Recent Updates
Recently added Catalysts

ABT-874

Phase 3

Plaque Psoriasis | Monoclonal antibody | Immunology |AbbVie Inc.|Last Updated: Feb 8, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment1,812
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00691964Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque PsoriasisPHASE3 COMPLETED 347 — — May 1, 2008Mar 1, 2009Jan 21, 201335 United States
NCT00570986A Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque PsoriasisPHASE3 COMPLETED 1,465 — — Nov 1, 2007Jun 1, 2009Feb 8, 2013116 United States, Canada
Unlock Drug Trial Details
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
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
DLQI
Change from Baseline in DLQI total score vs. placebo at Week 12
NAPSI
% change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
BACTIVE_COMPARATOR -
CPLACEBO_COMPARATOR -
1PLACEBO_COMPARATORArm #1 is used for entire study. At week 12, arm is rerandomized.
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
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites35

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 StatesCanada
Unlock Eligibility Criteria