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ABT-874/Human monoclonal antibody against IL-12

Phase 2

Multiple Sclerosis | Small molecule | Neurology |AbbVie Inc.|Last Updated: Jan 4, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment215

FDA Designations

No designations recorded

Clinical trial landscape

ABT-874/Human monoclonal antibody against IL-12 · 1 trial · 1 indication

Phase 2 1
NCT00086671Safety and Effectiveness of Two Doses of ABT-874 as Compared to Placebo in Subjects With Multiple Sclerosis (MS)Multiple Sclerosis
COMPLETED215 Analytics
PHASE2COMPLETED
Safety and Effectiveness of Two Doses of ABT-874 as Compared to Placebo in Subjects With Multiple Sclerosis (MS)
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Comparison of the cumulative number of Gd enhanced (T1 weighted) lesions during the treatment phase
24 weeks
Safety and clinical laboratory parameters
monthly
vital signs
monthly

Secondary Endpoints

Magnetic Resonance Imaging endpoints
Screening
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
ABT-874 200 mg weeklyEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
ABT 874 QOWEXPERIMENTAL -

Interventions

NameTypeDescription
ABT-874/Human monoclonal antibody against IL-12DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion Criteria: * Age between 18 and 55 years * Diagnosis of active relapse within 12 months of screening. * At least one relapse within 12 months of screening. * Must be able to walk at least 65 feet with or without assistance * Off Copaxone or interferon therapy for two months prior to screen...

Countries:United StatesCanadaGermanyNetherlandsUnited Kingdom
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Frequently asked questions about ABT-874/Human monoclonal antibody against IL-12

What is ABT-874 used for?

ABT-874 is an investigational drug being studied for the treatment of psoriasis, including moderate to severe chronic plaque psoriasis. It has also been investigated for use in multiple sclerosis. The drug is in Phase 3 clinical development and is not yet approved by regulatory authorities.

Who makes ABT-874?

ABT-874 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. AbbVie is conducting clinical trials to evaluate the safety and efficacy of ABT-874 in patients with moderate to severe plaque psoriasis.

What phase is ABT-874 in?

ABT-874 is in Phase 3 clinical development. Multiple Phase 3 trials have been completed, including studies comparing ABT-874 to placebo and to etanercept in patients with moderate to severe chronic plaque psoriasis. The drug remains investigational and has not received FDA approval.

What clinical trials has ABT-874 been in?

ABT-874 has been studied in several completed Phase 3 trials. NCT00570986 compared two dosing regimens of ABT-874 to placebo in 1,465 patients with plaque psoriasis. NCT00626002 was an open-label continuation study in 2,301 patients with moderate to severe psoriasis. NCT00691964 and NCT00710580 compared ABT-874 to etanercept and placebo in patients with chronic plaque psoriasis.

Is ABT-874 the same as briakinumab?

ABT-874 is also known as briakinumab. It is an investigational monoclonal antibody being developed by AbbVie for the treatment of moderate to severe plaque psoriasis. The drug has been evaluated in Phase 3 clinical trials, but it is not currently approved for any indication.