Phase
Condition
Multiple Sclerosis
Memory Loss
Neurologic Disorders
Treatment
Diroximel fumarate
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Must have a diagnosis of RMS, as defined by revised 2017 McDonald's criteria.
Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0, inclusive, atscreening and baseline visit (Day 1).
Neurologically stable with no evidence of relapse within 30 days prior to baselinevisit (Day 1).
For Japanese participants: Born in Japan and biological parents and grandparentswere of Japanese origin. If previously lived outside of Japan for more than 5 years,must not have had a significantly modified diet since leaving Japan.
For Chinese participants: Born in China, and biological parents and grandparentswere of Chinese origin. If previously lived outside of China for more than 5 years,must not have had a significantly modified diet since leaving China.
Exclusion
Key Exclusion Criteria:
Has a multiple sclerosis (MS) relapse that has occurred within the 30 days prior torandomization and/or the participant has not stabilized from a previous relapseprior to randomization.
History of severe allergic or anaphylactic reactions or of any allergic reactionsthat, in the opinion of the investigator, are likely to be exacerbated by anycomponent of the study treatment.
History of, or ongoing, malignant disease, including solid tumors and hematologicmalignancies.
Has a history of gastrointestinal (GI) surgery (except appendectomy orcholecystectomy that occurred more than 6 months prior to screening), irritablebowel syndrome, inflammatory bowel disease (Crohn's disease, ulcerative colitis), orother clinically significant and active GI condition per the investigator'sdiscretion.
History of clinically significant recurring or active GI symptoms (e.g., nausea,diarrhea, dyspepsia, constipation) within 90 days of screening, including symptomsthat require the initiation of symptomatic medical treatment (e.g., initiation of amedication to treat gastroesophageal reflux disease) or a change in symptomaticmedical treatment (e.g., an increase in dose) within 90 days prior to screening.
History of systemic hypersensitivity reaction to DRF, dimethyl fumarate (DMF), MMFor other fumaric esters, the excipients contained in the formulation, and ifappropriate, any diagnostic agents to be administered during the study.
Evidence of current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)infection within 14 days prior to Screening, between screening and baseline visit (Day 1), or at baseline visit (Day 1), including but not limited to a fever (temperature >37.5 degrees Celsius [°C]), new and persistent cough, breathlessness,or loss of taste and/or smell. Evidence of current SARS-CoV-2 infection within 14days prior to Screening or during Screening, will be eligible for rescreening,provided that the participant is asymptomatic for 14 days prior to rescreening.
Have close contact within 14 days prior to Day 1 with individual(s) with suspectedSARS-CoV-2 infection.
For participants who had close contact with individual(s) with suspected SARS-CoV-2infection within 14 days prior to Day 1, as determined by the Investigator, will beeligible for rescreening, provided that the participant is asymptomatic for 14 daysafter the contact.
History or positive test result at screening for human immunodeficiency virus (HIV).
Previous participation in this study or previous studies with DRF, DMF, or MMF.
Has a clinically significant history of suicidal ideation or suicidal behavioroccurring in the past 12 months as assessed by the C-SSRS at Screening.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui 230022
ChinaSite Not Available
Beijing Hospital
Beijing, Beijing 100006
ChinaSite Not Available
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing 100050
ChinaSite Not Available
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
ChinaSite Not Available
Lanzhou University Second Hospital
Lanzhou, Gansu 730030
ChinaSite Not Available
Dongguan People's Hospital
Dongguan, Guangdong 523059
ChinaSite Not Available
Guangzhou First People's Hospital
Guangzhou, Guangdong 510180
ChinaSite Not Available
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong 510515
ChinaSite Not Available
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong 510080
ChinaSite Not Available
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong 510260
ChinaSite Not Available
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510630
ChinaSite Not Available
Tangshan Gongren Hospital
Tangshan, Hebei 063003
ChinaSite Not Available
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang 150040
ChinaSite Not Available
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang 150086
ChinaSite Not Available
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei 430030
