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Humira

Phase 3

Psoriasis | Monoclonal antibody | Immunology |Abbott Laboratories|Last Updated: Apr 11, 2011

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment203
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00513370A Canadian Open-Label Access Program to Evaluate Adalimumab When Added to Inadequate Therapy for the Treatment of PsoriasisPHASE3 COMPLETED 203Sep 1, 2007 -Apr 11, 201127 Canada
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Study Endpoints
Primary Endpoints
Number of Subjects With Psoriasis Area and Severity Index (PASI) 75 Response at 16 Weeks
16 weeks

PASI 75 is a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI). The PASI scale runs from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree

Secondary Endpoints
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks
16 and 24 weeks
Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks
16 and 24 weeks
Number of Subjects With Improvement in Physician's Global Assessment for Psoriasis (PGA)
16 and 24 weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
Humira (adalimumab)BIOLOGICALStudy drug will be provided as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). Loading dose of 80 mg of adalimumab subcutaneously (sc) at Baseline, and 40 mg of adalimumab sc at Week 1, followed by 40 mg of adalimumab sc every other week (eow) for 24 weeks.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Subject has a clinical diagnosis of psoriasis for at least 6 months prior to the Screening, as determined by subject interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator * Subject must have stable plaque psoriasis ...

Countries:Canada
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