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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05083923
Other study ID # 272MS303
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 18, 2021
Est. completion date July 15, 2024

Study information

Verified date October 2023
Source Biogen
Contact US Biogen Clinical Trial Center
Phone 866-633-4636
Email clinicaltrials@biogen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objectives of this study are to determine the safety and tolerability of DRF administered for up to 24 weeks in adult East Asian participants with RMS (Part 1) and to determine the safety and tolerability of DRF administered for up to 48 weeks in adult East Asian participants with RMS (Part 2). The secondary objective of this study is to evaluate the pharmacokinetic(s) (PK) of DRF metabolites (monomethyl fumarate [MMF] and 2-hydroxyethyl succinimide [HES]) following multiple doses of DRF in a subset of adult East Asian participants with RMS (Part 1).


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 15, 2024
Est. primary completion date July 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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, at screening and baseline visit (Day 1). - Neurologically stable with no evidence of relapse within 30 days prior to baseline visit (Day 1). - For Japanese participants: Born in Japan and biological parents and grandparents were 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 grandparents were 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. Key Exclusion Criteria: - Has a multiple sclerosis (MS) relapse that has occurred within the 30 days prior to randomization and/or the participant has not stabilized from a previous relapse prior to randomization. - History of severe allergic or anaphylactic reactions or of any allergic reactions that, in the opinion of the investigator, are likely to be exacerbated by any component of the study treatment. - History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies. - Has a history of gastrointestinal (GI) surgery (except appendectomy or cholecystectomy that occurred more than 6 months prior to screening), irritable bowel syndrome, inflammatory bowel disease (Crohn's disease, ulcerative colitis), or other clinically significant and active GI condition per the investigator's discretion. - History of clinically significant recurring or active GI symptoms (e.g., nausea, diarrhea, dyspepsia, constipation) within 90 days of screening, including symptoms that require the initiation of symptomatic medical treatment (e.g., initiation of a medication to treat gastroesophageal reflux disease) or a change in symptomatic medical treatment (e.g., an increase in dose) within 90 days prior to screening. - History of systemic hypersensitivity reaction to DRF, dimethyl fumarate (DMF), MMF or other fumaric esters, the excipients contained in the formulation, and if appropriate, 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 14 days 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 suspected SARS-CoV-2 infection. - For participants who had close contact with individual(s) with suspected SARS-CoV-2 infection within 14 days prior to Day 1, as determined by the Investigator, will be eligible for rescreening, provided that the participant is asymptomatic for 14 days after 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 behavior occurring in the past 12 months as assessed by the C-SSRS at Screening. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Diroximel fumarate
Administered as specified in the treatment arm

Locations

Country Name City State
China Beijing Hospital Beijing Beijing
China Beijing Tiantan Hospital, Capital Medical University Beijing Beijing
China The First Hospital of Jilin University Changchun Jilin
China Xiangya Hospital, Central South University Changsha Hunan
China Sichuan Provincial People's Hospital Chengdu Sichuan
China Dongguan People's Hospital Dongguan Guangdong
China Fujian Medical University Union Hospital Fuzhou Fujian
China Guangzhou First People's Hospital Guangzhou Guangdong
China Nanfang Hospital of Southern Medical University Guangzhou Guangdong
China The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong
China The Second Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong
China The Third Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong
China The First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang
China The Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang
China The First Affiliated Hospital of Anhui Medical University Hefei Anhui
China The Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia
China First Affiliated Hospital of Kunming Medical University Kunming Yunnan
China Lanzhou University Second Hospital Lanzhou Gansu
China Jiangxi Provincial People's Hospital Nanchang Jiangxi
China The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
China Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch Shanghai Shanghai
China Shengjing Hospital of China Medical University Shengyang Liaoning
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu
China Shanxi Provincial People's Hospital Taiyuan Shanxi
China Tangshan Gongren Hospital Tangshan Hebei
China Tianjin Medical University Affiliated General Hospital Tianjin Tianjin
China Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology Wuhan Hubei
China Tangdu Hospital, Fourth Military Medical University Xi'an Shanxi
China General Hospital of Ningxia Medical University Yinchuan Ningxia
Japan NHO Asahikawa Medical Center Asahikawa-shi Hokkaido
Japan Juntendo University Hospital Bunkyo-ku Tokyo-To
Japan Chiba University Hospital Chiba-shi Chiba-Ken
Japan Fukuoka University Hospital Fukuoka-shi Fukuoka-Ken
Japan Saitama Medical Center Kawagoe-shi Saitama-Ken
Japan Hospital of the University of Occupational and Environmental Health Kitakyushu-shi Fukuoka-Ken
Japan National Center of Neurology and Psychiatry Kodaira-shi Tokyo-To
Japan Southern Tohoku Medical Clinic Koriyama-shi Fukushima-Ken
Japan Kansai Medical University Medical Center Moriguchi-shi Osaka-Fu
Japan Iwate Medical University Uchimaru Medical Center Morioka-shi Iwate-Ken
Japan Niigata University Medical & Dental Hospital Niigata-shi Niigata-Ken
Japan Obihiro Kosei Hospital Obihiro-City Hokkaido
Japan Ebara Hospital Ota-ku Tokyo-To
Japan NHO Hokkaido Medical Center Sapporo-shi Hokkaido
Japan Tohoku Medical and Pharmaceutical University Hospital Sendai City Miyagi-Ken
Japan Tohoku University Hospital Sendai City Miyagi-Ken
Japan Department of Neurosurgery, Tokyo Women's Medical University Shinjuku-ku Tokyo-To
Japan Ehime University Hospital Toon-shi Ehime-Ken
Japan University of Tsukuba Hospital Tsukuba-shi Ibaraki-Ken
Japan Yamaguchi University Hospital Ube-shi Yamaguchi-Ken
Japan Wakayama Medical University Hospital Wakayama-shi Wakayama-Ken
Japan Tokyo Womens Medical University Yachiyo Medical Center Yachiyo-City Chiba-Ken
Japan Yokohama City University Hospital Yokohama-shi Kanagawa-Ken

