A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2
A Phase 3 Study in Subjects With Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate
2 other identifiers
interventional
506
3 countries
67
Brief Summary
The objectives of this study are to evaluate the utility of two gastrointestinal (GI) symptom scales (Individual GI Symptom and Impact Scale {IGISIS} and Global GI Symptom and Impact Scale {GGISIS}) in assessing GI tolerability in adult subjects with RRMS after administration of ALKS 8700 or Dimethyl Fumarate (DMF) in Part A, to compare the GI tolerability of ALKS 8700 and DMF in adult subjects with RRMS using IGISIS and GGISIS in Part B, and to Evaluate the safety and tolerability of ALKS 8700 in adult subjects with RRMS in Parts A and B.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2017
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2017
CompletedFirst Submitted
Initial submission to the registry
March 16, 2017
CompletedFirst Posted
Study publicly available on registry
March 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2019
CompletedResults Posted
Study results publicly available
July 14, 2020
CompletedJuly 14, 2020
July 1, 2020
2.3 years
March 16, 2017
June 1, 2020
July 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Days With Any Individual Gastrointestinal Symptom and Impact Scale (IGISIS) Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B
IGISIS assessed the intensity of five individual GI symptoms: nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea. Participants rated the intensity of each individual symptom via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). IGISIS was completed by the participants using e-diaries.
End of treatment (up to Week 6) for both Parts A and B
Secondary Outcomes (8)
Number of Days With Any IGISIS Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Part B
End of treatment (up to Week 6) for Part B
Number of Days With Any IGISIS Individual Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B
End of treatment (up to Week 6) for both Parts A and B
Number of Days With Any IGISIS Individual Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B
End of treatment (up to Week 6) for both Parts A and B
Number of Days With a Global GI Symptom and Impact Scale (GGISIS) Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B
End of treatment (up to Week 6) for both Parts A and B
Number of Days With a GGISIS Symptom Intensity Score ≥2 Relative to Exposure Days in Parts A and B
End of treatment (up to Week 6) for both Parts A and B
- +3 more secondary outcomes
Study Arms (2)
ALKS 8700
EXPERIMENTALOral capsules, administered orally twice daily.
Dimethyl Fumarate
ACTIVE COMPARATOROral capsules, administered orally twice daily.
Interventions
Administered as specified in the treatment arm.
Eligibility Criteria
You may qualify if:
- Capable of understanding and complying with the protocol
- Has a confirmed diagnosis of RRMS
- Neurologically stable with no evidence of relapse within 30 days prior to randomization
- Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration, or is surgically sterile or post-menopausal
You may not qualify if:
- Have any finding(s) that would compromise the safety of the subject, affect the subject's ability to adhere to the protocol visit schedule or to fulfill visit requirements, or would make the subject unsuitable for participation in the study
- Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
- History of clinically significant cardiovascular, pulmonary, GI, dermatologic, psychiatric, neurologic (other than MS), endocrine, renal, and/or other major disease that would preclude participation in a clinical trial
- History of GI surgery (except appendectomy that occurred more than 6 months prior to screening
- History of clinically significant recurring or active gastrointestinal symptoms (eg, nausea, diarrhea, dyspepsia, constipation) within 3 months of screening
- Chronic use (7 days) of medical therapy to treat any GI symptoms within 1 month of screening Has a clinically significant medical condition or observed abnormality at screening
- History of a myocardial infarction, including a silent myocardial infarction or unstable angina
- History of clinically significant drug or alcohol abuse within the past year prior to screening
- Clinically significant history of suicidal ideation or suicidal behavior in the last 12 months
- Subject is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 30 days after any study drug administration
- Prior use of Dimethyl Fumarate (DMF)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
- Alkermes, Inc.collaborator
Study Sites (67)
Alkermes Investigational Site
Cullman, Alabama, 35058, United States
Alkermes Investigational Site
Phoenix, Arizona, 85004, United States
Alkermes Investigational Site
Tucson, Arizona, 85704, United States
Alkermes Investigational Site
Long Beach, California, 90806, United States
Alkermes Investigational Site
San Diego, California, 92103, United States
Alkermes Investigational Site
Basalt, Colorado, 81621, United States
Alkermes Investigational Site
Centennial, Colorado, 80112, United States
Alkermes Investigational Site
Denver, Colorado, 80209, United States
Alkermes Investigational Site
Middlebury, Connecticut, 06762, United States
Alkermes Investigational Site
Stamford, Connecticut, 06905, United States
Alkermes Investigational Site
Washington D.C., District of Columbia, 20007, United States
