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The objective of this study is to evaluate the safety and efficacy of ONO-4641 in patients with relapsing-remitting multiple sclerosis over a 26-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E1 | Experimental |
| |
| E2 | Experimental |
| |
| E3 | Experimental |
| |
| P | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-4641 | Drug | 0.15 mg once per day for 26 weeks |
| |
| ONO-4641 |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of T-1-weighted Gd-enhanced lesions obtained with MRI at 4-week intervals for 26 weeks. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total volume of Gd-enhanced lesions | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ono Pharma USA, Inc. | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Clinical Site 133 | Tucson | Arizona | 85741 | United States | ||
| Aurora Clinical Site 132 |
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| Drug |
0.1 mg once per day for 26 weeks |
|
| ONO-4641 | Drug | 0.05 mg once per day for 26 weeks |
|
| ONO-4641 placebo | Drug | Placebo once per day for 26 weeks |
|
| Aurora |
| Colorado |
| 80045 |
| United States |
| Fort Collins Clinical Site 123 | Fort Collins | Colorado | 80528 | United States |
| Fairfield Clinical Site 110 | Fairfield | Connecticut | 06824 | United States |
| Ormond Beach Clinical Site 129 | Ormond Beach | Florida | 32174 | United States |
| Sarasota Clinical Site 116 | Sarasota | Florida | 34243 | United States |
| Sarasota Clinical Site 117 | Sarasota | Florida | 34243 | United States |
| Northbrook Clinical Site 135 | Northbrook | Illinois | 60062 | United States |
| Fort Wayne Clinical Site 111 | Fort Wayne | Indiana | 46805 | United States |
| Indianapolis Clinical Site 121 | Indianapolis | Indiana | 46202 | United States |
| Detroit Clinical Site 104 | Detroit | Michigan | 48202 | United States |
| Farmington Hills Clinical Site 126 | Farmington Hills | Michigan | 48334 | United States |
| Lebanon Clinical Site 115 | Lebanon | New Hampshire | 03756 | United States |
| Albuquerque Clinical Site 106 | Albuquerque | New Mexico | 87131 | United States |
| Rochester Clinical Site 108 | Rochester | New York | 14642 | United States |
| Charlotte Clinical Site 125 | Charlotte | North Carolina | 28204 | United States |
| HighPoint Clinical Site 128 | HighPoint | North Carolina | 27265 | United States |
| Raleigh Clinical Site 103 | Raleigh | North Carolina | 27607 | United States |
| Akron Clinical Site 112 | Akron | Ohio | 44320 | United States |
| Philadelphia Clinical Site 120 | Philadelphia | Pennsylvania | 19104 | United States |
| Knoxville Clinical Site 134 | Knoxville | Tennessee | 37934 | United States |
| Round Rock Clinical Site 107 | Round Rock | Texas | 78681 | United States |
| Seattle Clinical Site 118 | Seattle | Washington | 98101 | United States |
| Brugge Clinical Site 203 | Bruges | 8000 | Belgium |
| La Louviere Clinical Site 201 | La Louvière | 7100 | Belgium |
| Sijsele Clinical Site 202 | Sijsele | 8340 | Belgium |
| Gatineau Clinical Site 114 | Gatineau | Quebec | Canada |
| Greenfield Park Clinical Site 109 | Greenfield Park | Quebec | J4V2J2 | Canada |
| Vancouver Clinical Site 131 | British Columbia | V6T 2B5 | Canada |
| Montreal Clinical Site 113 | Québec | H1T 2M4 | Canada |
| Montreal Clinical Site 102 | Québec | H9X 3Z9 | Canada |
