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brodalumab

Phase 3

Psoriatic Arthritis | Small molecule | Other |Bausch Health Companies Inc.|Last Updated: Aug 20, 2020

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_CONTROLLEDDMC
Total Trials1
Total Enrollment484
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02024646Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic ArthritisPHASE3 COMPLETED 484Mar 1, 2014Oct 1, 2015Aug 20, 2020103 United States, Canada +8
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Study Endpoints
Primary Endpoints
ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16
Baseline and 16 Weeks

ACR20 is used as a measurement of the proportion of subjects who are reaching a 20% improvement of tender an swollen joint counts. The higher percent of subjects reaching a higher improvement percentage shows greater success.

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
210 mg brodalumabEXPERIMENTALAdministered via subcutaneous injections.
140 mg brodalumabEXPERIMENTALAdministered via subcutaneous injection.
PlaceboPLACEBO_COMPARATORAdministered via subcutaneous injection until week 24.
Interventions
NameTypeDescription
210 mg brodalumabDRUG210 mg brodalumab administered via subcutaneous injection.
140 mg brodalumabDRUG140 mg brodalumab administered via subcutaneous injection.
PlaceboDRUGPlacebo administered via subcutaneous injection until week 24.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites103

Inclusion Criteria: Subjects has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding distal interphalangeal joints). Subjects must have at least 1 psoriatic skin lesion. Exclusion Criteria: • -Subjec...

Countries:United StatesCanadaFranceGermanyGreeceHungaryLatviaMexicoPolandRussia
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