Relapsing-remitting Multiple SclerosisPhase 2NCT02975349
A Study of Efficacy and Safety of M2951 in Participants With Relapsing Multiple Sclerosis
A Phase 2 study testing Evobrutinib and Tecfidera in people with Relapsing-remitting Multiple Sclerosis, run by EMD Serono Research & Development Institute, Inc. at 56 sites in 8 countries.
Trial summary
The aim of this protocol is to find out about the safety and effectiveness of M2951 in participants with relapsing multiple sclerosis. Participants were placed into 1 of 3 groups to receive M2951, placebo or tecfidera for 24 weeks. After 24 weeks, the participants on placebo were given M2951. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis
- What is being tested?
- Evobrutinib and Tecfidera
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- 56 sitesin 8 countries
- Study dates
- 7 Mar 2017to 2 Apr 2024
- Phase
- Phase 2
- 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
- Participants with a diagnosis of relapsing multiple sclerosis (may include participants with Secondary Progressive Multiple Sclerosis (SPMS) with superimposed relapses provided they meet the other criteria) in accordance with revised McDonald criteria for MS and Lublin and Reingold
- Male or female aged 18 to 65 years
- One or more documented relapses within the 2 years before Screening with either: a) One relapse which occurred within the last year prior to randomization or b) the presence of at least 1 gadolinium-positive (Gd+) T1 lesion within 6 months prior to randomization would make the patient eligible.
- Expanded Disability Status Scale score of 0 to 6 at Baseline
- Women of childbearing potential must use a supplementary barrier method together with a highly effective method of contraception (according to International Council for Harmonisation [ICH] guidance M3[R2]) for 4 weeks prior to randomization, throughout the trial, and for 90 days after the last dose of IMP.
- Signed and dated informed consent (participant must be able to understand the informed consent) indicating that the participant has been informed of all the pertinent aspects of the trial prior to enrolment and will comply with the requirements of the protocol.
Who cannot join
- Progressive MS
- Disease duration > 15 years in participants with EDSS of 2 or less
- Use of the following, as determined in the protocol ; rituximab, ocrelizumab, mitoxantrone, or lymphocyte-depleting therapies, lymphocyte trafficking blockers (eg, natalizumab, fingolimod), intravenous (IV) immunoglobulins (Ig), plasmapheresis, immunosuppressive treatments, B-interferons or glatiramer acetate, Systemic glucocorticoids, teriflunomide
- Exposure to Tecfidera within 6 months prior to randomization
- Any allergy, contraindication, or inability to tolerate Tecfidera
- Treatment with dalfampridine (fampridine, Ampyra) unless on a stable dose for ≥ 30 days prior to randomization
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- Inability to comply with MRI scanning
- Immunologic disorder other than MS, with the exception of secondary well-controlled diabetes or thyroid disorder, or any other condition requiring oral, IV, intramuscular, or intra-articular corticosteroid therapy
- Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening
- Severe drug allergy or history of anaphylaxis, or allergy to the IMP or any of its incipients
- Active, clinically significant viral, bacterial, or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks of Screening, or completion of oral anti-infectives within 2 weeks before or during Screening, or a history of recurrent infections (ie, 3 or more of the same type of infection in a 12-month rolling period). Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled would not be exclusionary.
- History of or positive testing for human immunodeficiency virus (HIV), hepatitis C (HCV) antibody and/or polymerase chain reaction, hepatitis B surface antigen (HBsAg) (+) and/or hepatitis B core total, and/or immunoglobulin M (IgM) antibody (+) at Screening.
- The participant: • Has a history of or current diagnosis of active tuberculosis (TB) or • Is currently undergoing treatment for latent TB infection (LTBI) or • Has an untreated LTBI or • Has a positive QuantiFERON®-TB test at Screening.
- Indeterminate QuantiFERON®
- Participants with current household contacts with active TB will also be excluded
- History of splenectomy or any major surgery within 2 months prior to Screening
- History of myocardial infarction or cerebrovascular event as per the protocol
- History of attempted suicide within 6 months prior to Screening or a positive response to items 4 or 5 of Columbia-Suicide Severity Rating Scale (C-SSRS)
- An episode of major depression within the last 6 months prior to Screening
- On anticoagulation, fish oil supplements, or antiplatelet therapy other than daily aspirin for cardioprotection and treatment of Tecfidera induced flushing
- History of cancer, except adequately treated basal cell or squamous cell carcinoma of the skin
- Breastfeeding/lactating or pregnant women
- Participation in any investigational drug trial within 1 month or 5 half-lives of the investigational drug, whichever is longest, prior to Screening
- Participants currently receiving (or unable to stop using prior to receiving the first dose of IMP) medications or herbal supplements known to be potent inhibitors of cytochrome P450 3A (CYP3A)
- History of or current alcohol or substance abuse
- Clinically significant abnormality on electrocardiogram or screening chest X-ray
- Clinically significant laboratory abnormality
Trial locations and contacts
56 sites in 8 countries.
