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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04338061
Other study ID # MS200527_0082
Secondary ID 2019-004980-36
Status Terminated
Phase Phase 3
First received
Last updated
Start date July 2, 2020
Est. completion date March 19, 2024

Study information

Verified date April 2024
Source Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 1124
Est. completion date March 19, 2024
Est. primary completion date October 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 <= 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.

Study Design


Intervention

Drug:
Evobrutinib
Evobrutinib twice daily (BID) in DBTP.
Placebo (match to Teriflunomide)
Placebo match to Teriflunomide once daily in DBTP.
Teriflunomide
Teriflunomide once daily in DBTP.
Placebo (match to Evobrutinib)
Placebo match to Evobrutinib BID in DBTP.

Locations

Country Name City State
Belarus Research Site 144 Gomel
Belarus Research Site 143 Grodno
Belarus Research Site 142 Minsk
Belarus Research Site 141 Vitebsk
Belarus Research Site 145 Vitebsk
Brazil Research Site 603 Belo Horizonte
Brazil Research Site 599 Curitiba
Brazil Research Site 604 Goiânia
Brazil Research Site 600 Joinville
Brazil Research Site 614 Passo Fundo
Brazil Research Site 591 Porto Alegre
Brazil Research Site 594 Porto Alegre
Brazil Research Site 596 Porto Alegre
Brazil Research Site 609 Vitória
Bulgaria Research Site 155 Blagoevgrad
Bulgaria Research Site 156 Dupnitsa
Bulgaria Research Site 157 Pleven
Bulgaria Research Site 801 Pleven
Bulgaria Research Site 804 Pleven
Bulgaria Research Site 805 Plovdiv
Bulgaria Research Site 151 Sofia
Bulgaria Research Site 152 Sofia
Bulgaria Research Site 153 Sofia
Bulgaria Research Site 158 Sofia
Bulgaria Research Site 159 Sofia
Bulgaria Research Site 160 Sofia
Bulgaria Research Site 802 Sofia
Bulgaria Research Site 803 Sofia
Bulgaria Research Site 808 Sofia
Bulgaria Research Site 154 Veliko Tarnovo
Canada Research Site 106 Burnaby
Canada Research Site 107 London
Canada Research Site 105 Montreal
Canada Research Site 101 Ottawa
France Research Site 455 Bordeaux Cedex
France Research Site 459 Brest cedex 2
France Reserach Site 451 Clermont Ferrand Cedex
France Research Site 458 Limoges cedex
France Research Site 456 Nimes
France Research Site 453 Paris
France Research Site 457 Pringy cedex
France Research Site 452 Strasbourg cedex
France Research Site 454 Tours cedex 9
Germany Research Site 172 Augsburg
Germany Research Site 177 Berlin
Germany Research Site 180 Berlin
Germany Research Site 178 Bonn
Germany Research Site 184 Dresden
Germany Research Site 174 Hamburg
Germany Research Site 182 Heidelberg
Germany Research Site 179 Koeln
Germany Research Site 181 Leipzig
Germany Research Site 173 Mainz
Germany Research Site 176 Minden
Germany Research Site 171 Regensburg
Germany Research Site 183 Rostock
Germany Research Site 175 Tuebingen
Greece Research Site 194 Athens
Greece Research Site 196 Athens
Greece Research Site 197 Athens
Greece Research Site 201 Athens
Greece Research Site 202 Athens
Greece Research Site 205 Athens
Greece Research Site 207 Athens
Greece Reserach Site 206 Athens
Greece Research Site 198 Heraklion
Greece Research Site 204 Ioannina
Greece Research Site 192 Larissa
Greece Research Site 199 Marousi
Greece Research Site 203 Patra
Greece Research Site 191 Patras
Greece Research Site 195 Thessaloniki
India Research Site 445 Ahmedabad
India Research Site 444 Bangalore
India Research Site 443 Mangalore
India Research Site 442 New Delhi
Italy Research Site 218 Bari
Italy Research Site 216 Catania
Italy Research Site 214 Cefalù
Italy Research Site 219 Firenze
Italy Research Site 221 Milano
Italy Research Site 211 Napoli
Italy Research Site 215 Napoli
Italy Research Site 220 Orbassano
Italy Research Site 217 Palermo
Italy Research Site 212 Pozzilli
