A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2

July 13, 2020 updated by: Biogen

A Phase 3 Study in Subjects With Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
506

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany
        • Alkermes Investigational Site
      • Leipzig, Germany
        • Alkermes Investigational Site
      • Ulm, Germany
        • Alkermes Investigational Site
      • Westerstede, Germany
        • Alkermes Investigational Site
  • Poland
      • Gdańsk, Poland, 80-803
        • Alkermes Investigational Site
      • Katowice, Poland, 40-123
        • Alkermes Investigational Site
      • Kielce, Poland, 25-726
        • Alkermes Investigational Site
      • Lodz, Poland, 90-324
        • Alkermes Investigational Site
      • Plewiska, Poland, 62-064
        • Alkermes Investigational Site
      • Szczecin, Poland, 70-111
        • Alkermes Investigational Site
  • United States
    • Alabama
      • Cullman, Alabama, United States, 35058
        • Alkermes Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Alkermes Investigational Site
      • Tucson, Arizona, United States, 85704
        • Alkermes Investigational Site
    • California
      • Long Beach, California, United States, 90806
        • Alkermes Investigational Site
      • San Diego, California, United States, 92103
        • Alkermes Investigational Site
    • Colorado
      • Basalt, Colorado, United States, 81621
        • Alkermes Investigational Site
      • Centennial, Colorado, United States, 80112
        • Alkermes Investigational Site
      • Denver, Colorado, United States, 80209
        • Alkermes Investigational Site
    • Connecticut
      • Middlebury, Connecticut, United States, 06762
        • Alkermes Investigational Site
      • Stamford, Connecticut, United States, 06905
        • Alkermes Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Alkermes Investigational Site
    • Florida
      • Atlantis, Florida, United States, 33462
        • Alkermes Investigational Site
      • Bradenton, Florida, United States, 34209
        • Alkermes Investigational Site
      • Maitland, Florida, United States, 32751
        • Alkermes Investigational Site
      • Naples, Florida, United States, 34105
        • Alkermes Investigational Site
      • Ormond Beach, Florida, United States, 32174
        • Alkermes Investigational Site
      • Sarasota, Florida, United States, 34233
        • Alkermes Investigational Site
      • Tampa, Florida, United States, 33634
        • Alkermes Investigational Site
      • Vero Beach, Florida, United States, 32960
        • Alkermes Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30312
        • Alkermes Investigational Site
      • Atlanta, Georgia, United States, 30327
        • Alkermes Investigational Site
      • Atlanta, Georgia, United States, 30342
        • Alkermes Investigational Site
      • Columbus, Georgia, United States, 31904
        • Alkermes Investigational Site
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Alkermes Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Alkermes Investigational Site
    • Kansas
      • Lenexa, Kansas, United States, 66214
        • Alkermes Investigational Site
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Alkermes Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Alkermes Investigational Site
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422
        • Alkermes Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63104
        • Alkermes Investigational Site
      • Saint Louis, Missouri, United States, 63131
        • Alkermes Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Alkermes Investigational Site
    • New York
      • Patchogue, New York, United States, 11772
        • Alkermes Investigational Site
      • Stony Brook, New York, United States, 11794
        • Alkermes Investigational Site
      • Syracuse, New York, United States, 13210
        • Alkermes Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Alkermes Investigational Site
      • Greensboro, North Carolina, United States, 27405
        • Alkermes Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Alkermes Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Alkermes Investigational Site
      • Columbus, Ohio, United States, 43221
        • Alkermes Investigational Site
      • Dayton, Ohio, United States, 45417
        • Alkermes Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Alkermes Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Alkermes Investigational Site
      • Greer, South Carolina, United States, 29650
        • Alkermes Investigational Site
      • Indian Land, South Carolina, United States, 29707
        • Alkermes Investigational Site
      • Spartanburg, South Carolina, United States, 29307
        • Alkermes Investigational Site
    • Tennessee
      • Franklin, Tennessee, United States, 37064
        • Alkermes Investigational Site
      • Knoxville, Tennessee, United States, 37922
        • Alkermes Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Alkermes Investigational Site
      • Houston, Texas, United States, 77030
        • Alkermes Investigational Site
      • Houston, Texas, United States, 77074
        • Alkermes Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23601
        • Alkermes Investigational Site
      • Richmond, Virginia, United States, 23226
        • Alkermes Investigational Site
    • Washington
      • Seattle, Washington, United States, 98101
        • Alkermes Investigational Site
      • Seattle, Washington, United States, 98122
        • Alkermes Investigational Site
      • Seattle, Washington, United States, 98133
        • Alkermes Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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)

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: ALKS 8700
Oral capsules, administered orally twice daily.
Drug: ALKS 8700
Administered as specified in the treatment arm.
ACTIVE_COMPARATOR: Dimethyl Fumarate
Oral capsules, administered orally twice daily.
Drug: Dimethyl Fumarate
Administered as specified in the treatment arm.
Other Names:
  • Tecfidera

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: End of treatment (up to Week 6) for both 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Days With Any IGISIS Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Part B
Time Frame: End of treatment (up to Week 6) for Part 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 Part B
Number of Days With Any IGISIS Individual Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B
Time Frame: End of treatment (up to Week 6) for both 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
Number of Days With Any IGISIS Individual Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B
Time Frame: End of treatment (up to Week 6) for both 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
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
Time Frame: End of treatment (up to Week 6) for both Parts A and B
GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries.
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
Time Frame: End of treatment (up to Week 6) for both Parts A and B
GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries.
End of treatment (up to Week 6) for both Parts A and B
Number of Days With a GGISIS Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B
Time Frame: End of treatment (up to Week 6) for both Parts A and B
GGISIS is a global scale to assess the overall intensity of GI symptoms (nausea, vomiting, upper abdominal pain, lower abdominal pain, and diarrhea). Participants rated the intensity of GI symptoms via an 11-point numeric rating scale ranging from 0 (did not have) to 10 (extreme). GGISIS was completed by the participants using e-diaries.
End of treatment (up to Week 6) for both Parts A and B
Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period in Parts A and B
Time Frame: End of treatment (up to Week 6) for both 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. Scores were averaged for 5-week treatment period.
End of treatment (up to Week 6) for both Parts A and B
Number of Participants With Adverse Events (AEs)
Time Frame: End of study (up to Week 10)
An AE is any untoward medical occurrence in a participant or 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 (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
End of study (up to Week 10)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alkermes, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 27, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 27, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALK8700-A302
  • 2017-001294-16 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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