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EVOLVE-MS-2: A randomized, double-blind, phase 3 study of the gastrointestinal tolerability of ALKS 8700 versus dimethyl fumarate in relapsing-remitting multiple sclerosis
ECTRIMS Online Library. Naismith R.
Oct 26, 2017; 200363
Robert Naismith
Robert Naismith
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Abstract: P708

Type: Poster

Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression

Background: Phase 3 and real-world studies have shown that gastrointestinal (GI) events are an important concern for patients taking oral dimethyl fumarate (DMF), approved for the treatment of relapsing forms of multiple sclerosis (MS). ALKS 8700 is a prodrug of monomethyl fumarate, the active metabolite of DMF. ALKS 8700 has physicochemical properties that are distinct from DMF, and thus is designed to effectively treat relapsing forms of MS in a manner similar to DMF but with the potential for improved GI tolerability.
Objectives: EVOLVE-MS-2 (NCT03093324) evaluates the safety and GI tolerability of ALKS 8700 and DMF in patients with relapsing-remitting MS (RRMS).
Methods: In this double-blind, Phase 3 study, ~420 patients with RRMS will be randomized 1:1 to oral treatment with ALKS 8700 462 mg (twice daily) or DMF 240 mg (twice daily) for 5 weeks. Key GI symptoms will be assessed using 2 patient-reported symptom-rating scales: the Individual GI Symptom and Impact Scale (IGISIS) and the Global GI Symptom and Impact Scale (GGISIS). The IGISIS assesses the incidence, intensity, onset, duration, and functional impact of 5 individual GI symptoms: nausea, vomiting, upper and lower abdominal pain, and diarrhea. The GGISIS assesses the overall intensity, bothersomeness, and functional impact of GI symptoms experienced over the past 24 hrs. Key inclusion criteria: age 18-65 yrs, confirmed diagnosis of RRMS (2010 revised McDonald criteria), Expanded Disability Status Scale score ≤ 6.0, and no evidence of relapse within 30 days prior to randomization. Key exclusion criteria: progressive forms of MS or prior treatment with DMF. Primary and secondary endpoints will be based on the IGISIS and GGISIS. Safety will be assessed via adverse events and standard clinical, laboratory, and imaging measures. Patients completing this study will be eligible to participate in an ongoing open-label, long-term safety study (EVOLVE-MS-1; NCT02634307).
Results: Patient enrollment began in March 2017. The study is currently recruiting patients from 17 sites in the United States. Patient demographics and baseline characteristics as of September 2017 will be presented.
Conclusions: GI tolerability issues with DMF can negatively affect patient experience and adherence. EVOLVE-MS-2 will provide important insight into the GI tolerability of ALKS 8700 compared with DMF in patients with RRMS.
Disclosure:
RTN has consulted for Acorda, Alkermes, Bayer, Biogen, EMD Serono, Genentech, Genzyme, Mallinckrodt, Novartis, and Pfizer and was on the speaker bureau for Acorda, Biogen, and Genzyme. RAL-P, DR, TG, LvM are employees and stockholders in Alkermes, Inc. AJL has consulted for Alkermes, Ardelyx, Salix, Prometheus, Allergen, Valeant, and Ironwood.
JSW has served on advisory boards, data monitoring or steering committees, has consulting agreements, or received speaker honoraria from the following entities: AbbVie, AcademicCME, ACTRIMS, Alkermes, Bayer HealthCare, Biogen, Bionest, Celgene, Clene Nanomedicine, CMSC, ECTRIMS, Forward Pharma A/S, Medday Pharmaceuticals, Novartis Pharmaceuticals, PRIME, Roche Genentech, Sanofi Genzyme, Strategic Consultants International, Takeda, Teva Pharmaceuticals, WebMD; royalties are received for out licensed monoclonal antibodies through UTHealth from Millipore Corporation. This study is sponsored by Alkermes, Inc., Waltham, MA, USA.

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