A Phase 3 interventional study of Evobrutinib and Avonex® in Relapsing-remitting Multiple Sclerosis, sponsored by EMD Serono Research & Development Institute, Inc.. Terminated at 2 sites in 2 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-08-05.
Sponsored by EMD Serono Research & Development Institute, Inc. · Phase 3, Interventional, and Treatment
The study was to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Interferon-beta-1a (Avonex®), once a week intramuscularly in participants with RMS.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 3 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →EMD Serono Research & Development Institute, Inc. is the lead sponsor of 85 studies on the registry; 8 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 38 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: - Participants are diagnosed with RMS (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS] with relapses) in accordance with 2017 Revised McDonald criteria (Thompson 2018) - Participants with 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-enhancing (Gd+) T1 lesion within 6 months prior to randomization - Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Baseline. Participants with an EDSS score \<= 2 at Screening are only eligible for participation if their disease duration (time since onset of symptoms) is no more than 10 years - Participants are neurologically stable for >= 30 days prior to both screening and baseline - Female participants must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either: post-menopausal or surgically sterile or use an effective method of contraception for the duration of the study - Participants have given written informed consent prior to any study-related procedure - Other protocol defined inclusion criteria could apply Exclusion Criteria: - Participants diagnosed with Progressive MS, in accordance with the 2017 Revised McDonald criteria as follows: a). Participants with Primary Progressive MS. b). Participants with secondary progressive MS without evidence of relapse.
Participants received active evobrutinib twice daily (BID) along with concomitant intramuscular (IM) injection of placebo matched to Avonex® once a week. Treatment period was planned to be of 96 weeks.
Drug: Evobrutinib · Drug: Avonex® matched Placebo
Participants received IM injection of active Avonex® once a week along with concomitant placebo matched to evobrutinib BID. Treatment period was planned to be of 96 weeks.
Drug: Avonex® · Drug: Evobrutinib matched Placebo
Participants received evobrutinib twice daily (BID).
Also known as: M2951
Participants received avonex® IM injection once a week.
Participants received IM injection of placebo matched to Avonex® once a week.
Participants received placebo matched to evobrutinib twice a day.
Annualized Relapse Rate (ARR)
The annualized relapse rate at 96 weeks was to be calculated based on qualified relapses. A qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to MS. The relapse should be accompanied by an increase of 0.5 points or more on Expanded Disability Status Scale (EDSS), or 2 points increase on one of the Functional System Scores (FSS), or 1 point increase on at least two of the FSS. The increase in FSS scores must be related to the neurological symptoms which were reported as new or worsening.
Time frame: At Week 96
Time to First Occurrence of 12-Week Confirmed Expanded Disability Status Scale (EDSS) Progression
EDSS is an ordinal scale in half-point increments that measures disability in participants with MS. EDSS progression is defined as an increase of 1 point or more from Baseline EDSS score when the Baseline score is 5.0 or less, and an increase of 0.5 points or more when the Baseline score is 5.5 or greater. Time to first occurrence of 12-week confirmed EDSS progression is defined as the time from randomization to the first EDSS progression event that was confirmed at a regularly scheduled visit at least 12 weeks later.
Time frame: Baseline up to 96 weeks
Time to First Occurrence of 24-Week Confirmed Expanded Disability Status Scale (EDSS) Progression
EDSS is an ordinal scale in half-point increments that measures disability in participants with MS. EDSS progression is defined as an increase of 1 point or more from Baseline EDSS score when the Baseline score is 5.0 or less, and an increase of 0.5 points or more when the Baseline score is 5.5 or greater. Time to first occurrence of 24-week confirmed EDSS progression is defined as the time from randomization to the first EDSS progression event that was confirmed at a regularly scheduled visit at least 24 weeks later.
Time frame: Baseline up to 96 weeks
Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Short Form Score at Week 96
The PROMIS PF Short Form is specific to measuring the physical function domain of MS patients, with each item on the form scored on a T-score metric. Higher scores indicate higher PF. Change from baseline at Week 96 is the difference between the PROMIS PF scores at 96 weeks and at baseline.
Time frame: Baseline, Week 96
Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Fatigue Score at Week 96
The PROMIS Fatigue Short Form is specific to measuring the fatigue domain of MS patients, with each item on the form scored on a T-score metric. Higher scores indicate higher fatigue. Change from baseline at Week 96 is the difference between the PROMIS Fatigue scores at 96 weeks and at baseline.
