Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS) (EVOLUTION RMS1)
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|ClinicalTrials.gov Identifier: NCT04032158|
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : September 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Relapsing-remitting Multiple Sclerosis||Drug: Evobrutinib Drug: Avonex® Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||950 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With an Interferon Beta 1a (Avonex®), in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety|
|Actual Study Start Date :||August 26, 2019|
|Estimated Primary Completion Date :||September 4, 2023|
|Estimated Study Completion Date :||October 26, 2026|
|Experimental: Evobrutinib + Avonex® matched Placebo: Double-Blinded Period||
Evobrutinib twice daily (BID) in double-blind treatment period.
Placebo match to Avonex® once a week in double-blind treatment period.
|Active Comparator: Avonex® + Evobrutinib matched Placebo: Double-Blinded Period||
Avonex® once a week in double-blind treatment period.
Placebo match to Evobrutinib BID in double-blind treatment period.
|Experimental: Evobrutinib: Open-Label Extension Period||
Evobrutinib BID in Open-Label Extension Period.
- Annualized Relapse Rate (ARR) [ Time Frame: At Week 96 ]The annualized relapse rates over 96 weeks will be calculated based on qualified relapses. Qualifying relapse is defined as occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than 24 hours, no fever, infection, injury, adverse events, and preceded by a stable or improving neurological state for greater than or equal to (=>) 30 days).
- Time to First Occurrence of 12-Week Confirmed Expanded Disability Status Scale (EDSS) Progression [ Time Frame: Baseline up to 96 weeks ]
- Total Number of New or Enlarging T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) Scans [ Time Frame: At Weeks 24, 48, and 96 ]
- Total Number of Gadolinium-Enhancing (Gd+) T1 Lesions Assessed by Magnetic Resonance Imaging (MRI) Scans [ Time Frame: At Weeks 24, 48, and 96 ]
- Time to First Occurrence of 24-Week Confirmed Expanded Disability Status Scale (EDSS) Progression [ Time Frame: Baseline up to 96 weeks ]
- Change from Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Physical Function (PF) Short Form Score [ Time Frame: Baseline, Week 96 ]
- Change from Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Fatigue Short Form Score [ Time Frame: Baseline, Week 96 ]
- Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline up to Week 100 ]An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment.
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings [ Time Frame: Baseline up to Week 100 ]Number of participants with clinically significant change from baseline in vital signs, laboratory parameters and electrocardiogram findings will be reported.
- Absolute Concentrations of Immunoglobulin (Ig) Levels [ Time Frame: Baseline up to Week 100 ]
- Change From Baseline in Immunoglobulin (Ig) Levels [ Time Frame: Baseline up to Week 100 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032158
|Contact: US Medical Informationemail@example.com|
|Contact: Communication Center||49 6151 72 firstname.lastname@example.org|
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|Study Director:||Medical Responsible||Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany|