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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004700-19 | EudraCT Number |
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Following analysis of open label extension (OLE) data from RMS phase 2 study (MS200527- 0086), it was determined that a change in active comparator warranted in phase 3 RMS comprised of trial MS200527-0074. Consequently, this trial terminated early.
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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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 Relapsing Multiple Sclerosis (RMS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evobrutinib + Avonex® matched Placebo | Experimental | 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. |
|
| Avonex® + Evobrutinib matched Placebo | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evobrutinib | Drug | Participants received evobrutinib twice daily (BID). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please Contact U.S. Medical Information | Rockland | Massachusetts | 02370 | United States | ||
| Please Contact the Communication Center |
Not provided
| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| US Medical Information website, Medical Resources | View source |
Not provided
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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This study was to be conducted in 2 periods; double blind period and open label extension period. However, due to early termination of the study, the sponsor decided not to conduct the open label extension period. A total of 950 participants were planned to be included in 1:1 to treatment with evobrutinib or Avonex, however only 1 participant was enrolled in evobrutinib due to early termination.
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| ID | Title | Description |
|---|---|---|
| FG000 | Evobrutinib + Avonex® Matched Placebo | 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. |
| FG001 | Avonex® + Evobrutinib 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Following analysis of open label extension (OLE) data from RMS phase 2 study (MS200527- 0086), it was determined that a change in active comparator warranted in phase 3 RMS comprised of trial MS200527-0074. Consequently, this trial terminated early, therefore no participants enrolled in Avonex® + Evobrutinib matched Placebo arm.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Evobrutinib + Avonex® Matched Placebo | 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. |
| BG001 | Avonex® + Evobrutinib Matched Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Following analysis of open label extension (OLE) data from RMS phase 2 study (MS200527- 0086), it was determined that a change in active comparator warranted in phase 3 RMS comprised of trial MS200527-0074. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study. | Posted | At Week 96 |
|
Baseline up to 254 days
Following analysis of open label extension (OLE) data from RMS phase 2 study (MS200527- 0086), it was determined that a change in active comparator warranted in phase 3 RMS comprised of trial MS200527-0074. Consequently, this trial terminated early, therefore no participants enrolled in Avonex® + Evobrutinib matched Placebo arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Evobrutinib + Avonex® Matched Placebo | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
Following analysis of open label extension (OLE) data from RMS phase 2 study (MS200527- 0086), it was determined that a change in active comparator warranted in phase 3 RMS comprised of trial MS200527-0074. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 5, 2019 | May 31, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 28, 2020 | May 28, 2021 | SAP_001.pdf |
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Not provided
Not provided
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000632111 | evobrutinib |
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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| Avonex® | Drug | Participants received avonex® IM injection once a week. |
|
| Avonex® matched Placebo | Drug | Participants received IM injection of placebo matched to avonex® once a week. |
|
| Evobrutinib matched Placebo | Drug | Participants received placebo matched to evobrutinib twice a day. |
|
| 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. | 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. | Baseline, Week 96 |
| Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 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. | 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). | 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). | 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 & was serious, related to investigational medicinal product (IMP), or resulted in death, discontinuation, interruption or reduction of study therapy. TEAEs included both serious 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. | Baseline up to 254 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) | Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs included both serious TEAEs and non-serious TEAEs. 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. | Baseline up to 254 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. | At Day 1, Week 2 unscheduled 1, Week 12 and Early Discontinuation (ED) (up to approximately 36 weeks |
| Vital Signs: Pulse Rate | Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. | At Day 1, Week 2 unscheduled 1, Week 12 and Early Discontinuation ED (up to approximately 36 weeks) |
| Vital Signs: Respiratory Rate | Respiration rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. | At Day 1, Week 2 unscheduled 1, Week 12 and Early Discontinuation ED (up to approximately 36 weeks) |
| Vital Signs: Temperature | Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. | At Day 1, Week 2 unscheduled 1, Week 12 and Early Discontinuation (ED) (up to approximately 36 weeks) |
| Vital Signs: Weight | At Day 1, Week 2 unscheduled 1, Week 12 and Early Discontinuation (up to approximately 36 weeks) |
| 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. | Baseline up to 254 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. | Baseline up to 254 days |
| Absolute Concentrations of Immunoglobulin (Ig) A Level | Absolute concentrations of Immunoglobulin (Ig) A was reported. | At Day 1 and Day 92 |
| Absolute Concentrations of Immunoglobulin (Ig) G Level | Absolute concentrations of Immunoglobulin (Ig) E was reported. | At Day 1 and Day 92 |
| Absolute Concentrations of Immunoglobulin (Ig) M Level | Absolute concentrations of Immunoglobulin (Ig) M was reported. | At Day 1 and Day 92 |
| Absolute Concentrations of Immunoglobulin (Ig) E Level | Absolute concentrations of Immunoglobulin (Ig) E was reported. | At Day 1 and Day 92 |
| Change From Baseline in Immunoglobulin (Ig) A Level | Change from baseline in immunoglobulin (Ig) A level was reported. | At Day 1 and Day 92 |
| Change From Baseline in Immunoglobulin (Ig) E Level | Change from baseline in immunoglobulin (Ig) E level was reported. | At Day 1 and Day 92 |
| Change From Baseline in Immunoglobulin (Ig) G Level | Change from baseline in immunoglobulin (Ig) G level was reported. | At Day 1 and Day 92 |
| Change From Baseline in Immunoglobulin (Ig) M Level | Change from baseline in immunoglobulin (Ig) M level was reported. | At Day 1 and Day 92 |
| Darmstadt |
| 64293 |
| Germany |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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. |
| OG001 | Avonex® + Evobrutinib 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. |
|
| Secondary | 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. | Following analysis of open label extension (OLE) data from RMS phase 2 study (MS200527- 0086), it was determined that a change in active comparator warranted in phase 3 RMS comprised of trial MS200527-0074. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study. | Posted | Baseline up to 96 weeks |
|
|
| Secondary | 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. | Following analysis of open label extension (OLE) data from RMS phase 2 study (MS200527- 0086), it was determined that a change in active comparator warranted in phase 3 RMS comprised of trial MS200527-0074. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study. | Posted | Baseline up to 96 weeks |
|
|
| Secondary | 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. | Following analysis of open label extension (OLE) data from RMS phase 2 study (MS200527- 0086), it was determined that a change in active comparator warranted in phase 3 RMS comprised of trial MS200527-0074. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study. | Posted | Baseline, Week 96 |
|
|
| Secondary | Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 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. | Following analysis of open label extension (OLE) data from RMS phase 2 study (MS200527- 0086), it was determined that a change in active comparator warranted in phase 3 RMS comprised of trial MS200527-0074. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study. | Posted | Baseline, Week 96 |
|
|
| Secondary | 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). | Following analysis of open label extension (OLE) data from RMS phase 2 study (MS200527- 0086), it was determined that a change in active comparator warranted in phase 3 RMS comprised of trial MS200527-0074. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study. | Posted | At Week 24, 48 and 96 |
|
|
| Secondary | 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). | Following analysis of open label extension (OLE) data from RMS phase 2 study (MS200527- 0086), it was determined that a change in active comparator warranted in phase 3 RMS comprised of trial MS200527-0074. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study. | Posted | At Week 24, 48 and 96 |
|
|
| Secondary | 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 & was serious, related to investigational medicinal product (IMP), or resulted in death, discontinuation, interruption or reduction of study therapy. TEAEs included both serious 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. | SAF analysis set included all participants who were administered any dose of any study intervention. | Posted | Count of Participants | Participants | Baseline up to 254 days |
|
|
|
| Secondary | 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) | Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs included both serious TEAEs and non-serious TEAEs. 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. | Safety (SAF) analysis set included all participants who were administered any dose of any study intervention. | Posted | Count of Participants | Participants | Baseline up to 254 days |
|
|
|
