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ABT-555

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

ABT-555 · 1 trial · 1 indication

Phase 1 1
NCT02601885A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple SclerosisMultiple Sclerosis
COMPLETED20 Analytics
PHASE1COMPLETED
A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis
Multiple SclerosisUnlock trial analytics

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 to 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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Frequently asked questions about ABT-555

What is ABT-555 used for in Multiple Sclerosis?

ABT-555 is an investigational small molecule being developed for the treatment of Multiple Sclerosis. It is currently in Phase 1 clinical development, with a completed study in subjects with relapsing forms of Multiple Sclerosis. The drug is not yet approved and remains under investigation.

Who makes ABT-555?

ABT-555 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Multiple Sclerosis.

What phase is ABT-555 in?

ABT-555 is in Phase 1 clinical development. A Phase 1 study has been completed, but the drug is still investigational and has not received regulatory approval. It is being studied for the treatment of relapsing forms of Multiple Sclerosis.

What clinical trials is ABT-555 in?

ABT-555 has one completed clinical trial, registered as NCT02601885, titled "A Multiple Dose Study of ABT-555 in Subjects With Relapsing Forms of Multiple Sclerosis." This Phase 1 study enrolled 20 participants in the United States and was a randomized, double-blind, controlled trial.

Is ABT-555 FDA approved?

ABT-555 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Multiple Sclerosis. The completed Phase 1 trial, NCT02601885, was designed to evaluate the drug's safety and tolerability, but further studies are needed before any approval consideration.