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

Biogen

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: ALKS 8700

Study type: Interventional

Funder types: Industry

Identifiers

NCT02634307

ALK8700-A301

2015-005160-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1,057 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,057 participants in 1 patient group

ALKS 8700

Experimental group

Description:

Oral capsules taken twice daily.

Treatment:

Drug: ALKS 8700