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Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04032158
Recruitment Status : Terminated (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 MS200527-0073. Consequently, this trial terminated early.)
First Posted : July 25, 2019
Results First Posted : August 5, 2021
Last Update Posted : August 5, 2021
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Relapsing-remitting Multiple Sclerosis
Interventions Drug: Evobrutinib
Drug: Avonex®
Drug: Avonex® matched Placebo
Drug: Evobrutinib matched Placebo
Enrollment 3
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 2 1
Completed 0 0
Not Completed 2 1
Reason Not Completed
Study Termination             2             1
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 2 1 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
1
 100.0%
3
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Female
1
  50.0%
1
 100.0%
2
  66.7%
Male
1
  50.0%
0
   0.0%
1
  33.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
 100.0%
1
  33.3%
White
2
 100.0%
0
   0.0%
2
  66.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Annualized Relapse Rate (ARR)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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 MS200527-0073. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Time to First Occurrence of 12-Week Confirmed Expanded Disability Status Scale (EDSS) Progression
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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 MS200527-0073. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Time to First Occurrence of 24-Week Confirmed Expanded Disability Status Scale (EDSS) Progression
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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 MS200527-0073. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Short Form Score at Week 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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 MS200527-0073. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Fatigue Score at Week 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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 MS200527-0073. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Total Number of Gadolinium-Enhancing (Gd+) Time Constant 1 (T1) Lesions Assessed by Magnetic Resonance Imaging (MRI) Scans at Week 24, 48, and 96
Hide Description Total number of Gd+ T1 lesions was to be assessed using magnetic resonance imaging (MRI).
Time Frame At Week 24, 48 and 96
Hide Outcome Measure Data
Hide Analysis Population Description
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 MS200527-0073. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Total Number of New or Enlarging Time Constant 2 (T2) Lesions Assessed by Magnetic Resonance Imaging (MRI) Scans at Week 24, 48, and 96
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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 MS200527-0073. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety (SAF) analysis set included all participants who were administered any dose of any study intervention.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 2 1
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with AESIs
0
   0.0%
0
   0.0%
Participants with TEAEs
2
 100.0%
1
 100.0%
Participants with Serious TEAEs
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title 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)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set included all participants who were administered any dose of any study intervention
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 2 1
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
2
 100.0%
0
   0.0%
Grade 2
0
   0.0%
1
 100.0%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
Grade 5
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set included all participants who were administered any dose of any study intervention. No summary analysis was done. Following analysis of 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 MS200527-0073. Consequently, this trial terminated early. Therefore, participant wise data reported and number analyzed= specific participant evaluated in respective arm at specified timepoint.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: Millimeters of mercury (mmHg)
Participants 1 - DBP: Day 1 Number Analyzed 0 participants 1 participants
82
Participants 1 - DBP: Day 83 Number Analyzed 0 participants 1 participants
87
Participants 1 - DBP: Day 125 Number Analyzed 0 participants 1 participants
80
Participants 1 - DBP: Day 155 Number Analyzed 0 participants 1 participants
75
Participants 1 - SBP: Day 1 Number Analyzed 0 participants 1 participants
112
Participants 1 - SBP: Day 83 Number Analyzed 0 participants 1 participants
120
Participants 1 - SBP: Day 125 Number Analyzed 0 participants 1 participants
118
Participants 1 - SBP: Day 155 Number Analyzed 0 participants 1 participants
109
Participants 2 - DBP: Day 1 Number Analyzed 1 participants 0 participants
