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

Biogen

Status and phase: Completed; Phase 3

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: Dimethyl Fumarate; Drug: ALKS 8700

Study type: Interventional

Funder types: Industry

Identifiers

NCT03093324

ALK8700-A302

2017-001294-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 506 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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506 participants in 2 patient groups

ALKS 8700

Experimental group

Description:

Oral capsules, administered orally twice daily.

Treatment:

Drug: ALKS 8700

Dimethyl Fumarate

Active Comparator group

Description:

Oral capsules, administered orally twice daily.

Treatment:

Drug: Dimethyl Fumarate