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ABT-874

Phase 3

Moderate to Severe Plaque Psoriasis | Small molecule | Dermatology |AbbVie Inc.|Last Updated: Feb 8, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment2,651

FDA Designations

No designations recorded

Clinical trial landscape

ABT-874 · 5 trials · 3 indications

Phase 3 5
NCT00710580Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque PsoriasisModerate to Severe Plaque Psoriasis
COMPLETED350 Analytics
NCT00691964Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque PsoriasisPlaque Psoriasis
COMPLETED347 Analytics
NCT00679731A Study of Safety and Efficacy Comparing ABT-874 Versus Methotrexate in Subjects With Moderate to Severe Plaque PsoriasisPsoriasis
COMPLETED317 Analytics
NCT00626002Open Label Continuation Study in Moderate to Severe PsoriasisModerate to Severe Plaque Psoriasis
COMPLETED2,301 Analytics
NCT00570986A Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque PsoriasisPlaque Psoriasis
COMPLETED1,465 Analytics
PHASE3COMPLETED
Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Moderate to Severe Plaque Psoriasis
NCT00710580350
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PHASE3COMPLETED
Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Plaque Psoriasis
NCT00691964347
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PHASE3COMPLETED
A Study of Safety and Efficacy Comparing ABT-874 Versus Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis
Psoriasis
NCT00679731317
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PHASE3COMPLETED
Open Label Continuation Study in Moderate to Severe Psoriasis
Moderate to Severe Plaque Psoriasis
NCT006260022,301
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PHASE3COMPLETED
A Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Plaque Psoriasis
NCT005709861,465
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Study Endpoints

Primary Endpoints

Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12
12 Weeks
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12
12 Weeks
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24
Week 24
The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24
Week 24
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 52
Week 52
The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52
Week 52
Proportion of subjects achieving PGA "clear" (0) or "minimal" (1) scores by visit.
Visit (12 weeks)
Proportion of subjects achieving a > PASI 50 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit.
Visit (12 weeks)
Proportion of subjects achieving a > PASI 75 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit.
Visit (12 weeks)
AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study
Visit (12 weeks)
PGA
Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12
PASI
Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12

Secondary Endpoints

Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12
12 Weeks
Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 24
Week 24
Changes from Baseline in the DLQI total score at Week 24
Week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BACTIVE_COMPARATOR -
CPLACEBO_COMPARATOR -
1EXPERIMENTAL -
2ACTIVE_COMPARATORArm #2 is used for entire study. At week 12, arm is rerandomized.
3ACTIVE_COMPARATORArm #3 is not used for weeks 0-11. At week 12, arm is rerandomized.

Interventions

NameTypeDescription
ABT-874BIOLOGICALSQ injection 200 mg Weeks 0 and 4; 100 mg Week 8
etanerceptBIOLOGICALSQ injection 50 mg BIW
placeboDRUGSQ placebo injections for ABT-874 and etanercept
MethotrexateDRUG5.0 to 25 mg weekly
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: * Diagnosis of Psoriasis for 6 MO * BSA 10% * PASI 12 or above * PGA 3 or above Exclusion Criteria: * Previous exposure to either etanercept or ABT-874

Countries:United StatesAustriaBelgiumCanadaDenmarkFinlandFranceGermanyGreeceItalyNetherlandsSpainSwedenSwitzerlandUnited Kingdom
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Frequently asked questions about ABT-874

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.