Time frame: Baseline, Week 96
Total Number of Gadolinium-Enhancing (Gd+) Time Constant 1 (T1) Lesions Assessed by Magnetic Resonance Imaging (MRI) Scans at Week 24, 48, and 96
Total number of Gd+ T1 lesions was to be assessed using magnetic resonance imaging (MRI).
Time frame: At Week 24, 48 and 96
Total Number of New or Enlarging Time Constant 2 (T2) Lesions Assessed by Magnetic Resonance Imaging (MRI) Scans at Week 24, 48, and 96
Total number of new or enlarging T2 lesions was to be assessed using magnetic resonance imaging (MRI).
Time frame: At Week 24, 48 and 96
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, regardless if it is considered related to the medicinal product. TEAE is an AE that started after study drug treatment; or if the event was continuous from baseline and was serious, related to study drug, or resulted in death, discontinuation, interruption or reduction of study therapy. TEAEs includes both serious TEAEs and non-serious TEAEs. AESIs included liver AEs (possible drug induced, non-infectious, non-alcoholic and immune-mediated) infections (serious and opportunistic infections), lipase and amylase elevation, and seizure.
Time frame: Baseline up to 235 days
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)
TEAE is an AE that started after study drug treatment; or if the event was continuous from baseline and was serious, related to investigational medicinal product (IMP), or resulted in death, discontinuation, interruption or reduction of study therapy. Severity of TEAEs were graded using NCI-CTCAE v4.03 toxicity grades, as follows: Grade 1= Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death. Number of participants with TEAEs based on severity were reported.
Time frame: Baseline up to 235 days
Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP and SBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
Time frame: At Day 1, 83, 125 and 155
Vital Signs: Pulse Rate
Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
Time frame: At Day 1, 83, 125 and 155
Vital Signs: Respiratory Rate
Respiration rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
Time frame: At Day 1, 83, 125 and 155
Vital Signs: Temperature
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
Time frame: At Day 1, 83, 125 and 155
Vital Signs: Weight
Time frame: At Day 1, 83, 125 and 155
Number of Participants With Abnormal Lab Values
The total number of participants with laboratory test abnormalities was assessed. Clinical laboratory tests included hematology, coagulation, biochemistry and urinalysis.
Time frame: Baseline up to 235 days
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
ECG parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals.
Time frame: Baseline up to 235 days
Absolute Concentrations of Immunoglobulin (Ig) A Level
Absolute concentrations of Immunoglobulin (Ig) A was reported.
Time frame: At Day 1, 83, 125 and 155
Absolute Concentrations of Immunoglobulin (Ig) E Level
Absolute concentrations of Immunoglobulin (Ig) E was reported.
Time frame: At Day 1, 83, 125 and 155
Absolute Concentrations of Immunoglobulin (Ig) G Level
Absolute concentrations of Immunoglobulin (Ig) G was reported.
Time frame: At Day 1, 83, 125 and 155
Absolute Concentrations of Immunoglobulin (Ig) M Level
Absolute concentrations of Immunoglobulin (Ig) M was reported.
Time frame: At Day 1, 83, 125 and 155
Change From Baseline in Immunoglobulin (Ig) A Level
Change from baseline in immunoglobulin (Ig) A level was reported.
Time frame: At Day 1, 83, 125 and 155
Change From Baseline in Immunoglobulin (Ig) E Level
Change from baseline in immunoglobulin (Ig) E level was reported.
Time frame: At Day 1, 83, 125 and 155
Change From Baseline in Immunoglobulin (Ig) G Level
Change from baseline in immunoglobulin (Ig) G level was reported.
Time frame: At Day 1, 83, 125 and 155
Change From Baseline in Immunoglobulin (Ig) M Level
Change from baseline in immunoglobulin (Ig) M level was reported.
Time frame: At Day 1, 83, 125 and 155
| Milestone | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Started | 2 | 1 |
| Completed | 0 | 0 |
| Not completed | 2 | 1 |
| Withdrew: Study termination | 2 | 1 |
The annualized relapse rate at 96 weeks was to be calculated based on qualified relapses. A qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to MS. The relapse should be accompanied by an increase of 0.5 points or more on Expanded Disability Status Scale (EDSS), or 2 points increase on one of the Functional System Scores (FSS), or 1 point increase on at least two of the FSS. The increase in FSS scores must be related to the neurological symptoms which were reported as new or worsening.