56 sites in 8 countries
Bulgaria12 sites
Research Site
Blagoevgrad, 2700
Research Site
Dupnitsa, 2600
Research Site 1
Pleven, 5800
Research Site 2
Pleven, 5800
Research Site
Rousse, 7002
Research Site
Sofia, 1142
Research Site
Sofia, 1309
Research Site
Sofia, 1336
Research Site
Sofia, 1407
Research Site
Sofia, 1431
Research Site
Sofia, 1606
Research Site
Sofia, 1797
Ukraine11 sites
Research Site
Chernivtsi, 58018
Research Site
Ivano-Frankivsk, 76008
Research Site
Kharkiv, 61058
Research Site
Kharkiv, 61068
Research Site
Kharkiv, 61103
Research Site
Kyiv, 01601
Research Site
Kyiv, 03110
Research Site
Lviv, 79010
Research Site
Poltava, 36011
Research Site
Zaporizhzhya, 69035
Research Site
Zaporizhzhya, 69600
Poland10 sites
Research Site
Bydgoszcz, 85-654
Research Site
Katowice, 40-595
Research Site
Katowice, 40-650
Research Site
Lodz, 90-324
Research Site
Lublin, 20-605
Research Site
Oświęcim, 32-600
Research Site
Plewiska, 62-064
Research Site
Poznan, 61-853
Research Site
Rzeszów, 35-055
Research Site
Warsaw, 01-697
Russia7 sites
Research Site
Kazan', 420021
Research Site
Krasnoyarsk, 660037
Research Site
Krasnoyarsk, 660049
Research Site
Moscow, 129128
Research Site
Novosibirsk, 630102
Research Site
Perm, 614000
Research Site
Saransk, 430032
Czechia6 sites
Research Site
Brno, 656 91
Research Site
Hradec Králové, 500 05
Research Site
Hradec Králové, 50003
Research Site
Jihlava, 58633
Research Site
Prague, 150 06
Research Site
Teplice, 41529
Serbia4 sites
Research Site
Belgrade, 11000
Research Site
Kragujevac, 34000
Research Site
Niš, 18000
Research Site
Užice, 31000
Slovakia3 sites
Research Site
Banská Bystrica, 97404
Research Site
Bratislava, 85101
Research Site
Dubnica nad Váhom, 01841
Spain3 sites
Research Site
A Coruña, 15006
Research Site
Barcelona, 08003
Research Site
Barcelona, 08035
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 With a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients With Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity.
The aim of this protocol is to find out about the safety and effectiveness of M2951 in participants with relapsing multiple sclerosis. Participants were placed into 1 of 3 groups to receive M2951, placebo or tecfidera for 24 weeks. After 24 weeks, the participants on placebo were given M2951.
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- Evobrutinib, Placebo, Tecfidera
- Keywords
- M2951, Relapsing Multiple Sclerosis, Bruton's Tyrosine Kinase inhibitor
- 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.
EvobrutinibDrug
Also called M2951
Participants received Evobrutinib 75 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 75 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period.
EvobrutinibDrug
Also called M2951
Participants received Evobrutinib 25 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 25 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period.
EvobrutinibDrug
Also called M2951
Participants received Evobrutinib 75 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 75 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period.
PlaceboDrug
Placebo were administered for 24 weeks in active treatment period.
TecfideraDrug
Participants received Tecfidera 120 mg twice daily (BID) for first 7 days followed by 240 mg orally, BID up to Week 48 in active treatment period 1 and BE period received Tecfidera 120 mg BID orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period.
| Study group | Role | What they receive |
|---|---|---|
| Placebo then Evobrutinib 25 mg QD (Period 2) | Experimental | Participants who received placebo matched to Evobrutinib tablet orally for 24 weeks in active treatment period 1 received Evobrutinib 25 milligram (mg) orally, once daily (QD) in blinded extension (BE) period from week 25 to week 48. Receives: Drug: Evobrutinib |
| Evobrutinib 25 mg QD (Period 1, 2 and 3) | Experimental | Participants received Evobrutinib 25 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 25 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. Receives: Drug: Evobrutinib |
| Evobrutinib 75 mg QD (Period 1, 2 and 3) | Experimental | Participants received Evobrutinib 75 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 75 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. Receives: Drug: Evobrutinib |
| Evobrutinib 75 mg BID (Period 1, 2 and 3) | Experimental | Participants received Evobrutinib 75 mg orally, twice daily (BID) up to Week 48 in active treatment period 1 and BE period received Evobrutinib 75 mg BID orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. Receives: Drug: Evobrutinib |
| Tecfidera (Period 1, 2 and 3) | Active comparator | Participants received Tecfidera 120 mg twice daily (BID) for first 7 days followed by 240 mg orally, BID up to Week 48 in active treatment period 1 and BE period received Tecfidera 120 mg BID orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. Receives: Drug: Tecfidera |
| Placebo | Placebo comparator | Participants received placebo matched to Evobrutinib tablet orally for 24 weeks in active treatment period 1. Receives: Drug: Placebo |
| Placebo + Evobrutinib 25 mg QD (Period 3) | Experimental | Participants who received placebo matched to Evobrutinib tablet orally for 24 weeks in active treatment period 1 received Evobrutinib 25 mg orally, QD from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. Receives: Drug: Evobrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Gadolinium-Enhancing T1 Lesions
Analysis of T1-Gadolinium enhancing lesions was done using magnetic resonance imaging (MRI) scans. As per planned analysis, Tecfidera treatment group was not included in inferential analysis.
