Clinical trial NCT02634307: A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1
Official title: A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: MS
Relapsing Remitting Multiple Sclerosis
RRMS
dimethyl fumarate
DMF
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Alkermes, Inc.
First posted: 2015-12-18
Enrollment: 1057
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS). The secondary objective of this study is to evaluate treatment effect over time in adult participants with RRMS treated with ALKS 8700.


Eligibility criteria: Key Inclusion Criteria:

* Has a confirmed diagnosis of RRMS
* Neurologically stable with no evidence of relapse within 30 days prior to Visit 2

Exclusion Criteria:

* 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
* Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
* History of clinically significant cardiovascular, pulmonary, gastrointestinal, dermatologic, psychiatric, neurologic (other than MS), and/or other major disease that would preclude participation in a clinical trial
* History of a myocardial infarction, including a silent myocardial infarction identified on ECG, or unstable angina

NOTE: Other protocol defined Includison/Exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From first dose to two weeks after last dose of study drug (Up to 98 weeks)
measure: Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities
timeFrame: From first dose to two weeks after last dose of study drug (Up to 98 weeks)
measure: Number of Participants With Potentially Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
timeFrame: From first dose to two weeks after last dose of study drug (Up to 98 weeks)
measure: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit
timeFrame: Up to 98 weeks
measure: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities
timeFrame: From first dose to two weeks after last dose of study drug (Up to 98 weeks)
Secondary outcomes:
Other outcomes:
measure: Annualized Relapse Rate (ARR)
timeFrame: Up to 96 weeks
measure: Percentage of Participants With Multiple Sclerosis (MS) Relapse
timeFrame: Up to 96 weeks
measure: Change From Baseline in Expanded Disability Status Scale (EDSS) Score
timeFrame: Baseline up to Week 96
measure: Change From Baseline in Timed 25-Foot Walk Test (T25-FW) Score
timeFrame: Baseline up to Week 96
measure: Change From Baseline in the EuroQol 5-Dimension 5-Level Visual Analog Scale (EQ-5D-5L VAS) Score
timeFrame: Baseline up to Week 96
measure: Change From Baseline in the EQ-5D-5L Index Score
timeFrame: Baseline up to Week 96
measure: Change From Baseline in the 12-item Short Form Health Survey (SF-12) Score
timeFrame: Baseline up to Week 96
measure: Time to Onset of 12-week Confirmed Disability Progression
timeFrame: Up to Week 96
measure: Percentage of Participants With No Evidence of Disease Activity (NEDA) at Week 96
timeFrame: Week 96
Locations:
city: Cullman
country: United States
facility: Alkermes Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Alkermes Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Alkermes Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Alkermes Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Alkermes Investigational Site
state: Arizona
city: Berkeley
country: United States
facility: Alkermes Investigational Site
state: California
city: Loma Linda
country: United States
facility: Alkermes Investigational Site
state: California
city: Long Beach
country: United States
facility: Alkermes Investigational Site
state: California
city: San Diego
country: United States
facility: Alkermes Investigational Site
state: California
city: Basalt
country: United States
facility: Alkermes Investigational Site
state: Colorado
city: Centennial
country: United States
facility: Alkermes Investigational Site
state: Colorado
city: Denver
country: United States
facility: Alkermes Investigational Site
state: Colorado
city: Middlebury
country: United States
facility: Alkermes Investigational Site
state: Connecticut
city: Stamford
country: United States
facility: Alkermes Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Alkermes Investigational Site
state: District of Columbia
city: Atlantis
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Bradenton
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Maitland
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Naples
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Tampa
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: Alkermes Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Columbus
country: United States
facility: Alkermes Investigational Site
state: Georgia
city: Evanston
country: United States
facility: Alkermes Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Alkermes Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Alkermes Investigational Site
state: Indiana
city: Des Moines
country: United States
facility: Alkermes Investigational Site
state: Iowa
city: Overland Park
country: United States
facility: Alkermes Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Alkermes Investigational Site
state: Kentucky
city: Alexandria
country: United States
facility: Alkermes Investigational Site
state: Louisiana
city: Baton Rouge
country: United States
facility: Alkermes Investigational Site
state: Louisiana
city: Detroit
country: United States
facility: Alkermes Investigational Site
state: Michigan
city: Traverse City
country: United States
facility: Alkermes Investigational Site
state: Michigan
city: Golden Valley
country: United States
facility: Alkermes Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Alkermes Investigational Site
state: Missouri
city: Albuquerque
country: United States
facility: Alkermes Investigational Site
state: New Mexico
city: Patchogue
country: United States
facility: Alkermes Investigational Site
state: New York
city: Plainview
country: United States
facility: Alkermes Investigational Site
state: New York
city: Stony Brook
country: United States
facility: Alkermes Investigational Site
state: New York