Sponsors (1)

Lead Sponsor Collaborator
Biogen

Countries where clinical trial is conducted

China,  Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event. Week 24
Primary Part 1: Number of Participants with Potentially Clinically Serious (PCS) Change from Baseline in Clinical Laboratory Parameters Clinical laboratory parameters will include chemistry, hematology and urinalysis parameters. Baseline (Day 1) to Week 24
Primary Part 1: Number of Participants with PCS Change from Baseline in 12-Lead Electrocardiogram (ECG) Parameters Baseline (Day 1) to Week 24
Primary Part 1: Number of Participants with PCS Change from Baseline in Vital Sign Parameters Vital sign parameters will include temperature, pulse rate, systolic and diastolic blood pressure, and respiratory rate. Baseline (Day 1) to Week 24
Primary Part 1: Number of Participants with Columbia Suicide Severity Rating Scale (C-SSRS) Events The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assesses whether participant experiences any of the following 1. completed suicide, 2. suicide attempt (response of "yes" on "actual attempt"), 3. preparatory acts toward imminent suicidal behavior ("yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), 4. any suicidal behavior or ideation, suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent"), 5. self-injurious behavior, no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). Baseline (Day 1) to Week 24
Primary Part 2: Number of Participants with AEs and SAEs An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event. Up to Week 48
Primary Part 2: Number of Participants with PCS Change from Baseline in Clinical Laboratory Parameters Clinical laboratory parameters will include chemistry, hematology and urinalysis parameters. Baseline (Day 1) to Week 48
Primary Part 2: Number of Participants with PCS Change from Baseline in 12-Lead ECG Parameters Baseline (Day 1) to Week 48
Primary Part 2: Number of Participants with PCS Change from Baseline in Vital Sign Parameters Vital sign parameters will include temperature, pulse rate, systolic and diastolic blood pressure, and respiratory rate. Baseline (Day 1) to Week 48
Primary Part 2: Number of Participants with C-SSRS Events The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assesses whether participant experiences any of the following 1. completed suicide, 2. suicide attempt (response of "yes" on "actual attempt"), 3. preparatory acts toward imminent suicidal behavior ("yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), 4. any suicidal behavior or ideation, suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent"), 5. self-injurious behavior, no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). Baseline (Day 1) to Week 48
Secondary Part 1: Plasma Concentrations of MMF and HES Predose and at multiple timepoints postdose on Days 29, 57, 85, 113, 141 and 169
Secondary Part 1: Maximum Observed Concentration (Cmax) of MMF and HES Predose and at multiple timepoints postdose on Days 29, 57, 85, 113, 141 and 169
Secondary Part 1: Area Under the Concentration-Time Curve from Time Zero to Time of Last Measurable Concentration (AUClast) of MMF and HES Predose and at multiple timepoints postdose on Days 29, 57, 85, 113, 141 and 169
Secondary Part 1: Time to Reach Cmax (Tmax) of MMF and HES Predose and at multiple timepoints postdose on Days 29, 57, 85, 113, 141 and 169
Secondary Part 1: Elimination Half-Life (t½) of MMF Predose and at multiple timepoints postdose on Days 29, 57, 85, 113, 141 and 169
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