline in Normalized Magnetization Transfer Ratio (nMTR) at Week 48
Remyelination will be measured using magnetization transfer ratio (MTR) in chronic MS lesion detected on brain MRI.
Measured: Baseline, Week 48
Change from Baseline in Diffusion Tensor Imaging Radial Diffusivity (DTI-RD) at Week 48
Axon and myelin preservation will be measured using DTI-RD in chronic MS lesions detected on brain MRI.
Measured: Baseline, Week 48
Change from Baseline in Normalized T1 (nT1) Intensity at Week 48
Remyelination and axon preservation will be assessed by nT1 intensity in chronic MS lesions on brain MRI.
Measured: Baseline, Week 48
Change from Baseline in T1 Hypointense Volume at Week 48
Remyelination and axon preservation will be assessed by T1 hypointense volume in chronic MS lesions on brain MRI.
Measured: Baseline, Week 48
Percentage of Participants with 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND
EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. The T25FW is a quantitative mobility and leg function performance test based on a timed walk over 25 feet. The score for the T25FW is averaged between two completed trials. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs.
Measured: Up to Week 48
Percentage of Participants with 12-week Confirmed Worsening in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND
EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. The T25FW is a quantitative mobility and leg function performance test based on a timed walk over 25 feet. The score for the T25FW is averaged between two completed trials. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs.
Measured: Up to Week 48
ODRS Accounting Only for 12-week Confirmed Events of Worsening and Improvement on Respective Components over the First 48 Weeks of Treatment
ODRS is a multicomponent score based on 4 components: EDSS, T25FW, 9HPT-D, and 9HPT-ND. It assesses overall changes in disability over time. The 4 individual scores are added together to get the overall score that ranges from +4 to -4. At each visit, each component is given a score relative to baseline: -1 if threshold is met for worsening, 0 if no changes meet threshold criteria, or +1 if threshold is met for improvement. The thresholds for T25FW and 9HPT are defined by a 15% change from baseline (≥15% decrease from baseline for improvement and ≥15% increase from baseline for worsening). For EDSS, improvement is defined as a ≥1.0-point decrease in EDSS from a baseline score of ≤6.0, and worsening is defined as a ≥1-point increase from a baseline score of ≤5.5 or a ≥0.5-point increase from a baseline score equal to 6.0.
Measured: 48 weeks
ODRS using 20% Threshold for T25FW over the First 48 Weeks of Treatment
ODRS is a multicomponent score based on 4 components: EDSS, T25FW, 9HPT-D, and 9HPT-ND. It assesses overall changes in disability over time. The 4 individual scores are added together to get the overall score that ranges from +4 to -4. At each visit, each component is given a score relative to baseline: -1 if threshold is met for worsening, 0 if no changes meet threshold criteria, or +1 if threshold is met for improvement. The thresholds for T25FW and 9HPT are a 20% and 15% change from baseline respectively. For EDSS, improvement is defined as a ≥1.0-point decrease in EDSS from a baseline score of ≤6.0, and worsening is defined as a ≥1-point increase from a baseline score of ≤5.5 or a ≥0.5-point increase from a baseline score equal to 6.0.