Measured: Week 12 to Week 24
Secondary outcomes (37)
Annualized Relapse Rate (ARR) at Week 24
A qualifying relapse is defined as new, worsening or recurrent neurological symptoms attributed to Multiple Sclerosis (MS) that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. As per planned analysis, Tecfidera treatment group was not included in inferential analysis.
Measured: Week 24
Qualified Relapse-Free Status at Week 24
A qualifying relapse is defined as new, worsening or recurrent neurological symptoms attributed to Multiple Sclerosis (MS) that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. Percentage of participants with qualified relapse-free status at week 24 were reported. As per planned analysis, Tecfidera treatment group was not included in inferential analysis.
Measured: Week 24
Change From Baseline in Expanded Disability Status Scale (EDSS) at Week 24
The EDSS is an ordinal clinical rating scale in half-point increments. It assesses the following eight functional systems, areas of the central nervous system that control bodily functions: Pyramidal (ability to walk), Cerebellar (coordination), Brain stem (speech and swallowing), Sensory (touch and pain), Bowel and bladder functions, Visual, Mental, Other (includes any other neurological findings due to Multiple Sclerosis [MS]). EDSS overall score ranging from 0 (normal) to 10 (death due to MS). As per planned analysis, Tecfidera treatment group was not included in inferential analysis.
Measured: Baseline, Week 24
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death
An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the date of first dose and within 28 days after the date of last dose in the study. TEAEs include both Serious TEAEs and non-serious TEAEs.
Measured: Baseline up to Safety Follow-up (Week 52)
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs and Electrocardiograms (ECGs)
Vital signs, including semi supine blood pressure, pulse rate, respiratory rate, weight, and oral temperature were assessed. ECG parameters included rhythm, ventricular rate, PR interval, QRS duration, and QT interval. Number of participants with clinically significant change from baseline in vital signs and ECG were reported. Clinical Significance was decided by the investigator.
Measured: Baseline up to Safety Follow-up (Week 52)
Number of Participants With Grade 3 or Higher Hematology, Biochemistry and Urinalysis Values
Hematology, biochemistry, and urinalysis values were graded with National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 toxicity grades (where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening and Grade 5 = death). For the hematology and biochemistry parameters, participants with a value grade 3 or higher were reported. For the urinalysis parameters, participants with a value grade 3 or higher, or a value >= 2 upper limit of normal (ULN), or a value classified as ++ Increasing were reported.
Measured: Baseline up to Safety Follow-up (Week 52)
Absolute Concentrations of Immunoglobulin (Ig) Levels (Active Treatment Period)
Absolute Concentrations serum levels of IgG, IgA, IgM were assessed.
Measured: Baseline (Day 1), Weeks 4, 16, and 24
Absolute Concentrations of Immunoglobulin (Ig) Levels (Blinded Extension Period)
Absolute Concentrations serum levels of IgG, IgA, IgM were assessed.
Measured: Week 48
Change From Baseline in Immunoglobulin (Ig) Levels (Active Treatment Period)
Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
Measured: Baseline (Day 1), Weeks 4, 16, and 24
Change From Baseline in Immunoglobulin (Ig) Levels (Blinded Extension Period)
Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
Measured: Baseline (Week 25), Week 48
Absolute Concentration of B Cells (Active Treatment Period)
Absolute concentration of B Cells are reported.
Measured: Baseline (Day 1), Weeks 4, and 24
Absolute Concentration of B Cells (Blinded Extension Period)
Absolute concentration of B Cells were reported.
Measured: Weeks 48 and 52
Change From Baseline in Absolute B Cells (Active Treatment Period)
Change from baseline in absolute B cells are reported.
Measured: Baseline (Day 1), Weeks 4 and 24
Change From Baseline in Absolute B Cells (Blinded Extension Period)
Change from baseline in absolute B cells are reported.
Measured: Baseline (Week 25), Weeks 48 and 52
Total Number of New Gadolinium-positive (Gd+) T1 Lesions
Analysis of Gadolinium-positive T1 lesions was done using magnetic resonance imaging (MRI) scans. As per planned analysis, Tecfidera treatment group was not included in inferential analysis.
