Clinical trial NCT04338061: Study of Evobrutinib in Participants With RMS (evolutionRMS 2)
Official title: A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 2)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Relapsing Multiple Sclerosis
Keywords: Evobrutinib
Teriflunomide
Aubagio®
Relapsing Multiple Sclerosis
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: EMD Serono Research & Development Institute, Inc.
First posted: 2020-04-08
Enrollment: 1166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants who complete the double-blind treatment period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period.


Eligibility criteria: 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 Screening and Baseline (Day 1). Participants with an EDSS score less than or equal to \[\<=\] 2 at Screening and Baseline (Day 1) 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 (Day 1)
* Female participants must be neither pregnant nor breast-feeding or 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 and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
* Male participants must refrain from donating sperm and/or abstain from intercourse with women of child-bearing potential or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
* 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
* Disease duration more than (\>) 10 years in participants with an EDSS =\< 2.0 at screening and Baseline (Day 1)
* Immunologic disorder other than MS, or any other condition requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy, with the exception of well-controlled Type 2 diabetes mellitus or well controlled thyroid disease
* Other protocol defined exclusion criteria could apply.

Primary outcomes:
measure: Double Blind Treatment Period (DBTP) and Double Blind Extension (DBE) Period: Annualized Relapse Rate (ARR)
timeFrame: Baseline up to 170 weeks
Secondary outcomes:
measure: DBTP and DBE Period: Percentage of Participants Without 12-Week Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS)
timeFrame: Week 96 and Week 156 (combined DBTP and DBE periods)
measure: DBTP and DBE Period: Percentage of Participants Without 24-Week Confirmed Disability Progression (CDP) as Measured by Expanded Disability Status Scale (EDSS)
timeFrame: Week 96 and Week 156 (combined DBTP and DBE periods)
measure: DBTP and DBE Period: Percentage of Participants With 24-Week Confirmed Disability Improvement (CDI) as Measured by Expanded Disability Status Scale (EDSS)
timeFrame: Week 96 and Week 156 (combined DBTP and DBE periods)
measure: DBTP and DBE Period: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 48, Week 96, Week 120, Week 144 and Week 156
timeFrame: Baseline, Week 48, Week 96, Week 120, Week 144 and Week 156 (Combined DBTP and DBE periods)
measure: DBTP and DBE Period: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score at Week 48, Week 96, Week 120, Week 144 and Week 156
timeFrame: Baseline, Week 48, Week 96, Week 120, Week 144 and Week 156 ((combined DBTP and DBE periods)
measure: DBTP and DBE Period: Total Number of T1 Gadolinium-positive (Gd+) Lesions
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Period: New or Enlarging T2 Lesions Rate
timeFrame: Baseline up to 170 weeks
measure: DBTP Period: Neurofilament Light Chain (NfL) Concentration at Week 12
timeFrame: Week 12
measure: DBTP and DBE Periods: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Vital Signs: Pulse Rate
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Vital Signs: Respiratory Rate
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Vital Signs: Weight
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Vital Signs: Temperature
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Electrocardiograms (ECGs): Heart Rate
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Electrocardiograms (ECGs): QT Interval - Fridericia's Correction Formula, PR Interval and QRS Duration
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Hematology Parameter: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Hematology Parameter: Platelets, Leukocytes, Neutrophils, Eosinophils, Basophils, Monocytes, Lymphocytes and Reticulocytes
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Hematology Parameters: Hematocrit
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Bilirubin and Creatinine
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Aspartate Aminotransferase, Alanine Aminotransferase, Alkaline Phosphatase, Amylase, Lipase, Gamma Glutamyl Transferase and Lactate Dehydrogenase
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Sodium, Potassium, Calcium, Magnesium, Glucose, Chloride, Urea Nitrogen, Phosphate, Bicarbonate and Corrected Calcium
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Total Protein and Albumin
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Biochemistry Parameters: Glomerular Filtration Rate
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine
timeFrame: Baseline up to 170 weeks
measure: DBTP and DBE Periods: Absolute Concentrations of Immunoglobulin (Ig) Levels
timeFrame: At Week 170
