A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1

• ClinicalTrials.gov Identifier: NCT02634307
• Recruitment Status: Active, not recruiting
• First Posted: December 18, 2015
• Last Update Posted: September 14, 2020
• Sponsor: Biogen
• Collaborator: Alkermes, Inc.
• Information provided by (Responsible Party): Biogen

Tracking Information

• First Submitted Date: December 16, 2015
• First Posted Date: December 18, 2015
• Last Update Posted Date: September 14, 2020
• Actual Study Start Date: December 10, 2015
• Estimated Primary Completion Date: May 17, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 12, 2020): Number of Participants with Adverse Events and Serious Adverse Events [ Time Frame: Up to 98 weeks ]

Original Primary Outcome Measures (submitted: December 16, 2015)

Safety will be demonstrated by incidence of Adverse Events [ Time Frame: Up to 96 weeks ]

All enrolled subjects who receive at least one dose of ALKS 8700 will be used in the safety and tolerability analysis

Current Secondary Outcome Measures (submitted: March 12, 2020)

• Anualized Relapse Rate [ Time Frame: Up to 96 weeks ]
• Percentage of Participants with MS Relapse [ Time Frame: Up to 96 weeks ]
• Progression of Disability on the Expanded Disability Status Scale (EDSS) [ Time Frame: Day 1, 85,169, 253, 337, 421, 505, 589, 673 ]
  The EDSS is used to measure and evaluate MS patients' level of functioning. The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The range of main categories include (0) = normal neurologic examination; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS.
• Timed 25-foot Walk Test (T25-FW) Scores [ Time Frame: Day 1, 85,169, 253, 337, 421, 505, 589, 673 ]
  The T25-FW is a reliable quantitative mobility and leg function performance test based on a timed 25-foot walk. The subject is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. Subjects are allowed to use assistive devices (canes, crutches, walkers) as needed. The time is calculated from when the lead foot crosses the start point to when the subject has reached the 25-foot mark. The task is immediately administered again by having the subject walk back the same distance. The score for the T25-FW is the average of the 2 completed trials.
• EuroQol Group Health Outcome Measure (EQ-5D-5L) Score [ Time Frame: Day 1,169, 337, 505, 673 ]
  The EQ-5D-5L is an instrument designed to assess decrements in health. The EQ-5D-5L includes a Visual Analog Scale (VAS) and a descriptive system that defines health in terms of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response categories corresponding to the level of severity (i.e., no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems).
• 12-item Short Form Health Survey (SF-12) [ Time Frame: Day 1, 169, 337, 505, 673 ]
  Quality of life will be assessed using the 12-item Short-Form health survey Version 2.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Multiple Sclerosis

Intervention

Drug: ALKS 8700

Administered as specified in the treatment arm.

Study Arms

Experimental: ALKS 8700

Oral capsules taken twice daily.

Intervention: Drug: ALKS 8700

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: September 26, 2019): 1057
• Original Estimated Enrollment (submitted: December 16, 2015): 600
• Estimated Study Completion Date: July 31, 2021
• Estimated Primary Completion Date: May 17, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Bulgaria, Canada, Germany, Poland, Russian Federation, Serbia, Spain, Ukraine, United States

Administrative Information

• NCT Number: NCT02634307
• Other Study ID Numbers: ALK8700-A301; 2015-005160-41 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Biogen
• Study Sponsor: Biogen
• Collaborators: Alkermes, Inc.

Investigators

• Study Director: Medical Director; Biogen

• PRS Account: Biogen
• Verification Date: September 2020