Measured: Week 12 to 24
Mean Per-scan Number of Gadolinium-positive (Gd+) T1 Lesions
Analysis of Gadolinium-positive T1 lesions was done using magnetic resonance imaging (MRI) scans. As per planned analysis, Tecfidera treatment group was not included in inferential analysis.
Measured: Week 12 to Week 24
Total Number of New or Enlarging T2 Lesions
Analysis of New or Enlarging T2 lesions was done using magnetic resonance imaging (MRI) scans. As per planned analysis, Tecfidera treatment group was not included in inferential analysis.
Measured: Week 12 to Week 24
Change From Baseline in Volume of T2 Lesions at Week 24
Analysis of volume of T2 lesions was done using magnetic resonance imaging (MRI) scans. Tecfidera treatment group was not included in inferential analysis.
Measured: Baseline, Week 24
Change From Baseline in Volume of Gadolinium-positive (Gd+) T1 Lesions at Week 24
Analysis of volume of Gd+ T1 lesions was done using magnetic resonance imaging (MRI) scans. As per planned analysis, Tecfidera treatment group was not included in inferential analysis.
Measured: Baseline, Week 24
Number of Gadolinium-positive (Gd+) T1 Lesions at Week 48
Analysis of Gd+ T1 lesions was done using magnetic resonance imaging (MRI) scans.
Measured: Week 48
Number of New Gadolinium-positive (Gd+) T1 Lesions at Week 48
Analysis of new Gd+ T1 lesions was done using magnetic resonance imaging (MRI) scans.
Measured: Week 48
Annualized Relapse Rate (ARR)
A qualifying relapse is defined as new, worsening or recurrent neurological symptoms attributed to Multiple Sclerosis (MS) that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days.
Measured: Week 0 to Week 48
Qualified Relapse-free Status
A qualifying relapse is defined as new, worsening or recurrent neurological symptoms attributed to Multiple Sclerosis (MS) that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. Percentage of participants with qualified relapse-free status were reported.
Measured: Week 25 to Week 48
Change From Week 24 in Expanded Disability Status Scale (EDSS) at Week 48
The EDSS is an ordinal clinical rating scale in half-point increments. It assesses the following eight functional systems, areas of the central nervous system that control bodily functions: Pyramidal (ability to walk), Cerebellar (coordination), Brain stem (speech and swallowing), Sensory (touch and pain), Bowel and bladder functions, Visual, Mental, Other (includes any other neurological findings due to Multiple Sclerosis [MS]). EDSS overall score ranging from 0 (normal) to 10 (death due to MS).
Measured: Week 24, Week 48
Total Number of New or Enlarging T2 Lesions at Week 48 Relative to Week 24
Analysis of New or Enlarging T2 lesions was done using magnetic resonance imaging (MRI) scans.
Measured: Week 24 to Week 48
Change From Week 24 in Volume of Gadolinium-positive (Gd+) T1 Lesions at Week 48
Analysis of volume of Gd+ T1 lesions was done using magnetic resonance imaging (MRI) scans.
Measured: Week 24, Week 48
Change From Week 24 in Volume of T2 Lesions at Week 48
Analysis of volume of T2 lesions was done using magnetic resonance imaging (MRI) scans.
Measured: Week 24, Week 48
OLE Period: Total Number of Gadolinium-Enhancing T1 Lesions
Analysis of T1-Gadolinium enhancing lesions was done using magnetic resonance imaging (MRI) scans.
Measured: OLE Baseline (BE period Week 48), OLE Weeks 96, 144, 192, 240, 288 and 336
OLE Period: Annualized Relapse Rate (ARR)
A qualifying relapse is defined as new, worsening or recurrent neurological symptoms attributed to Multiple Sclerosis (MS) that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days.
Measured: OLE Baseline (BE period Week 48), OLE Weeks 96, 144, 192, 240, 288 and 336
OLE Period: Percentage of Participants With Qualified Relapse-Free Status
A qualifying relapse is defined as new, worsening or recurrent neurological symptoms attributed to Multiple Sclerosis (MS) that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. Percentage of participants with qualified relapse-free status from OLE Baseline (BE period Week 48) up to Week 336 were reported.
Measured: OLE Baseline (BE period Week 48) up to OLE Week 336
OLE Period: Change From Baseline in Expanded Disability Status Scale (EDSS) at Week 96, 144, 192, 240, 288 and 336
The EDSS is an ordinal clinical rating scale in half-point increments. It assesses the following eight functional systems, areas of the central nervous system that control bodily functions: Pyramidal (ability to walk), Cerebellar (coordination), Brain stem (speech and swallowing), Sensory (touch and pain), Bowel and bladder functions, Visual, Mental, Other (includes any other neurological findings due to Multiple Sclerosis [MS]). EDSS overall score ranging from 0 (normal) to 10 (death due to MS).
