NCT03093324

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 506 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	ALKS 8700	Administered as specified in the treatment arm.
DRUG	Dimethyl Fumarate	Administered as specified in the treatment arm.

Timeline

• Start date: 2017-03-15
• Primary completion: 2019-06-27
• Completion: 2019-06-27
• First posted: 2017-03-28
• Last updated: 2020-07-14
• Results posted: 2020-07-14

Locations

67 sites across 3 countries: United States, Germany, Poland

Regulatory

• FDA-regulated drug study