84
Participants 2 - DBP: Day 83 Number Analyzed 1 participants 0 participants
77
Participants 2 - DBP: Day 125 Number Analyzed 1 participants 0 participants
84
Participants 2 - DBP: Day 155 Number Analyzed 1 participants 0 participants
90
Participants 2 - SBP: Day 1 Number Analyzed 1 participants 0 participants
124
Participants 2 - SBP: Day 83 Number Analyzed 1 participants 0 participants
133
Participants 2 - SBP: Day 125 Number Analyzed 1 participants 0 participants
138
Participants 2 - SBP: Day 155 Number Analyzed 1 participants 0 participants
137
Participant 3 - DBP: Day 1 Number Analyzed 1 participants 0 participants
65
Participants 3 - DBP: Day 125 Number Analyzed 1 participants 0 participants
76
Participants 3 - SBP: Day 1 Number Analyzed 1 participants 0 participants
101
Participant 3 - SBP: Day 125 Number Analyzed 1 participants 0 participants
117
11.Secondary Outcome
Title Vital Signs: Pulse Rate
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set included all participants who were administered any dose of any study intervention. No summary analysis was done. Following analysis of 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 MS200527-0073. Consequently, this trial terminated early. Therefore, participant wise data reported and number analyzed= specific participant evaluated in respective arm at specified timepoint.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: Beats per minute
Participants 1 - Pulse rate: Day 1 Number Analyzed 0 participants 1 participants
71
Participants 1 - Pulse rate: Day 83 Number Analyzed 0 participants 1 participants
69
Participants 1 - Pulse rate: Day 125 Number Analyzed 0 participants 1 participants
72
Participants 1 - Pulse rate: Day 155 Number Analyzed 0 participants 1 participants
75
Participants 2 - Pulse rate: Day 1 Number Analyzed 1 participants 0 participants
71
Participants 2 - Pulse rate: Day 83 Number Analyzed 1 participants 0 participants
66
Participants 2 - Pulse rate: Day 125 Number Analyzed 1 participants 0 participants
82
Participants 2 - Pulse rate: Day 155 Number Analyzed 1 participants 0 participants
82
Participant 3 - Pulse rate: Day 1 Number Analyzed 1 participants 0 participants
76
Participants 3 - Pulse rate: Day 125 Number Analyzed 1 participants 0 participants
75
12.Secondary Outcome
Title Vital Signs: Respiratory Rate
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set included all participants who were administered any dose of any study intervention. No summary analysis was done. Following analysis of 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 MS200527-0073. Consequently, this trial terminated early. Therefore, participant wise data reported and number analyzed= specific participant evaluated in respective arm at specified timepoint.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: Breaths Per Minute
Participants 1 - Respiratory rate: Day 1 Number Analyzed 0 participants 1 participants
20
Participants 1 - Respiratory rate: Day 83 Number Analyzed 0 participants 1 participants
18
Participants 1 - Respiratory rate: Day 125 Number Analyzed 0 participants 1 participants
18
Participants 1 - Respiratory rate: Day 155 Number Analyzed 0 participants 1 participants
20
Participants 2 - Respiratory rate: Day 1 Number Analyzed 1 participants 0 participants
18
Participants 2 - Respiratory rate: Day 83 Number Analyzed 1 participants 0 participants
20
Participants 2 - Respiratory rate: Day 125 Number Analyzed 1 participants 0 participants
18
Participants 2 - Respiratory rate: Day 155 Number Analyzed 1 participants 0 participants
20
Participant 3 - Respiratory rate: Day 1 Number Analyzed 1 participants 0 participants
18
Participants 3 - Respiratory rate: Day 125 Number Analyzed 1 participants 0 participants
18
13.Secondary Outcome
Title Vital Signs: Temperature
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set included all participants who were administered any dose of any study intervention. No summary analysis was done. Following analysis of 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 MS200527-0073. Consequently, this trial terminated early. Therefore, participant wise data reported and number analyzed= specific participant evaluated in respective arm at specified timepoint.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: Degree celsius
Participants 1: Day 1 Number Analyzed 0 participants 1 participants
35.7
Participants 1: Day 83 Number Analyzed 0 participants 1 participants
36.4
Participants 1: Day 125 Number Analyzed 0 participants 1 participants
36.9
Participants 1: Day 155 Number Analyzed 0 participants 1 participants
36.4
Participants 2: Day 1 Number Analyzed 1 participants 0 participants
36.9
Participants 2: Day 83 Number Analyzed 1 participants 0 participants
36.7
Participants 2: Day 125 Number Analyzed 1 participants 0 participants
36.9
Participants 2: Day 155 Number Analyzed 1 participants 0 participants
36.8
Participant 3: Day 1 Number Analyzed 1 participants 0 participants
36.5
Participants 3: Day 125 Number Analyzed 1 participants 0 participants