| Olomouc Clinical Site 212 | Olomouc | 775 20 | Czechia |
| Ostrava Clinical Site 214 | Ostrava | 702 00 | Czechia |
| Pardubice Clinical Site 211 | Pardubice | 532 03 | Czechia |
| Praha 5 Clinical Site 213 | Prague | 150 06 | Czechia |
| Berlin Clinical Site 223 | Berlin | 13347 | Germany |
| Essen Clinical Site 222 | Essen | 45147 | Germany |
| Giessen Clinical Site 221 | Giessen | 35385 | Germany |
| Leipzig Clinical Site 229 | Leipzig | 04103 | Germany |
| Mainz Clinical Site 231 | Mainz | 55101 | Germany |
| Marburg Clinical Site 228 | Marburg | 35033 | Germany |
| Munster Clinical Site 225 | Münster | 48149 | Germany |
| Tubingen Clinical Site 226 | Tübingen | 72076 | Germany |
| Ulm Clinical Site 230 | Ulm | 89081 | Germany |
| Athens Clinical Site 243 | Athens | 11529 | Greece |
| Thessaloniki Clinical Site 245 | Thessaloniki | 57010 | Greece |
| Kanto Region Clinical Site 404 | Kanto | Japan |
| Kanto Region Clinical Site 405 | Kanto | Japan |
| Kanto Region Clinical Site 406 | Kanto | Japan |
| Kanto Region Clinical Site 409 | Kanto | Japan |
| Kinki Region Clinical Site 401 | Kinki | Japan |
| Kinki Region Clinical Site 407 | Kinki | Japan |
| Kinki Region Clinical Site 408 | Kinki | Japan |
| Tohoku Region Clinical Site 403 | Tōhoku | Japan |
| Tohoku Region Clinical Site 410 | Tōhoku | Japan |
| Bialystok Clinical Site 305 | Bialystok | 15-402 | Poland |
| Czeladz Clinical Site 303 | Czeladź | 41-250 | Poland |
| Gdansk Clinical Site 302 | Gdansk | 80-803 | Poland |
| Katowice Clinical Site 309 | Katowice | 40-594 | Poland |
| Krakow Clinical Site 307 | Krakow | 31-530 | Poland |
| Lodz Clinical Site 306 | Lodz | 90-153 | Poland |
| Plewiska Clinical Site 304 | Plewiska | 62-064 | Poland |
| Warszawa Clinical Site 308 | Warsaw | 04-749 | Poland |
| Chelyabinsk Clinical Site 322 | Chelyabinsk | 454136 | Russia |
| Kaluga Clinical Site 328 | Kaluga | 428007 | Russia |
| Kazan Clinical Site 333 | Kazan' | 420103 | Russia |
| Moscow Clinical Site 332 | Moscow | 107150 | Russia |
| Nizhniy Novgorod Clinical Site 321 | Nizhny Novgorod | 603155 | Russia |
| Novosibirsk Clinical Site 324 | Novosibirsk | 630091 | Russia |
| St. Petersburg Clinical Site 325 | Saint Petersburg | 428007 | Russia |
| St. Petersburg Clinical Site 327 | Saint Petersburg | 428007 | Russia |
| Samara Clinical Site 328 | Samara | 443095 | Russia |
| Ufa Clinical Site 326 | Ufa | 450005 | Russia |
| Yaroslavl Clinical Site 331 | Yaroslavl | 150030 | Russia |
| Barcelona Clinical Site 252 | Barcelona | 08025 | Spain |
| Barcelona Clinical Site 253 | Barcelona | 08025 | Spain |
| Bilbao Clinical Site 255 | Bilbao | 48013 | Spain |
| Girona Clinical Site 254 | Girona | 17007 | Spain |
| Hospitalet de Llobregat Clinical Site 251 | L'Hospitalet de Llobregat | 08907 | Spain |
| Sevilla Clinical Site 256 | Seville | 41071 | Spain |
| Dnipropetrovsk Clinical Site 341 | Dnipropetrovsk | 49027 | Ukraine |
| Donetsk Clinical Site 345 | Donetsk | 83000-490 | Ukraine |
| Kharkiv Clinical Site 346 | Kharkiv | 61068 | Ukraine |
| Kyiv Clinical Site 344 | Kyiv | 03110 | Ukraine |
| Lviv Clinical Site 343 | Lviv | 79010 | Ukraine |
| Vinnytsya Clinical Site 342 | Vinnytsia | 21005 | Ukraine |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000606993 | ceralifimod |
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