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ABT-874/Human monoclonal antibody against IL-12

Phase 3

Moderate to Severe Plaque Psoriasis | Monoclonal antibody | Dermatology |AbbVie Inc.|Trials Updated: Feb 8, 2013

ABT-874/Human monoclonal antibody against IL-12 development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jul 2004

ABT-874/Human monoclonal antibody against IL-12 target and mechanism

ModalityMonoclonal antibody

Also known as ABT-874

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials6
Total Enrollment4,995

FDA Designations

No designations recorded

ABT-874/Human monoclonal antibody against IL-12 clinical trials

ABT-874/Human monoclonal antibody against IL-12 · 6 trials · 4 indications

Phase 3 5Phase 2 1
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
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

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

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
ABT-874/Human monoclonal antibody against IL-12DRUG -
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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/Human monoclonal antibody against IL-12

What is ABT-874?

ABT-874 is an investigational human monoclonal antibody developed by AbbVie Inc. (ticker ABBV) for immune-mediated conditions. It has been studied in moderate to severe plaque psoriasis and multiple sclerosis. The program reached Phase 3 clinical development, and the completed trials focused primarily on plaque psoriasis.

What is ABT-874 used for in plaque psoriasis?

ABT-874 was studied for the treatment of moderate to severe chronic plaque psoriasis in adults. Phase 3 trials compared it with etanercept, methotrexate, and placebo. It is an investigational agent and is not described as approved for psoriasis or any other indication.

Who makes ABT-874?

ABT-874 is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie sponsored the Phase 3 clinical program evaluating the antibody in moderate to severe plaque psoriasis and related conditions.

What phase is ABT-874 in?

ABT-874 reached Phase 3 clinical development. The program includes completed Phase 3 trials in moderate to severe plaque psoriasis, and no active trials are listed. It remains an investigational drug rather than an approved therapy.

What clinical trials is ABT-874 in?

ABT-874 has been evaluated in completed Phase 3 trials including NCT00710580, NCT00691964, NCT00679731, and NCT00626002. These studies compared ABT-874 with etanercept, methotrexate, or placebo in adults with moderate to severe plaque psoriasis across the United States and several European countries.

Is ABT-874 the same as the human monoclonal antibody against IL-12?

Yes. ABT-874 is also known as a human monoclonal antibody against IL-12. Both names refer to the same investigational antibody developed by AbbVie Inc. (ABBV) and studied in Phase 3 trials for moderate to severe plaque psoriasis.

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