37.0
14.Secondary Outcome
Title Vital Signs: Weight
Hide Description [Not Specified]
Time Frame At Day 1, 83, 125 and 155
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set included all participants who were administered any dose of any study intervention. No summary analysis was done. Following analysis of 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 MS200527-0073. Consequently, this trial terminated early. Therefore, participant wise data reported and number analyzed= specific participant evaluated in respective arm at specified timepoint.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: kilogram (kg)
Participants 1: Day 1 Number Analyzed 0 participants 1 participants
75.7
Participants 1: Day 83 Number Analyzed 0 participants 1 participants
74.9
Participants 1: Day 125 Number Analyzed 0 participants 1 participants
77.3
Participants 1: Day 155 Number Analyzed 0 participants 1 participants
77.2
Participants 2: Day 1 Number Analyzed 1 participants 0 participants
89.0
Participants 2: Day 83 Number Analyzed 1 participants 0 participants
89.0
Participants 2: Day 125 Number Analyzed 1 participants 0 participants
92.2
Participants 2: Day 155 Number Analyzed 1 participants 0 participants
92.1
Participant 3: Day 1 Number Analyzed 1 participants 0 participants
40.8
Participants 3: Day 125 Number Analyzed 1 participants 0 participants
40.3
15.Secondary Outcome
Title Number of Participants With Abnormal Lab Values
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set included all participants who were administered any dose of any study intervention.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 2 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
16.Secondary Outcome
Title Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set included all participants who were administered any dose of any study intervention.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 2 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
17.Secondary Outcome
Title Absolute Concentrations of Immunoglobulin (Ig) A Level
Hide Description Absolute concentrations of Immunoglobulin (Ig) A was reported.
Time Frame At Day 1, 83, 125 and 155
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set included all participants who were administered any dose of any study intervention. No summary analysis was done. Following analysis of 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 MS200527-0073. Consequently, this trial terminated early. Therefore, participant wise data reported and number analyzed= specific participant evaluated in respective arm at specified timepoint.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: grams per liter (g/L)
Participant 1: Day 1 Number Analyzed 0 participants 1 participants
2.09
Participant 1: Day 83 Number Analyzed 0 participants 1 participants
2.64
Participant 1: Day 125 Number Analyzed 0 participants 1 participants
2.64
Participant 1: Day 155 Number Analyzed 0 participants 1 participants
2.78
Participant 2: Day 1 Number Analyzed 1 participants 0 participants
1.64
Participant 2: Day 83 Number Analyzed 1 participants 0 participants
1.85
Participant 2: Day 125 Number Analyzed 1 participants 0 participants
2.2
Participant 2: Day 155 Number Analyzed 1 participants 0 participants
2.15
Participant 3: Day 1 Number Analyzed 1 participants 0 participants
2.09
Participant 3: Day 125 Number Analyzed 1 participants 0 participants
1.84
18.Secondary Outcome
Title Absolute Concentrations of Immunoglobulin (Ig) E Level
Hide Description Absolute concentrations of Immunoglobulin (Ig) E was reported.
Time Frame At Day 1, 83, 125 and 155
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set included all participants who were administered any dose of any study intervention. No summary analysis was done. Following analysis of 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 MS200527-0073. Consequently, this trial terminated early. Therefore, participant wise data reported and number analyzed= specific participant evaluated in respective arm at specified timepoint.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: International unit per milliliter(IU/mL)
Participant 1: Day 1 Number Analyzed 0 participants 1 participants
61
Participant 1: Day 83 Number Analyzed 0 participants 1 participants
108
Participant 1: Day 125 Number Analyzed 0 participants 1 participants
55.2
Participant 1: Day 155 Number Analyzed 0 participants 1 participants
71.9
Participant 2: Day 1 Number Analyzed 1 participants 0 participants
10.7
Participant 2: Day 83 Number Analyzed 1 participants 0 participants
12.3
Participant 2: Day 125 Number Analyzed 1 participants 0 participants
14.9
Participant 2: Day 155 Number Analyzed 1 participants 0 participants
11.4
Participant 3: Day 1 Number Analyzed 1 participants 0 participants
27.6
Participant 3: Day 125 Number Analyzed 1 participants 0 participants
23.5
19.Secondary Outcome
Title Absolute Concentrations of Immunoglobulin (Ig) G Level
Hide Description Absolute concentrations of Immunoglobulin (Ig) G was reported.