city: Syracuse
country: United States
facility: Alkermes Investigational Site
state: New York
city: Charlotte
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Alkermes Investigational Site
state: North Carolina
city: Canton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Alkermes Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Alkermes Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: Alkermes Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Alkermes Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Alkermes Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Alkermes Investigational Site
state: South Carolina
city: Rock Hill
country: United States
facility: Alkermes Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Alkermes Investigational Site
state: South Carolina
city: Cordova
country: United States
facility: Alkermes Investigational Site
state: Tennessee
city: Franklin
country: United States
facility: Alkermes Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Alkermes Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Houston
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Houston
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Lubbock
country: United States
facility: Alkermes Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Alkermes Investigational Site
state: Utah
city: Newport News
country: United States
facility: Alkermes Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Alkermes Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Alkermes Investigational Site
state: Washington
city: Seattle
country: United States
facility: Alkermes Investigational Site
state: Washington
city: Seattle
country: United States
facility: Alkermes Investigational Site
state: Washington
city: Brugge
country: Belgium
facility: Alkermes Investigational Site
city: Fraiture
country: Belgium
facility: Alkermes Investigational Site
city: La Louviere
country: Belgium
facility: Alkermes Investigational Site
city: Blagoevgrad
country: Bulgaria
facility: Alkermes Investigational Site
city: Pleven
country: Bulgaria
facility: Alkermes Investigational Site
city: Sofia
country: Bulgaria
facility: Alkermes Investigational Site
city: Sofia
country: Bulgaria
facility: Alkermes Investigational Site
city: Sofia
country: Bulgaria
facility: Alkermes Investigational Site
city: Gatineau
country: Canada
facility: Alkermes Investigational Site
state: Quebec
city: Berlin
country: Germany
facility: Alkermes Investigational Site
city: Berlin
country: Germany
facility: Alkermes Investigational Site
city: Dresden
country: Germany
facility: Alkermes Investigational Site
city: Leipzig
country: Germany
facility: Alkermes Investigational Site
city: Ulm
country: Germany
facility: Alkermes Investigational Site
city: Ulm
country: Germany
facility: Alkermes Investigational Site
city: Westerstede
country: Germany
facility: Alkermes Investigational Site
city: Gdansk
country: Poland
facility: Alkermes Investigational Site
city: Katowice
country: Poland
facility: Alkermes Investigational Site
city: Katowice
country: Poland
facility: Alkermes Investigational Site
city: Kielce
country: Poland
facility: Alkermes Investigational Site
city: Krakow
country: Poland
facility: Alkermes Investigational Site
city: Lodz
country: Poland
facility: Alkermes Investigational Site
city: Lublin
country: Poland
facility: Alkermes Investigational Site
city: Plewiska
country: Poland
facility: Alkermes Investigational Site
city: Szczecin
country: Poland
facility: Alkermes Investigational Site
city: Krasnoyarsk
country: Russian Federation
facility: Alkermes Investigational Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Alkermes Investigational Site
city: Belgrade
country: Serbia
facility: Alkermes Investigational Site
city: Kragujevac
country: Serbia
facility: Alkermes Investigational Site
city: Nis
country: Serbia
facility: Alkermes Investigational Site
city: Barcelona
country: Spain
facility: Alkermes Investigational Site
city: Madrid
country: Spain
facility: Alkermes Investigational Site
city: Santa Cruz de Tenerife
country: Spain
facility: Alkermes Investigational Site
city: Dnipro
country: Ukraine
facility: Alkermes Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: Alkermes Investigational Site
city: Kharkiv
country: Ukraine
facility: Alkermes Investigational Site
city: Kharkiv
country: Ukraine
facility: Alkermes Investigational Site
city: Lviv
country: Ukraine
facility: Alkermes Investigational Site
city: Odessa
country: Ukraine
facility: Alkermes Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: Alkermes Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: Alkermes Investigational Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Wray S, Then Bergh F, Wundes A, Arnold DL, Drulovic J, Jasinska E, Bowen JD, Negroski D, Naismith RT, Hunter SF, Gudesblatt M, Chen H, Lyons J, Shankar SL, Kapadia S, Mendoza JP, Singer BA. Efficacy and Safety Outcomes with Diroximel Fumarate After Switching from Prior Therapies or Continuing on DRF: Results from the Phase 3 EVOLVE-MS-1 Study. Adv Ther. 2022 Apr;39(4):1810-1831. doi: 10.1007/s12325-022-02068-7. Epub 2022 Feb 24.
citation: Naismith RT, Wolinsky JS, Wundes A, LaGanke C, Arnold DL, Obradovic D, Freedman MS, Gudesblatt M, Ziemssen T, Kandinov B, Bidollari I, Lopez-Bresnahan M, Nangia N, Rezendes D, Yang L, Chen H, Liu S, Hanna J, Miller C, Leigh-Pemberton R. Diroximel fumarate (DRF) in patients with relapsing-remitting multiple sclerosis: Interim safety and efficacy results from the phase 3 EVOLVE-MS-1 study. Mult Scler. 2020 Nov;26(13):1729-1739. doi: 10.1177/1352458519881761. Epub 2019 Nov 4.
citation: Palte MJ, Wehr A, Tawa M, Perkin K, Leigh-Pemberton R, Hanna J, Miller C, Penner N. Improving the Gastrointestinal Tolerability of Fumaric Acid Esters: Early Findings on Gastrointestinal Events with Diroximel Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis from the Phase 3, Open-Label EVOLVE-MS-1 Study. Adv Ther. 2019 Nov;36(11):3154-3165. doi: 10.1007/s12325-019-01085-3. Epub 2019 Sep 19.