| Secondary | 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. | SAF analysis set included all participants who were administered any dose of any study intervention. | Posted | Number | Millimeters of mercury (mmHg) | At Day 1, Week 2 unscheduled 1, Week 12 and Early Discontinuation (ED) (up to approximately 36 weeks |
|
|
|
| Secondary | Vital Signs: Pulse Rate | Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. | SAF analysis set included all participants who were administered any dose of any study intervention. | Posted | Number | Beats per minute | At Day 1, Week 2 unscheduled 1, Week 12 and Early Discontinuation ED (up to approximately 36 weeks) |
|
|
|
| Secondary | Vital Signs: Respiratory Rate | Respiration rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. | SAF analysis set included all participants who were administered any dose of any study intervention. | Posted | Number | Breaths Per Minute | At Day 1, Week 2 unscheduled 1, Week 12 and Early Discontinuation ED (up to approximately 36 weeks) |
|
|
|
| Secondary | Vital Signs: Temperature | Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. | SAF analysis set included all participants who were administered any dose of any study intervention. | Posted | Number | Degree celsius | At Day 1, Week 2 unscheduled 1, Week 12 and Early Discontinuation (ED) (up to approximately 36 weeks) |
|
|
|
| Secondary | Vital Signs: Weight | SAF analysis set included all participants who were administered any dose of any study intervention. | Posted | Number | kilogram (kg) | At Day 1, Week 2 unscheduled 1, Week 12 and Early Discontinuation (up to approximately 36 weeks) |
|
|
|
| Secondary | 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. | SAF analysis set included all participants who were administered any dose of any study intervention. | Posted | Count of Participants | Participants | Baseline up to 254 days |
|
|
|
| Secondary | 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. | SAF analysis set included all participants who were administered any dose of any study intervention. | Posted | Count of Participants | Participants | Baseline up to 254 days |
|
|
|
| Secondary | Absolute Concentrations of Immunoglobulin (Ig) A Level | Absolute concentrations of Immunoglobulin (Ig) A was reported. | SAF analysis set included all participants who were administered any dose of any study intervention. | Posted | Number | gram per liter (g/L) | At Day 1 and Day 92 |
|
|
|
| Secondary | Absolute Concentrations of Immunoglobulin (Ig) G Level | Absolute concentrations of Immunoglobulin (Ig) E was reported. | SAF analysis set included all participants who were administered any dose of any study intervention. | Posted | Number | grams per liter (g/L) | At Day 1 and Day 92 |
|
|
|
| Secondary | Absolute Concentrations of Immunoglobulin (Ig) M Level | Absolute concentrations of Immunoglobulin (Ig) M was reported. | SAF analysis set included all participants who were administered any dose of any study intervention. | Posted | Number | grams per liter (g/L) | At Day 1 and Day 92 |
|
|
|
| Secondary | Absolute Concentrations of Immunoglobulin (Ig) E Level | Absolute concentrations of Immunoglobulin (Ig) E was reported. | SAF analysis set included all participants who were administered any dose of any study intervention. | Posted | Number | International units per milliliter | At Day 1 and Day 92 |
|
|
|
| Secondary | Change From Baseline in Immunoglobulin (Ig) A Level | Change from baseline in immunoglobulin (Ig) A level was reported. | SAF analysis set included all participants who were administered any dose of any study intervention. | Posted | Number | gram per liter (g/L) | At Day 1 and Day 92 |
|
|
|
| Secondary | Change From Baseline in Immunoglobulin (Ig) E Level | Change from baseline in immunoglobulin (Ig) E level was reported. | SAF analysis set included all participants who were administered any dose of any study intervention. | Posted | Number | International units per milliliter | At Day 1 and Day 92 |
|
|
|
| Secondary | Change From Baseline in Immunoglobulin (Ig) G Level | Change from baseline in immunoglobulin (Ig) G level was reported. | SAF analysis set included all participants who were administered any dose of any study intervention. | Posted | Number | grams per liter (g/L) | At Day 1 and Day 92 |
|
|
|
| Secondary | Change From Baseline in Immunoglobulin (Ig) M Level | Change from baseline in immunoglobulin (Ig) M level was reported. | SAF analysis set included all participants who were administered any dose of any study intervention. | Posted | Number | grams per liter (g/L) | At Day 1 and Day 92 |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Avonex® + Evobrutinib 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| Peripheral edema | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Hypercholesterolemia | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
|
Not provided
Not provided
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
| Grade 4 |
|
| Grade 5 |
|
| Title | Measurements |
|---|---|
|
| DBP: ED (up to approximately 36 weeks) |
|
| SBP: Day 1 |
|
| SBP: Week 2 unscheduled 1 |
|
| SBP: Week 12 |
|
| SBP:ED (up to approximately 36 weeks) |
|
| Title | Measurements |
|---|---|
|
| Pulse rate: ED (up to approximately 36 weeks) |
|
| Title | Measurements |
|---|---|
|
| Respiratory rate: ED (up to approximately 36 weeks) |
|
| Title | Measurements |
|---|---|
|
| ED (up to approximately 36 weeks) |
|
| Title | Measurements |
|---|---|
|
| ED (up to approximately 36 weeks) |
|