Time Frame At Day 1, 83, 125 and 155
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set included all participants who were administered any dose of any study intervention. No summary analysis was done. Following analysis of 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 MS200527-0073. Consequently, this trial terminated early. Therefore, participant wise data reported and number analyzed= specific participant evaluated in respective arm at specified timepoint.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: grams per liter (g/L)
Participant 1: Day 1 Number Analyzed 0 participants 1 participants
16.49
Participant 1: Day 83 Number Analyzed 0 participants 1 participants
21.77
Participant 1: Day 125 Number Analyzed 0 participants 1 participants
19.34
Participant 1: Day 155 Number Analyzed 0 participants 1 participants
19.62
Participant 2: Day 1 Number Analyzed 1 participants 0 participants
9.46
Participant 2: Day 83 Number Analyzed 1 participants 0 participants
10.26
Participant 2: Day 125 Number Analyzed 1 participants 0 participants
11.23
Participant 2: Day 155 Number Analyzed 1 participants 0 participants
11.18
Participant 3: Day 1 Number Analyzed 1 participants 0 participants
12.52
Participant 3: Day 125 Number Analyzed 1 participants 0 participants
11.41
20.Secondary Outcome
Title Absolute Concentrations of Immunoglobulin (Ig) M Level
Hide Description Absolute concentrations of Immunoglobulin (Ig) M was reported.
Time Frame At Day 1, 83, 125 and 155
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set included all participants who were administered any dose of any study intervention. No summary analysis was done. Following analysis of 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 MS200527-0073. Consequently, this trial terminated early. Therefore, participant wise data reported and number analyzed= specific participant evaluated in respective arm at specified timepoint.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: grams per liter (g/L)
Participant 1: Day 1 Number Analyzed 0 participants 1 participants
0.97
Participant 1: Day 83 Number Analyzed 0 participants 1 participants
1.47
Participant 1: Day 125 Number Analyzed 0 participants 1 participants
1.35
Participant 1: Day 155 Number Analyzed 0 participants 1 participants
1.43
Participant 2: Day 1 Number Analyzed 1 participants 0 participants
1.08
Participant 2: Day 83 Number Analyzed 1 participants 0 participants
0.84
Participant 2: Day 125 Number Analyzed 1 participants 0 participants
0.78
Participant 2: Day 155 Number Analyzed 1 participants 0 participants
1
Participant 3: Day 1 Number Analyzed 1 participants 0 participants
2.22
Participant 3: 125 Number Analyzed 1 participants 0 participants
1.91
21.Secondary Outcome
Title Change From Baseline in Immunoglobulin (Ig) A Level
Hide Description Change from baseline in immunoglobulin (Ig) A level was reported.
Time Frame At Day 1, 83, 125 and 155
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set included all participants who were administered any dose of any study intervention. No summary analysis was done. Following analysis of 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 MS200527-0073. Consequently, this trial terminated early. Therefore, participant wise data reported and number analyzed= specific participant evaluated in respective arm at specified timepoint.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: grams per liter (g/L)
Participant 1: Day 83 Number Analyzed 0 participants 1 participants
0.55
Participant 1: Day 125 Number Analyzed 0 participants 1 participants
0.55
Participant 1: Day 155 Number Analyzed 0 participants 1 participants
0.69
Participant 2: Day 83 Number Analyzed 1 participants 0 participants
0.21
Participant 2: Day 125 Number Analyzed 1 participants 0 participants
0.56
Participant 2: Day 155 Number Analyzed 1 participants 0 participants
0.51
Participant 3: Day 125 Number Analyzed 1 participants 0 participants
-0.25
22.Secondary Outcome
Title Change From Baseline in Immunoglobulin (Ig) E Level
Hide Description Change from baseline in immunoglobulin (Ig) E level was reported.
Time Frame At Day 1, 83, 125 and 155
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set included all participants who were administered any dose of any study intervention. No summary analysis was done. Following analysis of 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 MS200527-0073. Consequently, this trial terminated early. Therefore, participant wise data reported and number analyzed= specific participant evaluated in respective arm at specified timepoint.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: International unit per milliliter(IU/mL)
Participant 1: Day 83 Number Analyzed 0 participants 1 participants
47
Participant 1: Day 125 Number Analyzed 0 participants 1 participants
-5.8
Participant 1: Day 155 Number Analyzed 0 participants 1 participants
10.9
Participant 2: Day 83 Number Analyzed 1 participants 0 participants
1.6
Participant 2: Day 125 Number Analyzed 1 participants 0 participants
4.2
Participant 2: Day 155 Number Analyzed 1 participants 0 participants
0.7
Participant 3: Day 125 Number Analyzed 1 participants 0 participants
-4.1
23.Secondary Outcome
Title Change From Baseline in Immunoglobulin (Ig) G Level
Hide Description Change from baseline in immunoglobulin (Ig) G level was reported.