No measurements were reported for this outcome.
EDSS is an ordinal scale in half-point increments that measures disability in participants with MS. EDSS progression is defined as an increase of 1 point or more from Baseline EDSS score when the Baseline score is 5.0 or less, and an increase of 0.5 points or more when the Baseline score is 5.5 or greater. Time to first occurrence of 12-week confirmed EDSS progression is defined as the time from randomization to the first EDSS progression event that was confirmed at a regularly scheduled visit at least 12 weeks later.
No measurements were reported for this outcome.
EDSS is an ordinal scale in half-point increments that measures disability in participants with MS. EDSS progression is defined as an increase of 1 point or more from Baseline EDSS score when the Baseline score is 5.0 or less, and an increase of 0.5 points or more when the Baseline score is 5.5 or greater. Time to first occurrence of 24-week confirmed EDSS progression is defined as the time from randomization to the first EDSS progression event that was confirmed at a regularly scheduled visit at least 24 weeks later.
No measurements were reported for this outcome.
The PROMIS PF Short Form is specific to measuring the physical function domain of MS patients, with each item on the form scored on a T-score metric. Higher scores indicate higher PF. Change from baseline at Week 96 is the difference between the PROMIS PF scores at 96 weeks and at baseline.
No measurements were reported for this outcome.
The PROMIS Fatigue Short Form is specific to measuring the fatigue domain of MS patients, with each item on the form scored on a T-score metric. Higher scores indicate higher fatigue. Change from baseline at Week 96 is the difference between the PROMIS Fatigue scores at 96 weeks and at baseline.
No measurements were reported for this outcome.
Total number of Gd+ T1 lesions was to be assessed using magnetic resonance imaging (MRI).
No measurements were reported for this outcome.
Total number of new or enlarging T2 lesions was to be assessed using magnetic resonance imaging (MRI).
No measurements were reported for this outcome.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, regardless if it is considered related to the medicinal product. TEAE is an AE that started after study drug treatment; or if the event was continuous from baseline and was serious, related to study drug, or resulted in death, discontinuation, interruption or reduction of study therapy. TEAEs includes both serious TEAEs and non-serious TEAEs. AESIs included liver AEs (possible drug induced, non-infectious, non-alcoholic and immune-mediated) infections (serious and opportunistic infections), lipase and amylase elevation, and seizure.
| Participants | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Participants with AESIs | 0 | 0 |
| Participants with TEAEs | 2 | 1 |
| Participants with Serious TEAEs | 0 | 0 |
TEAE is an AE that started after study drug treatment; or if the event was continuous from baseline and was serious, related to investigational medicinal product (IMP), or resulted in death, discontinuation, interruption or reduction of study therapy. Severity of TEAEs were graded using NCI-CTCAE v4.03 toxicity grades, as follows: Grade 1= Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death. Number of participants with TEAEs based on severity were reported.
| Participants | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Grade 1 | 2 | 0 |
| Grade 2 | 0 | 1 |
| Grade 3 | 0 | 0 |
| Grade 4 | 0 | 0 |
| Grade 5 | 0 | 0 |
DBP and SBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
| Millimeters of mercury (mmHg) | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Participants 1 - DBP: Day 1 | — | 82 |
| Participants 1 - DBP: Day 83 | — | 87 |
| Participants 1 - DBP: Day 125 | — | 80 |
| Participants 1 - DBP: Day 155 | — | 75 |
| Participants 1 - SBP: Day 1 | — | 112 |
| Participants 1 - SBP: Day 83 | — | 120 |
| Participants 1 - SBP: Day 125 | — | 118 |
| Participants 1 - SBP: Day 155 | — | 109 |
| Participants 2 - DBP: Day 1 | 84 | — |
| Participants 2 - DBP: Day 83 | 77 | — |
| Participants 2 - DBP: Day 125 | 84 | — |