Italy Research Site 213 Roma
Italy Research Site 222 Roma
Latvia Research Site 231 Riga
Latvia Research Site 232 Riga
Latvia Research Site 233 Riga
Lithuania Research site 241 Kaunas
Lithuania Research site 244 Klaipeda
Lithuania Research site 243 Siauliai
Lithuania Research site 242 Vilnius
Malaysia Research Site 551 Kuala Lumpur
Malaysia Research Site 554 Kuala Lumpur
Malaysia Research Site 556 Kuala Lumpur
Malaysia Research Site 552 Kuching
Malaysia Research Site 553 Seberang Jaya
Moldova, Republic of Research Site 251 Chisinau
Moldova, Republic of Research Site 252 Chisinau
Norway Research Site 481 Bergen
Norway Research site 483 Drammen
Norway Research Site 482 Namsos
Philippines Research Site 562 Baguio City
Philippines Research Site 561 Cebu City
Poland Reserach Site 267 Bydgoszcz
Poland Reserach Site 268 Bydgoszcz
Poland Research Site 273 Katowice
Poland Research site 846 Katowice
Poland Research site 274 Katowice-Ochojec
Poland Research Site 276 Krakow
Poland Research Site 263 Lodz
Poland Research Site 272 Lódz
Poland Research Site 266 Nowa Sol
Poland Research Site 270 Poznan
Poland Research Site 262 Rzeszow
Poland Research Site 265 Siemianowice
Poland Research Site 271 Szczecin
Poland Research Site 264 Warszawa
Poland Research Site 277 Warszawa
Poland Reserach Site 275 Warszawa
Poland Research Site 261 Zabrze
Poland Research Site 278 Zamosc
Portugal Research Site 293 Aveiro
Portugal Research Site 282 Braga
Portugal Research Site 289 Coimbra
Portugal Research Site 281 Lisboa
Portugal Research Site 283 Lisboa
Portugal Research Site 287 Lisboa
Portugal Research SIte 284 Matosinhos
Portugal Research Site 292 Porto
Portugal Research Site 288 Pragal
Portugal Research Site 291 Santa Maria da Feira
Portugal Research Site 286 Torres Vedras
Puerto Rico Research Site 791 Guaynabo
Romania Research Site 314 Brasov
Romania Research Site 307 Bucure?ti
Romania Research Site 309 Caracal
Romania Research Site 302 Targu Mures
Russian Federation Research Site 325 Kazan
Russian Federation Research Site 329 Kazan
Russian Federation Research Site 323 Kemerovo
Russian Federation Research Site 344 Kirov
Russian Federation Research Site 340 Krasnodar
Russian Federation Research Site 334 Krasnoyarsk
Russian Federation Research Site 341 Moscow
Russian Federation Research Site 343 Moscow
Russian Federation Research Site 345 Moscow
Russian Federation Research Site 332 Nizhniy Novgorod
Russian Federation Research Site 327 Novosibirsk
Russian Federation Research Site 330 Novosibirsk
Russian Federation Research Site 331 Novosibirsk
Russian Federation Research Site 335 Novosibirsk
Russian Federation Research Site 328 Rostov-on-Don
Russian Federation Research Site 346 Saint Petersburg
Russian Federation Research Site 324 Saint-Petersburg
Russian Federation Research Site 338 Saint-Petersburg
Russian Federation Research Site 339 Saint-Petersburg
Russian Federation Research Site 342 Saint-Petersburg
Russian Federation Research Site 326 Saransk
Russian Federation Research Site 321 Sestroretsk
Russian Federation Research Site 337 Tyumen
Saudi Arabia Research Site 493 Riyadh
Singapore Research Site 571 Singapore
Singapore Research site 572 Singapore
Slovakia Research Site 351 Banska Bystrica
Slovakia Research Site 352 Bratislava
Slovakia Research Site 353 Bratislava
Slovakia Research Site 354 Bratislava
Slovakia Research Site 356 Bratislava
Slovakia Research Site 359 Dubnica nad Vahom
Slovakia Research Site 358 Trencin
Slovakia Research Site 357 Trnava
Slovenia Research Site 373 Celje
Slovenia Research Site 372 Ljubljana
Slovenia Research Site 371 Maribor
South Africa Research Site 501 Cape Town
South Africa Research Site 502 Cape Town
South Africa Research Site 503 Cape Town
South Africa Research Site 504 Pretoria
Spain Research Site 384 Alcorcon
Spain Research Site 391 Barakaldo