Time Frame At Day 1, 83, 125 and 155
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set included all participants who were administered any dose of any study intervention. No summary analysis was done. Following analysis of 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 MS200527-0073. Consequently, this trial terminated early. Therefore, participant wise data reported and number analyzed= specific participant evaluated in respective arm at specified timepoint.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: grams per liter (g/L)
Participant 1: Day 83 Number Analyzed 0 participants 1 participants
5.28
Participant 1: Day 125 Number Analyzed 0 participants 1 participants
2.85
Participant 1: Day 155 Number Analyzed 0 participants 1 participants
3.13
Participant 2: Day 83 Number Analyzed 1 participants 0 participants
0.8
Participant 2: Day 125 Number Analyzed 1 participants 0 participants
1.77
Participant 2: Day 155 Number Analyzed 1 participants 0 participants
1.72
Participant 3: Day 125 Number Analyzed 1 participants 0 participants
-1.11
24.Secondary Outcome
Title Change From Baseline in Immunoglobulin (Ig) M Level
Hide Description Change from baseline in immunoglobulin (Ig) M level was reported.
Time Frame At Day 1, 83, 125 and 155
Hide Outcome Measure Data
Hide Analysis Population Description
SAF analysis set included all participants who were administered any dose of any study intervention. No summary analysis was done. Following analysis of 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 MS200527-0073. Consequently, this trial terminated early. Therefore, participant wise data reported and number analyzed= specific participant evaluated in respective arm at specified timepoint.
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: grams per liter (g/L)
Participant 1: Day 83 Number Analyzed 0 participants 1 participants
0.5
Participant 1: Day 125 Number Analyzed 0 participants 1 participants
0.38
Participant 1: Day 155 Number Analyzed 0 participants 1 participants
0.46
Participant 2: Day 83 Number Analyzed 1 participants 0 participants
-0.24
Participant 2: Day 125 Number Analyzed 1 participants 0 participants
-0.3
Participant 2: Day 155 Number Analyzed 1 participants 0 participants
-0.08
Participant 3: Day 125 Number Analyzed 1 participants 0 participants
-0.31
Time Frame Baseline up to 235 days
Adverse Event Reporting Description SAF analysis set included all participants who were administered any dose of any study intervention.
 
Arm/Group Title Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Hide Serious Adverse Events
Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental: Evobrutinib + Avonex® Matched Placebo Active Comparator: Avonex® + Evobrutinib Matched Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/2 (100.00%)   1/1 (100.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/2 (0.00%)  1/1 (100.00%) 
Vomiting * 1  0/2 (0.00%)  1/1 (100.00%) 
General disorders     
Drug eruption * 1  1/2 (50.00%)  0/1 (0.00%) 
Influenza like illness * 1  1/2 (50.00%)  0/1 (0.00%) 
Investigations     
Neutrophil count decreased * 1  0/2 (0.00%)  1/1 (100.00%) 
Musculoskeletal and connective tissue disorders     
Pain in jaw * 1  1/2 (50.00%)  0/1 (0.00%) 
Nervous system disorders     
Tension headache * 1  0/2 (0.00%)  1/1 (100.00%) 
Paraesthesia * 1  1/2 (50.00%)  0/1 (0.00%) 
Skin and subcutaneous tissue disorders     
Tinea cruris * 1  1/2 (50.00%)  0/1 (0.00%) 
Petechiae * 1  1/2 (50.00%)  0/1 (0.00%) 
1
Term from vocabulary, MedDRA 23.0
*
Indicates events were collected by 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 MS200527-0073. Consequently, this trial terminated early, therefore, it was decided as per Statistical Analysis Plan not to report the efficacy data for this study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Communication Center
Organization: Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
Layout table for additonal information
Responsible Party: EMD Serono ( EMD Serono Research & Development Institute, Inc. )
ClinicalTrials.gov Identifier: NCT04032158    
Other Study ID Numbers: MS200527_0073
2018-004701-11 ( EudraCT Number )
First Submitted: July 23, 2019
First Posted: July 25, 2019
Results First Submitted: May 31, 2021
Results First Posted: August 5, 2021
Last Update Posted: August 5, 2021