Measured: 48 weeks
ODRS using 20% Threshold for T25FW, 9HPTD, and 9HPT-ND over the First 48 Weeks of Treatment
ODRS is a multicomponent score based on 4 components: EDSS, T25FW, 9HPT-D, and 9HPT-ND. It assesses overall changes in disability over time. The 4 individual scores are added together to get the overall score that ranges from +4 to -4. At each visit, each component is given a score relative to baseline: -1 if threshold is met for worsening, 0 if no changes meet threshold criteria, or +1 if threshold is met for improvement. The thresholds for T25FW and 9HPT are a 20% change from baseline. For EDSS, improvement is defined as a ≥1.0-point decrease in EDSS from a baseline score of ≤6.0, and worsening is defined as a ≥1-point increase from a baseline score of ≤5.5 or a ≥0.5-point increase from a baseline score equal to 6.0.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start30 Jun 2021 (estimated)
- Primary completion18 Sep 2024 (estimated)
- Study completion18 Sep 2024 (estimated)
Why it stopped: Decision to discontinue BIIB061 program was based on lack of stronger preclinical effects of BIIB061 on remyelination relative to opicinumab, that showed limited clinical efficacy in phase 2 clinical studies. This was not related to safety concerns.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 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
- NCT04079088
- Sponsor's protocol ID
- 231MS201
- Other IDs
- 2019-001847-28, 2019
- Status last verified
- May 2023
- First submitted
- 3 Sep 2019
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04079088
- Acronym / sponsor ID
- 231MS201
- Conditions
- Relapsing Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decision to discontinue BIIB061 program was based on lack of stronger preclinical effects of BIIB061 on remyelination relative to opicinumab, that showed limited clinical efficacy in phase 2 clinical studies. This was not related to safety concerns.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (estimated)
- Primary completion
- 18 Sep 2024 (estimated)
- Study completion
- 18 Sep 2024 (estimated)
- First posted
- 6 Sep 2019 (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.
The primary objectives of the study are to evaluate the safety of BIIB061 versus placebo in participants with Relapsing Multiple Sclerosis (RMS), and to evaluate the efficacy of BIIB061 to improve disability outcome versus placebo in participants with RMS.
The secondary objectives of the study are to evaluate the effects of BIIB061 versus placebo on brain magnetic resonance imaging (MRI) markers of remyelination and axon preservation in chronic Multiple Sclerosis lesions and to evaluate the effects of BIIB061 versus placebo on additional measures of improved disability outcome.
Detailed description
BIIB061's unique mechanism of action may provide a pharmacological intervention to overcome the failure of remyelination in all forms of multiple sclerosis by blocking mechanisms that prevent differentiation of oligodendrocytes progenitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Biological: Interferon-beta1, Drug: Glatiramer acetateParticipants will receive BIIB061-matched placebo, orally once daily in addition to IFN-β1 injection or glatiramer acetate for up to 72 weeks. |
| BIIB061 Dose 1 | Experimental | Drug: BIIB061, Biological: Interferon-beta1, Drug: Glatiramer acetateParticipants will receive BIIB061 Dose 1 orally once daily in addition to IFN-β1 injection or glatiramer acetate for up to 72 weeks. |
| BIIB061 Dose 2 | Experimental | Drug: BIIB061, Biological: Interferon-beta1, Drug: Glatiramer acetateParticipants will receive BIIB061 Dose 2 orally once daily in addition to IFN-β1 injection or glatiramer acetate for up to 72 weeks. |
| BIIB061 Dose 3 | Experimental | Drug: BIIB061, Biological: Interferon-beta1, Drug: Glatiramer acetateParticipants will receive BIIB061 Dose 3 orally once daily in addition to IFN-β1 injection or glatiramer acetate for up to 72 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Diagnosed with relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS)
- Have a Baseline Expanded Disability Status Scale (EDSS) score of 2.0 to 6.0
- Have a MS disease duration of ≤20 years from first MS symptom(s)
- Must have at least one of the following occurring within 12 months prior to
- ≥1 clinical relapse(s) or objective disability worsening (as per treating neurologist's judgment) (b) ≥1 Gadolinium (Gd)-enhancing T1 lesion(s) on brain or spinal cord Magnetic Resonance Imaging (MRI) (c) ≥1 new T2 lesion(s) on brain or spinal cord MRI (the reference scan used to detect new T2 lesion formation has to be ≤12 months prior to Day 1/Baseline)
Key exclusion criteria (13 listed)