measure: DBTP and DBE Periods: Change From Baseline in Immunoglobulin (Ig) Levels
timeFrame: Baseline up to 170 weeks
Other outcomes:
Locations:
city: Cullman
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facility: Research Site 752
state: Alabama
city: Scottsdale
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facility: Research Site 741
state: Arizona
city: Tucson
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facility: Research Site 704
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city: Gomel
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city: Grodno
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country: Belarus
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facility: Research Site 145
city: Belo Horizonte
country: Brazil
facility: Research Site 603
city: Curitiba
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facility: Research Site 599
city: Goiânia
country: Brazil
facility: Research Site 604
city: Joinville
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facility: Research Site 600
city: Passo Fundo
country: Brazil
facility: Research Site 614
city: Porto Alegre
country: Brazil
facility: Research Site 591
city: Porto Alegre
country: Brazil
facility: Research Site 594
city: Porto Alegre
country: Brazil
facility: Research Site 596
city: Vitória
country: Brazil
facility: Research Site 609
city: Blagoevgrad
country: Bulgaria
facility: Research Site 155
city: Dupnitsa
country: Bulgaria
facility: Research Site 156
city: Pleven
country: Bulgaria
facility: Research Site 157
city: Pleven
country: Bulgaria
facility: Research Site 801
city: Pleven
country: Bulgaria
facility: Research Site 804
city: Plovdiv
country: Bulgaria
facility: Research Site 805
city: Sofia
country: Bulgaria
facility: Research Site 151
city: Sofia
country: Bulgaria
facility: Research Site 152
city: Sofia
country: Bulgaria
facility: Research Site 153
city: Sofia
country: Bulgaria
facility: Research Site 158
city: Sofia
country: Bulgaria
facility: Research Site 159
city: Sofia
country: Bulgaria
facility: Research Site 160
city: Sofia
country: Bulgaria
facility: Research Site 802
city: Sofia
country: Bulgaria
facility: Research Site 803
city: Sofia
country: Bulgaria
facility: Research Site 808
city: Veliko Tarnovo
country: Bulgaria
facility: Research Site 154
city: Burnaby
country: Canada
facility: Research Site 106
city: London
country: Canada
facility: Research Site 107
city: Montreal
country: Canada
facility: Research Site 105
city: Ottawa
country: Canada
facility: Research Site 101
city: Bordeaux Cedex
country: France
facility: Research Site 455
city: Brest cedex 2
country: France
facility: Research Site 459
city: Clermont Ferrand Cedex
country: France
facility: Reserach Site 451
city: Limoges cedex
country: France
facility: Research Site 458
city: Nimes
country: France
facility: Research Site 456
city: Paris
country: France
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city: Pringy cedex
country: France
facility: Research Site 457
city: Strasbourg cedex
country: France
facility: Research Site 452
city: Tours cedex 9
country: France
facility: Research Site 454
city: Augsburg
country: Germany
facility: Research Site 172
city: Berlin
country: Germany
facility: Research Site 177
city: Berlin
country: Germany
facility: Research Site 180
city: Bonn
country: Germany
facility: Research Site 178
city: Dresden
country: Germany
facility: Research Site 184
city: Hamburg
country: Germany
facility: Research Site 174
city: Heidelberg
country: Germany
facility: Research Site 182
city: Koeln
country: Germany
facility: Research Site 179
city: Leipzig
country: Germany
facility: Research Site 181
city: Mainz
country: Germany
facility: Research Site 173
city: Minden
country: Germany
facility: Research Site 176
city: Regensburg
country: Germany
facility: Research Site 171
city: Rostock
country: Germany
facility: Research Site 183
city: Tuebingen
country: Germany
facility: Research Site 175
city: Athens
country: Greece
facility: Research Site 194
city: Athens
country: Greece
facility: Research Site 196
city: Athens
country: Greece
facility: Research Site 197
city: Athens
country: Greece
facility: Research Site 201
city: Athens
country: Greece
facility: Research Site 202
city: Athens
country: Greece
facility: Research Site 205
city: Athens
country: Greece
facility: Research Site 207
city: Athens
country: Greece
facility: Reserach Site 206
city: Heraklion
country: Greece
facility: Research Site 198
city: Ioannina
country: Greece
facility: Research Site 204
city: Larissa
country: Greece
facility: Research Site 192
city: Marousi
country: Greece
facility: Research Site 199
city: Patras
country: Greece
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city: Patra
country: Greece
facility: Research Site 203
city: Thessaloniki
country: Greece
facility: Research Site 195
city: Ahmedabad
country: India
facility: Research Site 445
city: Bangalore
country: India
facility: Research Site 444
city: Mangalore
country: India
facility: Research Site 443
city: New Delhi
country: India
facility: Research Site 442
city: Bari
country: Italy