| Participants 2 - DBP: Day 155 | 90 | — |
| Participants 2 - SBP: Day 1 | 124 | — |
| Participants 2 - SBP: Day 83 | 133 | — |
| Participants 2 - SBP: Day 125 | 138 | — |
| Participants 2 - SBP: Day 155 | 137 | — |
| Participant 3 - DBP: Day 1 | 65 | — |
| Participants 3 - DBP: Day 125 | 76 | — |
| Participants 3 - SBP: Day 1 | 101 | — |
| Participant 3 - SBP: Day 125 | 117 | — |
Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
| Beats per minute | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Participants 1 - Pulse rate: Day 1 | — | 71 |
| Participants 1 - Pulse rate: Day 83 | — | 69 |
| Participants 1 - Pulse rate: Day 125 | — | 72 |
| Participants 1 - Pulse rate: Day 155 | — | 75 |
| Participants 2 - Pulse rate: Day 1 | 71 | — |
| Participants 2 - Pulse rate: Day 83 | 66 | — |
| Participants 2 - Pulse rate: Day 125 | 82 | — |
| Participants 2 - Pulse rate: Day 155 | 82 | — |
| Participant 3 - Pulse rate: Day 1 | 76 | — |
| Participants 3 - Pulse rate: Day 125 | 75 | — |
Respiration rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
| Breaths Per Minute | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Participants 1 - Respiratory rate: Day 1 | — | 20 |
| Participants 1 - Respiratory rate: Day 83 | — | 18 |
| Participants 1 - Respiratory rate: Day 125 | — | 18 |
| Participants 1 - Respiratory rate: Day 155 | — | 20 |
| Participants 2 - Respiratory rate: Day 1 | 18 | — |
| Participants 2 - Respiratory rate: Day 83 | 20 | — |
| Participants 2 - Respiratory rate: Day 125 | 18 | — |
| Participants 2 - Respiratory rate: Day 155 | 20 | — |
| Participant 3 - Respiratory rate: Day 1 | 18 | — |
| Participants 3 - Respiratory rate: Day 125 | 18 | — |
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points.
| Degree celsius | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Participants 1: Day 1 | — | 35.7 |
| Participants 1: Day 83 | — | 36.4 |
| Participants 1: Day 125 | — | 36.9 |
| Participants 1: Day 155 | — | 36.4 |
| Participants 2: Day 1 | 36.9 | — |
| Participants 2: Day 83 | 36.7 | — |
| Participants 2: Day 125 | 36.9 | — |
| Participants 2: Day 155 | 36.8 | — |
| Participant 3: Day 1 | 36.5 | — |
| Participants 3: Day 125 | 37.0 | — |
| kilogram (kg) | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Participants 1: Day 1 | — | 75.7 |
| Participants 1: Day 83 | — | 74.9 |
| Participants 1: Day 125 | — | 77.3 |
| Participants 1: Day 155 | — | 77.2 |
| Participants 2: Day 1 | 89.0 | — |
| Participants 2: Day 83 | 89.0 | — |
| Participants 2: Day 125 | 92.2 | — |
| Participants 2: Day 155 | 92.1 | — |
| Participant 3: Day 1 | 40.8 | — |
| Participants 3: Day 125 | 40.3 | — |
The total number of participants with laboratory test abnormalities was assessed. Clinical laboratory tests included hematology, coagulation, biochemistry and urinalysis.
| Participants | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Number of Participants With Abnormal Lab Values | 0 | 0 |
ECG parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals.
| Participants | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | 0 | 0 |
Absolute concentrations of Immunoglobulin (Ig) A was reported.
| grams per liter (g/L) | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Participant 1: Day 1 | — | 2.09 |
| Participant 1: Day 83 | — | 2.64 |
| Participant 1: Day 125 | — | 2.64 |
| Participant 1: Day 155 | — | 2.78 |
| Participant 2: Day 1 | 1.64 | — |
| Participant 2: Day 83 | 1.85 | — |
| Participant 2: Day 125 | 2.2 | — |
| Participant 2: Day 155 | 2.15 | — |
| Participant 3: Day 1 | 2.09 | — |
| Participant 3: Day 125 | 1.84 | — |
Absolute concentrations of Immunoglobulin (Ig) E was reported.
| International unit per milliliter(IU/mL) | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Participant 1: Day 1 | — | 61 |
| Participant 1: Day 83 | — | 108 |
| Participant 1: Day 125 | — | 55.2 |
| Participant 1: Day 155 | — | 71.9 |
| Participant 2: Day 1 | 10.7 | — |
| Participant 2: Day 83 | 12.3 | — |
| Participant 2: Day 125 | 14.9 | — |
| Participant 2: Day 155 | 11.4 | — |
| Participant 3: Day 1 | 27.6 | — |
| Participant 3: Day 125 | 23.5 | — |
Absolute concentrations of Immunoglobulin (Ig) G was reported.