- A documented history of clinically significant persistent neutralizing antibody against IFN-β1 (applicable only for participants entering the study with IFN-β1 as a background DMT), in the opinion of the Investigator
- Contraindications to MRI, for example, presence of pacemakers or other implanted metal devices (excluding dental braces), an allergy to Gd, renal impairment, or claustrophobia that cannot be medically managed
- History or a positive test result at Screening for human immunodeficiency virus
- Current hepatitis C infection (defined as positive hepatitis C virus [HCV] antibody and detectable HCV Ribonucleic acid (RNA)). Participants with positive HCV antibody and undetectable HCV RNA are eligible to participate in the study (United States [US] Centers for Disease Control and Prevention)
- Current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] or total hepatitis B core antibody [anti-HBc]). Participants with immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive anti-HBc, and positive hepatitis B surface antibody [anti-HBs]) or vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti-HBs) are eligible to participate in the study
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 |
|---|---|---|
| PlaceboAdministered as specified in the treatment arm. | Drug | Placebo |
| BIIB061Administered as specified in the treatment arm. | Drug | BIIB061 Dose 1, BIIB061 Dose 2, BIIB061 Dose 3 |
| Interferon-beta1Also: Avonex, Plegridy, Betaferon/Betaseron, Extavia, or RebifStable dose as prescribed by the physician. | Biological | BIIB061 Dose 1, BIIB061 Dose 2, BIIB061 Dose 3, Placebo |
| Glatiramer acetateAlso: Copaxone, GlatopaStable dose as prescribed by the physician. | Drug | BIIB061 Dose 1, BIIB061 Dose 2, BIIB061 Dose 3, Placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: First dose of study drug to end of the study (Up to Week 84)
An AE is 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. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Overall Disability Response Score (ODRS) at Week 48
Time frame: Baseline, Week 48
ODRS is a multicomponent score based on 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the nondominant hand (9HPT-ND). It assesses overall changes in disability over time. The 4 individual scores are added together to get the overall score that ranges from +4 to -4. At each visit, each component is given a score relative to baseline: -1 if threshold is met for worsening, 0 if no changes meet threshold criteria, or +1 if threshold is met for improvement. The thresholds for T25FW and 9HPT are defined by a 15% change from baseline (≥15% decrease from baseline for improvement and ≥15% increase from baseline for worsening). For EDSS, improvement is defined as a ≥1.0-point decrease in EDSS from a baseline score of ≤6.0, and worsening is defined as a ≥1-point increase from a baseline score of ≤5.5 or a ≥0.5-point increase from a baseline score equal to 6.0.
9 secondary outcomes
Change from Baseline in Normalized Magnetization Transfer Ratio (nMTR) at Week 48
Time frame: Baseline, Week 48
Change from Baseline in Diffusion Tensor Imaging Radial Diffusivity (DTI-RD) at Week 48
Time frame: Baseline, Week 48
Change from Baseline in Normalized T1 (nT1) Intensity at Week 48
Time frame: Baseline, Week 48
Change from Baseline in T1 Hypointense Volume at Week 48
Time frame: Baseline, Week 48
Percentage of Participants with 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND
Time frame: Up to Week 48
Percentage of Participants with 12-week Confirmed Worsening in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND
Time frame: Up to Week 48
ODRS Accounting Only for 12-week Confirmed Events of Worsening and Improvement on Respective Components over the First 48 Weeks of Treatment
Time frame: 48 weeks
ODRS using 20% Threshold for T25FW over the First 48 Weeks of Treatment
Time frame: 48 weeks
ODRS using 20% Threshold for T25FW, 9HPTD, and 9HPT-ND over the First 48 Weeks of Treatment
Time frame: 48 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 1 Jun 2023.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIIB061, Interferon-beta1 and Glatiramer acetate in people with Relapsing 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 9 inclusion and 13 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 1 Jun 2023. 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 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 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?
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: First dose of study drug to end of the study (Up to Week 84)). The study lists 2 primary outcomes in all. 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 1 Jun 2023.