facility: Research Site 218
city: Catania
country: Italy
facility: Research Site 216
city: Cefalù
country: Italy
facility: Research Site 214
city: Firenze
country: Italy
facility: Research Site 219
city: Milano
country: Italy
facility: Research Site 221
city: Napoli
country: Italy
facility: Research Site 211
city: Napoli
country: Italy
facility: Research Site 215
city: Orbassano
country: Italy
facility: Research Site 220
city: Palermo
country: Italy
facility: Research Site 217
city: Pozzilli
country: Italy
facility: Research Site 212
city: Roma
country: Italy
facility: Research Site 213
city: Roma
country: Italy
facility: Research Site 222
city: Riga
country: Latvia
facility: Research Site 231
city: Riga
country: Latvia
facility: Research Site 232
city: Riga
country: Latvia
facility: Research Site 233
city: Kaunas
country: Lithuania
facility: Research site 241
city: Klaipeda
country: Lithuania
facility: Research site 244
city: Siauliai
country: Lithuania
facility: Research site 243
city: Vilnius
country: Lithuania
facility: Research site 242
city: Kuala Lumpur
country: Malaysia
facility: Research Site 551
city: Kuala Lumpur
country: Malaysia
facility: Research Site 554
city: Kuala Lumpur
country: Malaysia
facility: Research Site 556
city: Kuching
country: Malaysia
facility: Research Site 552
city: Seberang Jaya
country: Malaysia
facility: Research Site 553
city: Chisinau
country: Moldova, Republic of
facility: Research Site 251
city: Chisinau
country: Moldova, Republic of
facility: Research Site 252
city: Bergen
country: Norway
facility: Research Site 481
city: Drammen
country: Norway
facility: Research site 483
city: Namsos
country: Norway
facility: Research Site 482
city: Baguio City
country: Philippines
facility: Research Site 562
city: Cebu City
country: Philippines
facility: Research Site 561
city: Bydgoszcz
country: Poland
facility: Reserach Site 267
city: Bydgoszcz
country: Poland
facility: Reserach Site 268
city: Katowice-Ochojec
country: Poland
facility: Research site 274
city: Katowice
country: Poland
facility: Research Site 273
city: Katowice
country: Poland
facility: Research site 846
city: Krakow
country: Poland
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country: Poland
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city: Nowa Sol
country: Poland
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city: Poznan
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country: Poland
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country: Poland
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country: Poland
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city: Wroclaw
country: Poland
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city: Zabrze
country: Poland
facility: Research Site 261
city: Zamosc
country: Poland
facility: Research Site 278
city: Łódź
country: Poland
facility: Research Site 272
city: Aveiro
country: Portugal
facility: Research Site 293
city: Braga
country: Portugal
facility: Research Site 282
city: Coimbra
country: Portugal
facility: Research Site 289
city: Lisboa
country: Portugal
facility: Research Site 281
city: Lisboa
country: Portugal
facility: Research Site 283
city: Lisboa
country: Portugal
facility: Research Site 287
city: Matosinhos
country: Portugal
facility: Research SIte 284
city: Porto
country: Portugal
facility: Research Site 292
city: Pragal
country: Portugal
facility: Research Site 288
city: Santa Maria da Feira
country: Portugal
facility: Research Site 291
city: Torres Vedras
country: Portugal
facility: Research Site 286
city: Guaynabo
country: Puerto Rico
facility: Research Site 791
city: Brasov
country: Romania
facility: Research Site 314
city: București
country: Romania
facility: Research Site 307
city: Caracal
country: Romania
facility: Research Site 309
city: Targu Mures
country: Romania
facility: Research Site 302
city: Kazan
country: Russian Federation
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city: Kazan
country: Russian Federation
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city: Kemerovo
country: Russian Federation
facility: Research Site 323
city: Kirov
country: Russian Federation
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country: Russian Federation
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city: Krasnoyarsk
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country: Russian Federation
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city: Moscow
country: Russian Federation
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city: Moscow
country: Russian Federation
facility: Research Site 345
city: Nizhniy Novgorod
country: Russian Federation
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city: Novosibirsk
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city: Novosibirsk
country: Russian Federation
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city: Novosibirsk
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city: Novosibirsk
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country: Russian Federation
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city: Saint-Petersburg
