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ALKS 8700

Phase 3

Relapsing Remitting Multiple Sclerosis | Small molecule | Immunology |Biogen Inc.|Last Updated: Jul 14, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment506
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03093324A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2PHASE3 COMPLETED 506 — — Mar 15, 2017Jun 27, 2019Jul 14, 202067 United States, Germany +1
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Study Endpoints
Primary Endpoints
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
End of treatment (up to Week 6) for both 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.

Secondary Endpoints
Number of Days With Any IGISIS Individual Symptom Intensity Score ≥2 Relative to Exposure Days in Part B
End of treatment (up to Week 6) for Part B
Number of Days With Any IGISIS Individual Symptom Intensity Score ≥1 Relative to Exposure Days in Parts A and B
End of treatment (up to Week 6) for both Parts A and B
Number of Days With Any IGISIS Individual Symptom Intensity Score ≥3 Relative to Exposure Days in Parts A and B
End of treatment (up to Week 6) for both Parts A and B
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ALKS 8700EXPERIMENTALOral capsules, administered orally twice daily.
Dimethyl FumarateACTIVE_COMPARATOROral capsules, administered orally twice daily.
Interventions
NameTypeDescription
ALKS 8700DRUGAdministered as specified in the treatment arm.
Dimethyl FumarateDRUGAdministered as specified in the treatment arm.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites67

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 fo...

Countries:United StatesGermanyPoland
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