ChinaSite Not Available
Xiangya Hospital, Central South University
Changsha, Hunan 410008
ChinaSite Not Available
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia 10050
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215004
ChinaSite Not Available
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi 330006
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330006
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, Jilin 130021
ChinaSite Not Available
Shengjing Hospital of China Medical University
Shengyang, Liaoning 110004
ChinaSite Not Available
General Hospital of Ningxia Medical University
Yinchuan, Ningxia 750004
ChinaSite Not Available
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
Shanghai, Shanghai 200001
ChinaSite Not Available
Shanxi Provincial People's Hospital
Taiyuan, Shanxi 30012
ChinaSite Not Available
Tangdu Hospital, Fourth Military Medical University
Xi'an, Shanxi 710038
ChinaSite Not Available
Sichuan Provincial People's Hospital
Chengdu, Sichuan 610072
ChinaSite Not Available
Tianjin Medical University Affiliated General Hospital
Tianjin, Tianjin 300052
ChinaSite Not Available
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan 650032
ChinaSite Not Available
Research Site
Tianjin, 300052
ChinaActive - Recruiting
Chiba University Hospital
Chiba-shi, Chiba-Ken 260-8677
JapanSite Not Available
Tokyo Womens Medical University Yachiyo Medical Center
Yachiyo-City, Chiba-Ken 276-8524
JapanSite Not Available
Ehime University Hospital
Toon-shi, Ehime-Ken 791-0295
JapanSite Not Available
Fukuoka University Hospital
Fukuoka-shi, Fukuoka-Ken 814-0180
JapanSite Not Available
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, Fukuoka-Ken 807-8556
JapanSite Not Available
Southern Tohoku Medical Clinic
Koriyama-shi, Fukushima-Ken 963-8563
JapanSite Not Available
NHO Asahikawa Medical Center
Asahikawa-shi, Hokkaido 070-8644
JapanSite Not Available
Obihiro Kosei Hospital
Obihiro-City, Hokkaido 080-0024
JapanSite Not Available
NHO Hokkaido Medical Center
Sapporo-shi, Hokkaido 063-0005
JapanSite Not Available
University of Tsukuba Hospital
Tsukuba-shi, Ibaraki-Ken 305-8576
JapanSite Not Available
Iwate Medical University Uchimaru Medical Center
Morioka-shi, Iwate-Ken 020-8505
JapanSite Not Available
Yokohama City University Hospital
Yokohama-shi, Kanagawa-Ken 236-0004
JapanSite Not Available
Tohoku Medical and Pharmaceutical University Hospital
Sendai City, Miyagi-Ken 983-8512
JapanSite Not Available
Tohoku University Hospital
Sendai City, Miyagi-Ken 980-8574
JapanSite Not Available
Niigata University Medical & Dental Hospital
Niigata-shi, Niigata-Ken 951-8520
JapanSite Not Available
Kansai Medical University Medical Center
Moriguchi-shi, Osaka-Fu 570-8507
JapanSite Not Available
Saitama Medical Center
Kawagoe-shi, Saitama-Ken 350-8550
JapanSite Not Available
Juntendo University Hospital
Bunkyo-ku, Tokyo-To 113-8431
JapanSite Not Available
National Center of Neurology and Psychiatry
Kodaira-shi, Tokyo-To 187-8551
JapanSite Not Available
Ebara Hospital
Ota-ku, Tokyo-To 145-0065
JapanSite Not Available
Department of Neurosurgery, Tokyo Women's Medical University
Shinjuku-ku, Tokyo-To 162-8666
JapanSite Not Available
Wakayama Medical University Hospital
Wakayama-shi, Wakayama-Ken 641-8510
JapanSite Not Available
Yamaguchi University Hospital
Ube-shi, Yamaguchi-Ken 755-8505
JapanSite Not Available
Research Site
Asahikawa-shi, 070-8644
JapanActive - Recruiting
Research Site
Bunkyo-ku, 113-8431
JapanActive - Recruiting
Research Site
Chiba-City, 260-8677
JapanSite Not Available
Research Site
Fukuoka-shi, 814-0180
JapanActive - Recruiting
Research Site
Kawagoe-shi, 350-8550
JapanActive - Recruiting
Research Site
Kitakyushu-shi, 807-8555
JapanActive - Recruiting
Research Site
Kodaira, 187-8551
JapanSite Not Available
Research Site
Koriyama-shi, 963-8052
JapanActive - Recruiting
Research Site
Moriguchi-shi, 570-8507
JapanActive - Recruiting
Research Site
Morioka-shi, 020-8505
JapanActive - Recruiting
Research Site
Niigata-shi, 951-8510
JapanActive - Recruiting
Research Site
Obihiro-City, 080-0024
JapanActive - Recruiting
Research Site
Ota-ku, 145-0065
JapanActive - Recruiting
Research Site
Sapporo-shi, 063-0005
JapanActive - Recruiting
Research Site
Sendai City, 980-8574
JapanActive - Recruiting
Research Site
Shinjukuku, 162-8666
JapanSite Not Available
Research Site
Toon, 791-0295
JapanSite Not Available
Research Site
Tsukuba-shi, 305-8576
JapanActive - Recruiting
Research Site
Ube City, 755-8505
JapanSite Not Available
Research Site
Wakayama City, 641-8510
JapanSite Not Available
Research Site
Yachiyo-City, 276-8524
JapanActive - Recruiting
Research Site
Yokohama-shi, 236-0004
JapanActive - Recruiting
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