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ABT-555

Phase 1

Multiple Sclerosis | Small molecule | Immunology |AbbVie Inc.|Last Updated: May 17, 2018

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02601885A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple SclerosisPHASE1 COMPLETED 20 — — Oct 18, 2016Apr 20, 2018May 17, 20188 United States
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Study Endpoints
Primary Endpoints
Number and percentage of participants reporting adverse events
Throughout study from Day 1 to Day 176
Concentration of anti-drug antibody (ADA) titers of ABT-555
Day 1 to Day 176
Time to Maximum observed plasma concentration (Tmax) of ABT-555
Day 1 to Day 176
Maximum observed plasma concentration (Cmax) of ABT-555
Day 1 to Day 176
Area under the concentration curve (AUC) of ABT-555
Day 1 to Day 176
Secondary Endpoints
Percentage of participants who experience relapse and disability progression
Throughout the study to Day 176
Lesion volume of new, newly enlarging T2 hyperintense lesions
Throughout study from Day 0 to Day 113
Number of new, newly-enlarging T2 hyperintense lesions
Throughout study from Day 0 to Day 113
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 2EXPERIMENTALParticipants will receive multiple doses of ABT-555 or placebo
Group 3EXPERIMENTALParticipants will receive multiple doses of ABT-555 or placebo
Group 1EXPERIMENTALParticipants will receive multiple doses of ABT-555 or placebo
Interventions
NameTypeDescription
ABT-555DRUGIntravenous Infusion
PlaceboOTHERIntravenous Infusion
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Currently receiving one of the following MS medications for at least 3 months: beta-interferon (any formulation including the pegylated form), glatiramer acetate (Copaxone®, others), teriflunomide (Aubagio®), fingolimod (Gilenya®), or dimethyl fumarate (Tecfidera®); OR * Has n...

Countries:United States
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Competitive Landscape -Multiple Sclerosis 98 trials
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