Measured: OLE Baseline (BE period Week 48), OLE Weeks 96, 144, 192, 240, 288 and 336
OLE Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the date of first dose and within 28 days after the date of last dose in the study. TEAEs include both Serious TEAEs and non-serious TEAEs.
Measured: OLE Baseline (BE period Week 48) up to OLE Week 336
OLE Period: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
Vital signs, including semi supine blood pressure, pulse rate, respiratory rate, weight, and oral temperature were assessed. Number of participants with clinically significant change from baseline in vital signs were reported. Clinical Significance was decided by the investigator.
Measured: OLE Baseline (BE period Week 48) up to OLE Week 336
OLE Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
Laboratory parameters included hematology, biochemistry, and urinalysis. Number of participants with clinically significant change from baseline in laboratory parameters were reported. Clinical Significance was decided by the investigator.
Measured: OLE Baseline (BE period Week 48) up to OLE Week 336
OLE Period: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)
ECG parameters included rhythm, ventricular rate, PR interval, QRS duration, and QT interval. Number of participants with clinically significant change from baseline in ECG were reported. Clinical Significance was decided by the investigator.
Measured: OLE Baseline (BE period Week 48) up to OLE Week 336
OLE Period: Absolute Concentrations of Immunoglobulin (Ig) Levels
Absolute Concentrations serum levels of IgG, IgA, IgM were assessed.
Measured: OLE Baseline (BE period Week 48), OLE Weeks 96, 144, 192, 240 and 288
OLE Period: Change From Baseline in Immunoglobulin (Ig) Levels
Change from baseline in the serum levels of IgG, IgA, IgM were assessed.
Measured: OLE Baseline (BE period Week 48), OLE Weeks 96, 144, 192, 240 and 288
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start7 Mar 2017
- Primary completion24 Jan 2018
- Study completion2 Apr 2024
Why it stopped: Results from the EVOLUTION clinical trials showed evobrutinib did not meet its primary endpoint of annualized relapse rate for up to 156 weeks compared to oral teriflunomide in both studies.
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.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Relapsing-remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The 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
- Investigator, Outcomes assessor
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975349
- Sponsor's protocol ID
- MS200527-0086
- Other IDs
- 2016-001448-21, 2016
- Status last verified
- May 2025
- First submitted
- 23 Nov 2016
- Last updated
- 14 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per company policy and with respect to the principles set forth by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Pharmaceutical Research and Manufacturers of America (PhRMA), the Declaration of Helsinki, and applicable laws and regulations , we inform the public about the designs and results of our clinical trials in a timely and balanced manner, regardless of the outcome. We are committed to enhancing public health through responsible sharing of clinical trial data in a manner that is consistent with: safeguarding the privacy of patients; respecting the integrity of national regulatory systems; and maintaining incentives for investment in biomedical research.
Publications
Montalban X, Arnold DL, Weber MS, Staikov I, Piasecka-Stryczynska K, Willmer J, Martin EC, Dangond F, Syed S, Wolinsky JS; Evobrutinib Phase 2 Study Group. Placebo-Controlled Trial of an Oral BTK Inhibitor in Multiple Sclerosis. N Engl J Med. 2019 Jun 20;380(25):2406-2417. doi: 10.1056/NEJMoa1901981. Epub 2019 May 10.
PubMed 31075187Arnold DL, Elliott C, Martin EC, Hyvert Y, Tomic D, Montalban X. Effect of Evobrutinib on Slowly Expanding Lesion Volume in Relapsing Multiple Sclerosis: A Post Hoc Analysis of a Phase 2 Trial. Neurology. 2024 Mar 12;102(5):e208058. doi: 10.1212/WNL.0000000000208058. Epub 2024 Feb 9.
PubMed 38335474Papasouliotis O, Mitchell D, Girard P, Dangond F, Dyroff M. Determination of a clinically effective evobrutinib dose: Exposure-response analyses of a phase II relapsing multiple sclerosis study. Clin Transl Sci. 2022 Dec;15(12):2888-2898. doi: 10.1111/cts.13407. Epub 2022 Sep 30.
PubMed 36126241Montalban X, Wallace D, Genovese MC, Tomic D, Parsons-Rich D, Le Bolay C, Kao AH, Guehring H. Characterisation of the safety profile of evobrutinib in over 1000 patients from phase II clinical trials in multiple sclerosis, rheumatoid arthritis and systemic lupus erythematosus: an integrated safety analysis. J Neurol Neurosurg Psychiatry. 2023 Jan;94(1):1-9. doi: 10.1136/jnnp-2022-328799. Epub 2022 Nov 23.