Spain Research Site 390 Barcelona
Spain Research Site 382 Cordoba
Spain Research Site 389 El Palmar
Spain Research Site 388 Madrid
Spain Research Site 392 Majadahonda
Spain Research Site 383 Malaga
Spain Research Site 387 Sevilla
Spain Research Site 385 Valencia
Spain Research Site 386 Valencia
Spain Research Site 381 Vigo
Sweden Research Site 512 Göteborg
Sweden Research site 514 Malmö
Sweden Research Site 511 Stockholm
Sweden Research Site 513 Uppsala
Switzerland Research Site 404 Aarau
Switzerland Research Site 402 Bern
Switzerland Research Site 403 Lugano
Thailand Research Site 583 Bangkoknoi
Thailand Research Site 582 Muang
Turkey Research Site 538 Ankara
Turkey Research Site 544 Ankara
Turkey Research Site 531 Istanbul
Turkey Research Site 534 Istanbul
Turkey Research Site 536 Istanbul
Turkey Research Site 541 Istanbul
Turkey Research Site 543 Istanbul
Turkey Research Site 539 Izmir
Turkey Research Site 533 Kocaeli
Turkey Research Site 537 Konya
Turkey Research Site 540 Mersin
Turkey Research Site 535 Samsun
Turkey Research Site 532 Trabzon
Ukraine Research Site 415 Chernihiv
Ukraine Research Site 417 Chernihiv
Ukraine Research Site 414 Dnipro
Ukraine Research Site 416 Dnipro
Ukraine Research Site 420 Dnipro
Ukraine Research Site 413 Ivano-Frankivsk
Ukraine Research Site 624 Kharkiv
Ukraine Research Site 632 Kharkiv
Ukraine Research Site 633 Kharkiv
Ukraine Research Site 419 Kherson
Ukraine Research Site 411 Kyiv
Ukraine Research Site 418 Kyiv
Ukraine Research Site 629 Lutsk
Ukraine Research Site 627 Lviv
Ukraine Research Site 622 Poltava
Ukraine Research Site 625 Rivne
Ukraine Research Site 628 Ternopil
Ukraine Research Site 630 Uzhgorod
Ukraine Research Site 623 Vinnytsia
Ukraine Research Site 412 Zaporizhzhia
Ukraine Research Site 621 Zaporizhzhia
Ukraine Research Site 631 Zaporizhzhia
Ukraine Research Site 626 Zhytomyr
United States Research Site 746 Altamonte Springs Florida
United States Research Site 724 Amherst New York
United States Research Site 736 Asheville North Carolina
United States Research Site 711 Canton Ohio
United States Research Site 712 Chapel Hill North Carolina
United States Research Site 759 Colorado Springs Colorado
United States Research Site 757 Columbus Ohio
United States Research Site 752 Cullman Alabama
United States Research Site 734 Dayton Ohio
United States Research Site 738 Detroit Michigan
United States Research Site 715 Evanston Illinois
United States Research Site 725 Fort Collins Colorado
United States Research Site 714 Fort Wayne Indiana
United States Research Site 751 Hanford California
United States Research Site 742 Honolulu Hawaii
United States Research Site 718 Jacksonville Florida
United States Research Site 744 Lafayette Indiana
United States Research Site 702 Naples Florida
United States Research Site 735 Nicholasville Kentucky
United States Research Site 721 Norfolk Virginia
United States Research Site 740 Orlando Florida
United States Research Site 717 Overland Park Kansas
United States Research Site 748 Philadelphia Pennsylvania
United States Research Site 726 Port Charlotte Florida
United States Research Site 723 Saint Louis Missouri
United States Research Site 703 San Antonio Texas
United States Research Site 719 Sarasota Florida
United States Research Site 706 Scarborough Maine
United States Research Site 741 Scottsdale Arizona
United States Research Site 707 Tampa Florida
United States Research Site 743 Tampa Florida
United States Research Site 704 Tucson Arizona
United States Research Site 732 Vero Beach Florida
United States Research Site 705 Weeki Wachee Florida
United States Research Site 737 West Hollywood California
United States Research Site 753 West Palm Beach Florida
United States Research Site 728 Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany EMD Serono Research & Development Institute, Inc.