Alkermes Investigational Site
Atlantis, Florida, 33462, United States
Alkermes Investigational Site
Bradenton, Florida, 34209, United States
Alkermes Investigational Site
Maitland, Florida, 32751, United States
Alkermes Investigational Site
Naples, Florida, 34105, United States
Alkermes Investigational Site
Ormond Beach, Florida, 32174, United States
Alkermes Investigational Site
Sarasota, Florida, 34233, United States
Alkermes Investigational Site
Tampa, Florida, 33634, United States
Alkermes Investigational Site
Vero Beach, Florida, 32960, United States
Alkermes Investigational Site
Atlanta, Georgia, 30312, United States
Alkermes Investigational Site
Atlanta, Georgia, 30327, United States
Alkermes Investigational Site
Atlanta, Georgia, 30342, United States
Alkermes Investigational Site
Columbus, Georgia, 31904, United States
Alkermes Investigational Site
Evanston, Illinois, 60201, United States
Alkermes Investigational Site
Des Moines, Iowa, 50314, United States
Alkermes Investigational Site
Lenexa, Kansas, 66214, United States
Alkermes Investigational Site
Alexandria, Louisiana, 71301, United States
Alkermes Investigational Site
Detroit, Michigan, 48202, United States
Alkermes Investigational Site
Golden Valley, Minnesota, 55422, United States
Alkermes Investigational Site
St Louis, Missouri, 63104, United States
Alkermes Investigational Site
St Louis, Missouri, 63110, United States
Alkermes Investigational Site
St Louis, Missouri, 63131, United States
Alkermes Investigational Site
Albuquerque, New Mexico, 87106, United States
Alkermes Investigational Site
Patchogue, New York, 11772, United States
Alkermes Investigational Site
Stony Brook, New York, 11794, United States
Alkermes Investigational Site
Syracuse, New York, 13210, United States
Alkermes Investigational Site
Charlotte, North Carolina, 28203, United States
Alkermes Investigational Site
Greensboro, North Carolina, 27405, United States
Alkermes Investigational Site
Winston-Salem, North Carolina, 27103, United States
Alkermes Investigational Site
Canton, Ohio, 44718, United States
Alkermes Investigational Site
Columbus, Ohio, 43221, United States
Alkermes Investigational Site
Dayton, Ohio, 45417, United States
Alkermes Investigational Site
Oklahoma City, Oklahoma, 73104, United States
Alkermes Investigational Site
Charleston, South Carolina, 29406, United States
Alkermes Investigational Site
Greer, South Carolina, 29650, United States
Alkermes Investigational Site
Old Point Station, South Carolina, 29707, United States
Alkermes Investigational Site
Spartanburg, South Carolina, 29307, United States
Alkermes Investigational Site
Franklin, Tennessee, 37064, United States
Alkermes Investigational Site
Knoxville, Tennessee, 37922, United States
Alkermes Investigational Site
Dallas, Texas, 75231, United States
Alkermes Investigational Site
Houston, Texas, 77030, United States
Alkermes Investigational Site
Houston, Texas, 77074, United States
Alkermes Investigational Site
Newport News, Virginia, 23601, United States
Alkermes Investigational Site
Richmond, Virginia, 23226, United States
Alkermes Investigational Site
Seattle, Washington, 98101, United States
Alkermes Investigational Site
Seattle, Washington, 98122, United States
Alkermes Investigational Site
Seattle, Washington, 98133, United States
Alkermes Investigational Site
Dresden, Germany
Alkermes Investigational Site
Leipzig, Germany
Alkermes Investigational Site
Ulm, Germany
Alkermes Investigational Site
Westerstede, Germany
Alkermes Investigational Site
Gdansk, 80-803, Poland
Alkermes Investigational Site
Katowice, 40-123, Poland
Alkermes Investigational Site
Kielce, 25-726, Poland
Alkermes Investigational Site
Lodz, 90-324, Poland
Alkermes Investigational Site
Plewiska, 62-064, Poland
Alkermes Investigational Site
Szczecin, 70-111, Poland
Related Publications (3)
Bowen JD, Stulc J, Hunter SF, Chen H, Lewin JB, Scaramozza M, Bozin I, Then Bergh F. Diroximel Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: NEDA-3 After Re-Baselining in the Phase 3 EVOLVE-MS-1 Study. Adv Ther. 2024 Aug;41(8):3396-3406. doi: 10.1007/s12325-024-02901-1. Epub 2024 Jun 15.
PMID: 38878121DERIVEDWundes A, Wray S, Gold R, Singer BA, Jasinska E, Ziemssen T, de Seze J, Repovic P, Chen H, Hanna J, Messer J, Miller C, Naismith RT. Improved gastrointestinal profile with diroximel fumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: results from the randomized, double-blind, phase III EVOLVE-MS-2 study. Ther Adv Neurol Disord. 2021 Mar 19;14:1756286421993999. doi: 10.1177/1756286421993999. eCollection 2021.
PMID: 33796143DERIVEDNaismith RT, Wundes A, Ziemssen T, Jasinska E, Freedman MS, Lembo AJ, Selmaj K, Bidollari I, Chen H, Hanna J, Leigh-Pemberton R, Lopez-Bresnahan M, Lyons J, Miller C, Rezendes D, Wolinsky JS; EVOLVE-MS-2 Study Group. Diroximel Fumarate Demonstrates an Improved Gastrointestinal Tolerability Profile Compared with Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III EVOLVE-MS-2 Study. CNS Drugs. 2020 Feb;34(2):185-196. doi: 10.1007/s40263-020-00700-0.
PMID: 31953790DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biogen Study Medical Director
- Organization
- Biogen
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2017
First Posted
March 28, 2017
Study Start
March 15, 2017
Primary Completion
June 27, 2019
Study Completion
June 27, 2019
Last Updated
July 14, 2020
Results First Posted
July 14, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share