PubMed 36418156Bar-Or A, Cross AH, Cunningham AL, Hyvert Y, Seitzinger A, Guhring H, Drouin EE, Alexandri N, Tomic D, Montalban X. Antibody response to SARS-CoV-2 vaccines in patients with relapsing multiple sclerosis treated with evobrutinib: A Bruton's tyrosine kinase inhibitor. Mult Scler. 2023 Oct;29(11-12):1471-1481. doi: 10.1177/13524585231192460. Epub 2023 Aug 25.
PubMed 37626477Montalban X, Wallace D, Genovese MC, Tomic D, Parsons-Rich D, Bolay CL, Kao AH, Guehring H. A plain language summary of what clinical studies can tell us about the safety of evobrutinib - a potential treatment for multiple sclerosis. Neurodegener Dis Manag. 2023 Aug;13(4):207-213. doi: 10.2217/nmt-2023-0003. Epub 2023 Jun 22.
PubMed 37345645
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 With a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients With Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity.
- ClinicalTrials.gov ID
- NCT02975349
- Acronym / sponsor ID
- MS200527-0086
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Keywords
- M2951, Relapsing Multiple Sclerosis, Bruton's Tyrosine Kinase inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results from the EVOLUTION clinical trials showed evobrutinib did not meet its primary endpoint of annualized relapse rate for up to 156 weeks compared to oral teriflunomide in both studies.
- Enrolment
- 267 participants (actual)
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Posted 5 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this protocol is to find out about the safety and effectiveness of M2951 in participants with relapsing multiple sclerosis. Participants were placed into 1 of 3 groups to receive M2951, placebo or tecfidera for 24 weeks. After 24 weeks, the participants on placebo were given M2951.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo then Evobrutinib 25 mg QD (Period 2) | Experimental | Drug: EvobrutinibParticipants who received placebo matched to Evobrutinib tablet orally for 24 weeks in active treatment period 1 received Evobrutinib 25 milligram (mg) orally, once daily (QD) in blinded extension (BE) period from week 25 to week 48. |
| Evobrutinib 25 mg QD (Period 1, 2 and 3) | Experimental | Drug: EvobrutinibParticipants received Evobrutinib 25 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 25 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. |
| Evobrutinib 75 mg QD (Period 1, 2 and 3) | Experimental | Drug: EvobrutinibParticipants received Evobrutinib 75 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 75 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. |
| Evobrutinib 75 mg BID (Period 1, 2 and 3) | Experimental | Drug: EvobrutinibParticipants received Evobrutinib 75 mg orally, twice daily (BID) up to Week 48 in active treatment period 1 and BE period received Evobrutinib 75 mg BID orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. |
| Tecfidera (Period 1, 2 and 3) | Active comparator | Drug: TecfideraParticipants received Tecfidera 120 mg twice daily (BID) for first 7 days followed by 240 mg orally, BID up to Week 48 in active treatment period 1 and BE period received Tecfidera 120 mg BID orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo matched to Evobrutinib tablet orally for 24 weeks in active treatment period 1. |
| Placebo + Evobrutinib 25 mg QD (Period 3) | Experimental | Drug: EvobrutinibParticipants who received placebo matched to Evobrutinib tablet orally for 24 weeks in active treatment period 1 received Evobrutinib 25 mg orally, QD from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants with a diagnosis of relapsing multiple sclerosis (may include participants with Secondary Progressive Multiple Sclerosis (SPMS) with superimposed relapses provided they meet the other criteria) in accordance with revised McDonald criteria for MS and Lublin and Reingold
- Male or female aged 18 to 65 years
- One or more documented relapses within the 2 years before Screening with either: a) One relapse which occurred within the last year prior to randomization or b) the presence of at least 1 gadolinium-positive (Gd+) T1 lesion within 6 months prior to randomization would make the patient eligible.
- Expanded Disability Status Scale score of 0 to 6 at Baseline
- Women of childbearing potential must use a supplementary barrier method together with a highly effective method of contraception (according to International Council for Harmonisation [ICH] guidance M3[R2]) for 4 weeks prior to randomization, throughout the trial, and for 90 days after the last dose of IMP.
