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Study Drug

Phase 1

Multiple Sclerosis | Small molecule | Neurology |Biogen Inc.|Last Updated: Nov 26, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment104

FDA Designations

No designations recorded

Clinical trial landscape

Study Drug · 1 trial · 1 indication

Phase 1 1
NCT02201849A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy AdultsMultiple Sclerosis
COMPLETED104 Analytics
PHASE1COMPLETED
A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults
Multiple Sclerosis
NCT02201849104
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Study Endpoints

Primary Endpoints

Safety and tolerability will be measured by incidence of adverse events
up to 27 days

Secondary Endpoints

Maximum plasma concentration (Cmax)
up to 27 days
Time to attain Cmax (Tmax)
Up to 27 days
Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast)
Up to 27 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Study DrugEXPERIMENTALOral capsules
Active ControlACTIVE_COMPARATOROral capsules
PlaceboPLACEBO_COMPARATOROral capsules

Interventions

NameTypeDescription
Study DrugDRUG -
Active ControlDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Has a body-mass Index (BMI) \>/=18.0 and \</=32.0 kg/m2 * Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration * Additional criteria may apply Exclusion Criteria: * Is currently pregnant or brea...

Countries:United States
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Competitive Landscape -Multiple Sclerosis 97 trials

CompanyTickerTrialsLead PhaseDrugs
Sanofi SA Sponsored ADRSNY6PHASE3Frexalimab, MRI contrast-enhancing agents
Bristol-Myers Squibb CompanyBMY8PHASE3Ozanimod, Fingolimod
Novartis AG Sponsored ADRNVS23PHASE3Remibrutinib, Teriflunomide
Biogen Inc.BIIB6PHASE3BIIB017, Interferon beta type 1a
Zenas BioPharma, Inc.ZBIO3PHASE3Orelabrutinib
TG Therapeutics, Inc.TGTX8PHASE3Ublituximab
Immunic, Inc.IMUX3PHASE3IMU-838
Amgen Inc.AMGN1PHASE3Ocrelizumab, ABP 692
Eli Lilly and CompanyLLY1PHASE2LY3541860
Moderna, Inc.MRNA1PHASE2mRNA-1195
Kyverna Therapeutics, Inc.KYTX3PHASE2KYV-101, Standard lymphodepletion regimen, Anti-CD20 mAB
Hoffmann-La RocheRHHBY1PHASE3Ocrelizumab, Fingolimod
Tiziana Life Sciences Ltd.TLSA2PHASE2Foralumab
Supernus Pharmaceuticals, Inc.SUPN1PHASE2Phase 2; Low Dose MYOBLOC, Phase 3; MYOBLOC
AstraZeneca PLCAZN1PHASE1AZD0120- Regimen 1, AZD0120- Regimen 2
Gilead Sciences, Inc.GILD1PHASE1KITE-363, Fludarabine, Cyclophosphamide
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE1Obecabtagene autoleucel
TScan Therapeutics, Inc.TCRX1 - Undisclosed
Merck & Co., Inc.MRK1 - Mavenclad
Solana Company Class AHSDT1 - Undisclosed
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