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Anti IL-12 monoclonal antibody/ABT-874

Phase 2

Psoriasis | Small molecule | Immunology |AbbVie Inc.|Last Updated: Jan 18, 2013

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment180
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00292396Efficacy and Safety of ABT-874 in Subjects With Moderate to Severe Chronic Plaque PsoriasisPHASE2 COMPLETED 180Nov 1, 2005Apr 1, 2008Jan 18, 201324 United States, Canada
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Study Endpoints
Primary Endpoints
Proportion of subjects with clinical response relative to Baseline PASI score
Week 12, Week 40 and Week 60
Secondary Endpoints
Quality of Life Surveys
Week 12, Week 48 and Week 60
Clinical response indicators
Week 12, Week 48 and Week 60
Safety parameters
Monthly through duration of study
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORAnti IL-12 monoclonal antibody/ABT-874, up to 12 weeks, 200 mg every week for 12 weeks
2ACTIVE_COMPARATORAnti IL-12 monoclonal antibody/ABT-874, 200 mg QOW for 12 weeks
3ACTIVE_COMPARATORAnti IL-12 monoclonal antibody/ABT-874, 100 mg QOW in 12 weeks
4ACTIVE_COMPARATORAnti IL-12 monoclonal antibody/ABT-874, 200 mg times 4 doses in 12 weeks
5ACTIVE_COMPARATORAnti IL-12 monoclonal antibody/ABT-874, 200 mg times 1 dose in 12 weeks
6PLACEBO_COMPARATORplacebo, 12 doses
Interventions
NameTypeDescription
Anti IL-12 monoclonal antibody/ABT-874DRUGPlease see Arm Description for intervention description and details.
placeboDRUG12 doses
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history. * Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis Exclusion Criteria: * Subject had previously rece...

Countries:United StatesCanada
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