Key exclusion criteria (27 listed)
- Progressive MS
- Disease duration > 15 years in participants with EDSS of 2 or less
- Use of the following, as determined in the protocol ; rituximab, ocrelizumab, mitoxantrone, or lymphocyte-depleting therapies, lymphocyte trafficking blockers (eg, natalizumab, fingolimod), intravenous (IV) immunoglobulins (Ig), plasmapheresis, immunosuppressive treatments, B-interferons or glatiramer acetate, Systemic glucocorticoids, teriflunomide
- Exposure to Tecfidera within 6 months prior to randomization
- Any allergy, contraindication, or inability to tolerate Tecfidera
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 |
|---|---|---|
| EvobrutinibAlso: M2951Participants received Evobrutinib 75 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 75 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. | Drug | Evobrutinib 75 mg BID (Period 1, 2 and 3) |
| EvobrutinibAlso: M2951Participants received Evobrutinib 25 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 25 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. | Drug | Evobrutinib 25 mg QD (Period 1, 2 and 3), Placebo + Evobrutinib 25 mg QD (Period 3), Placebo then Evobrutinib 25 mg QD (Period 2) |
| EvobrutinibAlso: M2951Participants received Evobrutinib 75 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 75 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. | Drug | Evobrutinib 75 mg QD (Period 1, 2 and 3) |
| PlaceboPlacebo were administered for 24 weeks in active treatment period. | Drug | Placebo |
| TecfideraParticipants received Tecfidera 120 mg twice daily (BID) for first 7 days followed by 240 mg orally, BID up to Week 48 in active treatment period 1 and BE period received Tecfidera 120 mg BID orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period. | Drug | Tecfidera (Period 1, 2 and 3) |
Primary outcome
Total Number of Gadolinium-Enhancing T1 Lesions
Time frame: Week 12 to Week 24
Analysis of T1-Gadolinium enhancing lesions was done using magnetic resonance imaging (MRI) scans. As per planned analysis, Tecfidera treatment group was not included in inferential analysis.
37 secondary outcomes
Annualized Relapse Rate (ARR) at Week 24
Time frame: Week 24
Qualified Relapse-Free Status at Week 24
Time frame: Week 24
Change From Baseline in Expanded Disability Status Scale (EDSS) at Week 24
Time frame: Baseline, Week 24
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death
Time frame: Baseline up to Safety Follow-up (Week 52)
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs and Electrocardiograms (ECGs)
Time frame: Baseline up to Safety Follow-up (Week 52)
Number of Participants With Grade 3 or Higher Hematology, Biochemistry and Urinalysis Values
Time frame: Baseline up to Safety Follow-up (Week 52)
Absolute Concentrations of Immunoglobulin (Ig) Levels (Active Treatment Period)
Time frame: Baseline (Day 1), Weeks 4, 16, and 24
Absolute Concentrations of Immunoglobulin (Ig) Levels (Blinded Extension Period)
Time frame: Week 48
Change From Baseline in Immunoglobulin (Ig) Levels (Active Treatment Period)
Time frame: Baseline (Day 1), Weeks 4, 16, and 24
Change From Baseline in Immunoglobulin (Ig) Levels (Blinded Extension Period)
Time frame: Baseline (Week 25), Week 48
Absolute Concentration of B Cells (Active Treatment Period)
Time frame: Baseline (Day 1), Weeks 4, and 24
Absolute Concentration of B Cells (Blinded Extension Period)
Time frame: Weeks 48 and 52
Change From Baseline in Absolute B Cells (Active Treatment Period)
Time frame: Baseline (Day 1), Weeks 4 and 24
Change From Baseline in Absolute B Cells (Blinded Extension Period)
Time frame: Baseline (Week 25), Weeks 48 and 52
Total Number of New Gadolinium-positive (Gd+) T1 Lesions
Time frame: Week 12 to 24
Mean Per-scan Number of Gadolinium-positive (Gd+) T1 Lesions
Time frame: Week 12 to Week 24
Total Number of New or Enlarging T2 Lesions
Time frame: Week 12 to Week 24
Change From Baseline in Volume of T2 Lesions at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Volume of Gadolinium-positive (Gd+) T1 Lesions at Week 24
Time frame: Baseline, Week 24
Number of Gadolinium-positive (Gd+) T1 Lesions at Week 48
Time frame: Week 48
Number of New Gadolinium-positive (Gd+) T1 Lesions at Week 48
Time frame: Week 48
Annualized Relapse Rate (ARR)
Time frame: Week 0 to Week 48
Qualified Relapse-free Status
Time frame: Week 25 to Week 48
Change From Week 24 in Expanded Disability Status Scale (EDSS) at Week 48
Time frame: Week 24, Week 48
Total Number of New or Enlarging T2 Lesions at Week 48 Relative to Week 24
Time frame: Week 24 to Week 48
Change From Week 24 in Volume of Gadolinium-positive (Gd+) T1 Lesions at Week 48
Time frame: Week 24, Week 48
Change From Week 24 in Volume of T2 Lesions at Week 48
Time frame: Week 24, Week 48
OLE Period: Total Number of Gadolinium-Enhancing T1 Lesions
Time frame: OLE Baseline (BE period Week 48), OLE Weeks 96, 144, 192, 240, 288 and 336
OLE Period: Annualized Relapse Rate (ARR)
Time frame: OLE Baseline (BE period Week 48), OLE Weeks 96, 144, 192, 240, 288 and 336
OLE Period: Percentage of Participants With Qualified Relapse-Free Status