| grams per liter (g/L) | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Participant 1: Day 1 | — | 16.49 |
| Participant 1: Day 83 | — | 21.77 |
| Participant 1: Day 125 | — | 19.34 |
| Participant 1: Day 155 | — | 19.62 |
| Participant 2: Day 1 | 9.46 | — |
| Participant 2: Day 83 | 10.26 | — |
| Participant 2: Day 125 | 11.23 | — |
| Participant 2: Day 155 | 11.18 | — |
| Participant 3: Day 1 | 12.52 | — |
| Participant 3: Day 125 | 11.41 | — |
Absolute concentrations of Immunoglobulin (Ig) M was reported.
| grams per liter (g/L) | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Participant 1: Day 1 | — | 0.97 |
| Participant 1: Day 83 | — | 1.47 |
| Participant 1: Day 125 | — | 1.35 |
| Participant 1: Day 155 | — | 1.43 |
| Participant 2: Day 1 | 1.08 | — |
| Participant 2: Day 83 | 0.84 | — |
| Participant 2: Day 125 | 0.78 | — |
| Participant 2: Day 155 | 1 | — |
| Participant 3: Day 1 | 2.22 | — |
| Participant 3: 125 | 1.91 | — |
Change from baseline in immunoglobulin (Ig) A level was reported.
| grams per liter (g/L) | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Participant 1: Day 83 | — | 0.55 |
| Participant 1: Day 125 | — | 0.55 |
| Participant 1: Day 155 | — | 0.69 |
| Participant 2: Day 83 | 0.21 | — |
| Participant 2: Day 125 | 0.56 | — |
| Participant 2: Day 155 | 0.51 | — |
| Participant 3: Day 125 | -0.25 | — |
Change from baseline in immunoglobulin (Ig) E level was reported.
| International unit per milliliter(IU/mL) | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Participant 1: Day 83 | — | 47 |
| Participant 1: Day 125 | — | -5.8 |
| Participant 1: Day 155 | — | 10.9 |
| Participant 2: Day 83 | 1.6 | — |
| Participant 2: Day 125 | 4.2 | — |
| Participant 2: Day 155 | 0.7 | — |
| Participant 3: Day 125 | -4.1 | — |
Change from baseline in immunoglobulin (Ig) G level was reported.
| grams per liter (g/L) | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Participant 1: Day 83 | — | 5.28 |
| Participant 1: Day 125 | — | 2.85 |
| Participant 1: Day 155 | — | 3.13 |
| Participant 2: Day 83 | 0.8 | — |
| Participant 2: Day 125 | 1.77 | — |
| Participant 2: Day 155 | 1.72 | — |
| Participant 3: Day 125 | -1.11 | — |
Change from baseline in immunoglobulin (Ig) M level was reported.
| grams per liter (g/L) | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Participant 1: Day 83 | — | 0.5 |
| Participant 1: Day 125 | — | 0.38 |
| Participant 1: Day 155 | — | 0.46 |
| Participant 2: Day 83 | -0.24 | — |
| Participant 2: Day 125 | -0.3 | — |
| Participant 2: Day 155 | -0.08 | — |
| Participant 3: Day 125 | -0.31 | — |
Collected over Baseline up to 235 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: Evobrutinib + Avonex® Matched Placebo | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Active Comparator: Avonex® + Evobrutinib Matched Placebo | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo |
|---|---|---|
| Neutrophil count decreasedInvestigations | 0/2 | 1/1 |
| Tension headacheNervous system disorders | 0/2 | 1/1 |
| Abdominal painGastrointestinal disorders | 0/2 | 1/1 |
| VomitingGastrointestinal disorders | 0/2 | 1/1 |
| Drug eruptionGeneral disorders | 1/2 | 0/1 |
| Influenza like illnessGeneral disorders | 1/2 | 0/1 |
| Pain in jawMusculoskeletal and connective tissue disorders | 1/2 | 0/1 |
| ParaesthesiaNervous system disorders | 1/2 | 0/1 |
| Tinea crurisSkin and subcutaneous tissue disorders | 1/2 | 0/1 |
| PetechiaeSkin and subcutaneous tissue disorders | 1/2 | 0/1 |
| Age, Categorical(Participants) | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 1 | 3 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Experimental: Evobrutinib + Avonex® Matched Placebo | Active Comparator: Avonex® + Evobrutinib Matched Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 2 | 0 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
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