Countries where clinical trial is conducted

United States,  Belarus,  Brazil,  Bulgaria,  Canada,  France,  Germany,  Greece,  India,  Italy,  Latvia,  Lithuania,  Malaysia,  Moldova, Republic of,  Norway,  Philippines,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Saudi Arabia,  Singapore,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  Thailand,  Turkey,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary DBTP: Annualized Relapse Rate (ARR) The annualized relapse rates up to 156 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). Up to 156 weeks
Primary DBE Period: ARR The annualized relapse rates up to 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). Up to 96 weeks
Primary OLE Period: Number of Participants with Adverse Events and Serious Adverse Events (SAE)s Baseline OLE up to 96 weeks
Secondary DBTP: Time to First Occurrence of 12-Week Confirmed Disability Progression (CDP) as measured by Expanded Disability Status Scale (EDSS) Progression Up to 156 weeks
Secondary DBTP: Time to First Occurrence of 24-Week CDP as measured by EDSS Progression Up to 156 weeks
Secondary DBTP: Time to First Occurrence of 24-Week Confirmed Disability Improvement (CDI) as measured by EDSS Improvement Up to 156 weeks
Secondary DBTP: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Physical Function (PF) Short Form Score Baseline up to 96 weeks
Secondary DBTP: Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Fatigue Short Form Score Baseline up to 96 weeks
Secondary DBTP: Total Number of Gadolinium-Enhancing (Gd+) T1 Lesions Assessed by all Available Magnetic Resonance Imaging (MRI) Scans Up to Week 156
Secondary DBTP: Total Number of New or Enlarging T2 Lesions Assessed by the Last Available Magnetic Resonance Imaging (MRI) Scan Relative to Baseline MRI Scan Up to Week 156
Secondary DBTP: Neurofilament light chain (NfL) Serum Concentration At Week 12
Secondary DBTP: Number of Participants With Adverse Events (AEs) 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. Baseline up to 156 weeks
Secondary DBTP: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings Number of participants with clinically significant change from baseline in vital signs, laboratory parameters and electrocardiogram findings will be reported. Baseline up to 156 weeks
Secondary DBTP: Absolute Concentrations of Immunoglobulin (Ig) Levels Baseline up to 156 weeks
Secondary DBTP: Change From Baseline in Immunoglobulin (Ig) Levels Baseline up to 156 weeks
Secondary DBE Period: Time to First Occurrence of 12-Week CDP as measured by EDSS Progression Up to 96 weeks
Secondary DBE Period: Time to First Occurrence of 24-Week CDP as measured by EDSS Progression Up to 96 weeks
Secondary DBE Period: Time to First Occurrence of 24-Week CDI as measured by EDSS Improvement Up to 96 weeks
Secondary DBE Period: Change From Baseline in PROMIS MS PF Short Form Score Baseline up to 96 weeks
Secondary DBE Period: Change From Baseline in PROMIS MS Fatigue Short Form Score Baseline up to 96 weeks
Secondary DBE Period: Total Number of Gd+ T1 Lesions Assessed by all Available MRI Scans Up to Week 96
Secondary DBE Period: Total Number of New or Enlarging T2 Lesions Assessed on the Last Available MRI Scans Relative to Baseline MRI Scan Up to Week 96
Secondary DBE Period: Number of Participants With Adverse Events (AEs) 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. Baseline up to 96 weeks
Secondary DBE Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings Number of participants with clinically significant change from baseline in vital signs, laboratory parameters and electrocardiogram findings will be reported. Baseline up to 96 weeks
Secondary DBE Period: Absolute Concentrations of Immunoglobulin (Ig) Levels Baseline up to 96 weeks
Secondary DBE Period: Change From Baseline in Immunoglobulin (Ig) Levels Baseline up to 96 weeks
Secondary OLE Period: ARR based on protocol-defined qualified relapses Baseline OLE up to 96 weeks
Secondary OLE Period: Time to first occurrence of 24-week CDP as measured by EDSS Baseline OLE up to 96 weeks
Secondary OLE Period: Time to first occurrence of 24-week CDI as measured by EDSS Baseline OLE up to 96 weeks
Secondary OLE Period: Symbol Digital Modalities Test Over time Baseline OLE up to 96 weeks
Secondary OLE Period: PROMISnq PF (MS) 15a score change over time Baseline OLE up to 96 weeks
Secondary OLE Period: PROMIS Fatigue (MS) 8a Score Change Over Time Baseline OLE up to 96 weeks
Secondary OLE Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Electrocardiogram (ECG) and Laboratory Findings Baseline OLE up to 96 weeks
Secondary OLE: Total Number of New or Enlarging T2 Lesions Assessed on the Last Available Magnetic Resonance Imaging (MRI) Scans Baseline OLE up to 96 weeks
Secondary OLE: Change from Baseline in T2 lesion Volume Over Time Baseline OLE up to 96 weeks
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