Time frame: OLE Baseline (BE period Week 48) up to OLE Week 336
OLE Period: Change From Baseline in Expanded Disability Status Scale (EDSS) at Week 96, 144, 192, 240, 288 and 336
Time frame: OLE Baseline (BE period Week 48), OLE Weeks 96, 144, 192, 240, 288 and 336
OLE Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: OLE Baseline (BE period Week 48) up to OLE Week 336
OLE Period: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
Time frame: OLE Baseline (BE period Week 48) up to OLE Week 336
OLE Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
Time frame: OLE Baseline (BE period Week 48) up to OLE Week 336
OLE Period: Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECGs)
Time frame: OLE Baseline (BE period Week 48) up to OLE Week 336
OLE Period: Absolute Concentrations of Immunoglobulin (Ig) Levels
Time frame: OLE Baseline (BE period Week 48), OLE Weeks 96, 144, 192, 240 and 288
OLE Period: Change From Baseline in Immunoglobulin (Ig) Levels
Time frame: OLE Baseline (BE period Week 48), OLE Weeks 96, 144, 192, 240 and 288
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31075187Montalban X, Arnold DL, Weber MS, Staikov I, Piasecka-Stryczynska K, Willmer J, Martin EC, Dangond F, Syed S, Wolinsky JS; Evobrutinib Phase 2 Study Group. Placebo-Controlled Trial of an Oral BTK Inhibitor in Multiple Sclerosis. N Engl J Med. 2019 Jun 20;380(25):2406-2417. doi: 10.1056/NEJMoa1901981. Epub 2019 May 10.
- Results publication: PubMed 38335474Arnold DL, Elliott C, Martin EC, Hyvert Y, Tomic D, Montalban X. Effect of Evobrutinib on Slowly Expanding Lesion Volume in Relapsing Multiple Sclerosis: A Post Hoc Analysis of a Phase 2 Trial. Neurology. 2024 Mar 12;102(5):e208058. doi: 10.1212/WNL.0000000000208058. Epub 2024 Feb 9.
- Results publication: PubMed 36126241Papasouliotis O, Mitchell D, Girard P, Dangond F, Dyroff M. Determination of a clinically effective evobrutinib dose: Exposure-response analyses of a phase II relapsing multiple sclerosis study. Clin Transl Sci. 2022 Dec;15(12):2888-2898. doi: 10.1111/cts.13407. Epub 2022 Sep 30.
- Results publication: PubMed 36418156Montalban X, Wallace D, Genovese MC, Tomic D, Parsons-Rich D, Le Bolay C, Kao AH, Guehring H. Characterisation of the safety profile of evobrutinib in over 1000 patients from phase II clinical trials in multiple sclerosis, rheumatoid arthritis and systemic lupus erythematosus: an integrated safety analysis. J Neurol Neurosurg Psychiatry. 2023 Jan;94(1):1-9. doi: 10.1136/jnnp-2022-328799. Epub 2022 Nov 23.
- Results publication: PubMed 37626477Bar-Or A, Cross AH, Cunningham AL, Hyvert Y, Seitzinger A, Guhring H, Drouin EE, Alexandri N, Tomic D, Montalban X. Antibody response to SARS-CoV-2 vaccines in patients with relapsing multiple sclerosis treated with evobrutinib: A Bruton's tyrosine kinase inhibitor. Mult Scler. 2023 Oct;29(11-12):1471-1481. doi: 10.1177/13524585231192460. Epub 2023 Aug 25.
- Derived from this study: PubMed 37345645Montalban X, Wallace D, Genovese MC, Tomic D, Parsons-Rich D, Bolay CL, Kao AH, Guehring H. A plain language summary of what clinical studies can tell us about the safety of evobrutinib - a potential treatment for multiple sclerosis. Neurodegener Dis Manag. 2023 Aug;13(4):207-213. doi: 10.2217/nmt-2023-0003. Epub 2023 Jun 22.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Per company policy and with respect to the principles set forth by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Pharmaceutical Research and Manufacturers of America (PhRMA), the Declaration of Helsinki, and applicable laws and regulations , we inform the public about the designs and results of our clinical trials in a timely and balanced manner, regardless of the outcome. We are committed to enhancing public health through responsible sharing of clinical trial data in a manner that is consistent with: safeguarding the privacy of patients; respecting the integrity of national regulatory systems; and maintaining incentives for investment in biomedical research.
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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. This study is not recruiting at the moment.
Medical Responsible study director
EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
56 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Evobrutinib and Tecfidera in people with Relapsing-remitting Multiple Sclerosis, run by EMD Serono Research & Development Institute, Inc. at 56 sites in 8 countries.
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 6 inclusion and 27 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 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in Bulgaria, Ukraine, Poland, Russia, Czechia and 3 more countries. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2021). 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?
Total Number of Gadolinium-Enhancing T1 Lesions (time frame: Week 12 to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02975349, which also lists 6 linked publications.
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 14 May 2025.