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

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093324
• Other study ID #: ALK8700-A302
• Secondary ID: 2017-001294-16
• Status: Completed
• Phase: Phase 3
• Start date: March 15, 2017
• Est. completion date: June 27, 2019

Study information

• Verified date: July 2020
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 506
• Est. completion date: June 27, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• ALKS 8700
Administered as specified in the treatment arm.
• Dimethyl Fumarate
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
Germany	Alkermes Investigational Site	Dresden
Germany	Alkermes Investigational Site	Leipzig
Germany	Alkermes Investigational Site	Ulm
Germany	Alkermes Investigational Site	Westerstede
Poland	Alkermes Investigational Site	Gdansk
Poland	Alkermes Investigational Site	Katowice
Poland	Alkermes Investigational Site	Kielce
Poland	Alkermes Investigational Site	Lodz
Poland	Alkermes Investigational Site	Plewiska
Poland	Alkermes Investigational Site	Szczecin
United States	Alkermes Investigational Site	Albuquerque	New Mexico
United States	Alkermes Investigational Site	Alexandria	Louisiana
United States	Alkermes Investigational Site	Atlanta	Georgia
United States	Alkermes Investigational Site	Atlanta	Georgia
United States	Alkermes Investigational Site	Atlanta	Georgia
United States	Alkermes Investigational Site	Atlantis	Florida
United States	Alkermes Investigational Site	Basalt	Colorado
United States	Alkermes Investigational Site	Bradenton	Florida
United States	Alkermes Investigational Site	Canton	Ohio
United States	Alkermes Investigational Site	Centennial	Colorado
United States	Alkermes Investigational Site	Charleston	South Carolina
United States	Alkermes Investigational Site	Charlotte	North Carolina
United States	Alkermes Investigational Site	Columbus	Georgia
United States	Alkermes Investigational Site	Columbus	Ohio
United States	Alkermes Investigational Site	Cullman	Alabama
United States	Alkermes Investigational Site	Dallas	Texas
United States	Alkermes Investigational Site	Dayton	Ohio
United States	Alkermes Investigational Site	Denver	Colorado
United States	Alkermes Investigational Site	Des Moines	Iowa
United States	Alkermes Investigational Site	Detroit	Michigan
United States	Alkermes Investigational Site	Evanston	Illinois
United States	Alkermes Investigational Site	Franklin	Tennessee
United States	Alkermes Investigational Site	Golden Valley	Minnesota
United States	Alkermes Investigational Site	Greensboro	North Carolina
United States	Alkermes Investigational Site	Greer	South Carolina
United States	Alkermes Investigational Site	Houston	Texas
United States	Alkermes Investigational Site	Houston	Texas
United States	Alkermes Investigational Site	Indian Land	South Carolina
United States	Alkermes Investigational Site	Knoxville	Tennessee
United States	Alkermes Investigational Site	Lenexa	Kansas
United States	Alkermes Investigational Site	Long Beach	California
United States	Alkermes Investigational Site	Maitland	Florida
United States	Alkermes Investigational Site	Middlebury	Connecticut
United States	Alkermes Investigational Site	Naples	Florida
United States	Alkermes Investigational Site	Newport News	Virginia
United States	Alkermes Investigational Site	Oklahoma City	Oklahoma
United States	Alkermes Investigational Site	Ormond Beach	Florida
United States	Alkermes Investigational Site	Patchogue	New York
United States	Alkermes Investigational Site	Phoenix	Arizona
United States	Alkermes Investigational Site	Richmond	Virginia
United States	Alkermes Investigational Site	Saint Louis	Missouri
United States	Alkermes Investigational Site	Saint Louis	Missouri
United States	Alkermes Investigational Site	Saint Louis	Missouri
United States	Alkermes Investigational Site	San Diego	California
United States	Alkermes Investigational Site	Sarasota	Florida
United States	Alkermes Investigational Site	Seattle	Washington
United States	Alkermes Investigational Site	Seattle	Washington
United States	Alkermes Investigational Site	Seattle	Washington
United States	Alkermes Investigational Site	Spartanburg	South Carolina
United States	Alkermes Investigational Site	Stamford	Connecticut
United States	Alkermes Investigational Site	Stony Brook	New York
United States	Alkermes Investigational Site	Syracuse	New York
United States	Alkermes Investigational Site	Tampa	Florida
United States	Alkermes Investigational Site	Tucson	Arizona
United States	Alkermes Investigational Site	Vero Beach	Florida
United States	Alkermes Investigational Site	Washington	District of Columbia
United States	Alkermes Investigational Site	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Alkermes, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Days With Any IGISIS Individual Symptom Intensity Score =2 Relative to Exposure Days in 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
Secondary	Number of Days With Any IGISIS Individual Symptom Intensity Score =1 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	Number of Days With Any IGISIS Individual Symptom Intensity Score =3 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	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	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
Secondary	Number of Days With a GGISIS Symptom Intensity Score =2 Relative to Exposure Days in 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
Secondary	Number of Days With a GGISIS Symptom Intensity Score =3 Relative to Exposure Days in 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
Secondary	Worst IGISIS Individual Symptom Intensity Score During the 5-Week Treatment Period 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. Scores were averaged for 5-week treatment period.	End of treatment (up to Week 6) for both Parts A and B
Secondary	Number of Participants With Adverse Events (AEs)	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)