country: Russian Federation
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city: Saint-Petersburg
country: Russian Federation
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city: Saint-Petersburg
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country: Russian Federation
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country: South Africa
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city: Cape Town
country: South Africa
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city: Cape Town
country: South Africa
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country: Spain
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country: Spain
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country: Spain
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country: Spain
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country: Spain
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country: Spain
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country: Spain
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city: Valencia
country: Spain
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country: Spain
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country: Sweden
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country: Sweden
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country: Sweden
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city: Aarau
country: Switzerland
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country: Switzerland
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city: Lugano
country: Switzerland
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city: Bangkoknoi
country: Thailand
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city: Muang
country: Thailand
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city: Ankara
country: Turkey
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city: Ankara
country: Turkey
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country: Turkey
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city: Istanbul
country: Turkey
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country: Turkey
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city: Istanbul
country: Turkey
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country: Turkey
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country: Turkey
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country: Turkey
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country: Turkey
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city: Samsun
country: Turkey
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country: Turkey
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city: Chernihiv
country: Ukraine
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city: Chernihiv
country: Ukraine
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city: Dnipro
country: Ukraine
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city: Dnipro
country: Ukraine
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city: Dnipro
country: Ukraine
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city: Ivano-Frankivsk
country: Ukraine
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city: Kharkiv
country: Ukraine
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city: Kharkiv
country: Ukraine
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city: Kharkiv
country: Ukraine
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city: Kherson
country: Ukraine
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city: Kyiv
country: Ukraine
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city: Kyiv
country: Ukraine
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city: Lutsk
country: Ukraine
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city: Lviv
country: Ukraine
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city: Poltava
country: Ukraine
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city: Rivne
country: Ukraine
facility: Research Site 625
city: Ternopil
country: Ukraine
facility: Research Site 628
city: Uzhgorod
country: Ukraine
facility: Research Site 630
city: Vinnytsia
country: Ukraine
facility: Research Site 623
city: Zaporizhzhia
country: Ukraine
facility: Research Site 412
city: Zaporizhzhia
country: Ukraine
facility: Research Site 621
city: Zaporizhzhia
country: Ukraine
facility: Research Site 631
city: Zhytomyr
country: Ukraine
facility: Research Site 626
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: Montalban X, Vermersch P, Arnold DL, Bar-Or A, Cree BAC, Cross AH, Kubala Havrdova E, Kappos L, Stuve O, Wiendl H, Wolinsky JS, Dahlke F, Le Bolay C, Shen Loo L, Gopalakrishnan S, Hyvert Y, Javor A, Guehring H, Tenenbaum N, Tomic D; evolutionRMS investigators. Safety and efficacy of evobrutinib in relapsing multiple sclerosis (evolutionRMS1 and evolutionRMS2): two multicentre, randomised, double-blind, active-controlled, phase 3 trials. Lancet Neurol. 2024 Nov;23(11):1119-1132. doi: 10.1016/S1474-4422(24)00328-4. Epub 2024 Sep 19.