A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02634307 |
Recruitment Status :
Completed
First Posted : December 18, 2015
Results First Posted : June 24, 2022
Last Update Posted : July 26, 2022
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Sponsor:
Biogen
Collaborator:
Alkermes, Inc.
Information provided by (Responsible Party):
Biogen
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Multiple Sclerosis |
Intervention |
Drug: ALKS 8700 |
Enrollment | 1057 |
Participant Flow
Recruitment Details | Participants were enrolled at investigational sites in North America and Europe from 10 December 2015 to 11 November 2021. |
Pre-assignment Details | De Novo (who had not participated in any prior study of ALKS 8700) and Rollover participants (who had completed the Treatment Period of Study ALK8700-A302) were enrolled in this study. |
Arm/Group Title | De Novo | Rollover: ALKS 8700 | Rollover: DMF |
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Participants who had not received ALKS 8700 or dimethyl fumarate (DMF) were administered ALKS 8700 231 milligrams (mg) capsules orally, twice daily (BID) on Days 1 to 7 followed by ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 8 up to Week 96. | Participants rolled over from study ALK870-A302 who had already received ALKS 8700 prior to Day 1 were administered ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 1 up to Week 96. | Participants rolled over from study ALK870-A302 who had already received DMF prior to Day 1 were administered ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 1 up to Week 96. |
Period Title: Overall Study | |||
Started | 593 | 239 | 225 |
Safety Population | 593 | 239 | 225 |
Full Analysis Set (FAS) Population | 582 | 235 | 224 |
Completed | 468 | 168 | 164 |
Not Completed | 125 | 71 | 61 |
Reason Not Completed | |||
Adverse Event | 50 | 24 | 14 |
Lost to Follow-up | 21 | 5 | 6 |
Pregnancy | 5 | 1 | 3 |
Withdrawal by Subject | 38 | 24 | 18 |
Non-Compliance with Study Drug | 0 | 2 | 2 |
Lack of Efficacy | 1 | 5 | 3 |
Physician Decision | 7 | 5 | 5 |
Reason not Specified | 3 | 5 | 10 |
Baseline Characteristics
Arm/Group Title | De Novo | Rollover: ALKS 8700 | Rollover: DMF | Total | |
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Participants who had not received ALKS 8700 or DMF were administered ALKS 8700 231 mg capsules orally, BID on Days 1 to 7 followed by ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 8 up to Week 96. | Participants rolled over from study ALK870-A302 who had already received ALKS 8700 prior to Day 1 were administered ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 1 up to Week 96. | Participants rolled over from study ALK870-A302 who had already received DMF prior to Day 1 were administered ALKS 8700 462 mg (as two 231 mg capsules) orally, BID from Day 1 up to Week 96. | Total of all reporting groups | |
Overall Number of Baseline Participants | 593 | 239 | 225 | 1057 | |
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Safety Analysis Set included all enrolled participants who received at least one dose of ALKS 8700.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 593 participants | 239 participants | 225 participants | 1057 participants | |
41.5 (10.96) | 44.0 (11.00) | 43.7 (9.77) | 42.5 (10.78) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 593 participants | 239 participants | 225 participants | 1057 participants | |
Female |
427 72.0%
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165 69.0%
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170 75.6%
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762 72.1%
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Male |
166 28.0%
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74 31.0%
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55 24.4%
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295 27.9%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 593 participants | 239 participants | 225 participants | 1057 participants | |
Hispanic or Latino |
25 4.2%
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5 2.1%
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10 4.4%
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40 3.8%
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Not Hispanic or Latino |
568 95.8%
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234 97.9%
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215 95.6%
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1017 96.2%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Race | Number Analyzed | 593 participants | 239 participants | 225 participants | 1057 participants |
White |
547 92.2%
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220 92.1%
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205 91.1%
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972 92.0%
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Black or African American |
37 6.2%
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19 7.9%
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16 7.1%
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72 6.8%
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Asian |
4 0.7%
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0 0.0%
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1 0.4%
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5 0.5%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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1 0.4%
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1 0.1%
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Other |
5 0.8%
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0 0.0%
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2 0.9%
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7 0.7%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Our agreement is subject to confidentiality but generally the PI can publish, for non-commercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Results Point of Contact
Name/Title: | US Biogen Clinical Trial Center |
Organization: | Biogen |
Phone: | 866-633-4636 |
EMail: | clinicaltrials@biogen.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Biogen |
ClinicalTrials.gov Identifier: | NCT02634307 |
Other Study ID Numbers: |
ALK8700-A301 2015-005160-41 ( EudraCT Number ) |
First Submitted: | December 16, 2015 |
First Posted: | December 18, 2015 |
Results First Submitted: | May 30, 2022 |
Results First Posted: | June 24, 2022 |
Last Update Posted: | July 26, 2022 |