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Alicaforsen

Phase 3

Crohn's Disease | Small molecule | Immunology |Ionis Pharmaceuticals, Inc.|Last Updated: Dec 5, 2022

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-BlindUNCONTROLLED
Total Trials2
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00048295Alicaforsen (ISIS 2302) in Patients With Active Crohn's DiseasePHASE3 COMPLETED 150May 1, 2002 -Aug 15, 202215 Belgium, Czechia +4
NCT00048113Alicaforsen (ISIS 2302) in Patients With Active Crohn's DiseasePHASE3 COMPLETED 150Jan 10, 2001Apr 27, 2002Dec 5, 202230 United States, Canada
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
PurposeTREATMENT
Interventions
NameTypeDescription
AlicaforsenDRUG -
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria 1. Age \>/= 12 years 2. Weight \>/= 36 kg 3. CDAI score of 220 - 400 4. Documentation of Crohn's disease activity by endoscopy, biopsy or imaging in the last 2 years 5. No TNF-α inhibitor treatment for three months prior to first study drug infusion Exclusion Criteria 1. Known ...

Countries:BelgiumCzechiaGermanyItalyPolandSpainUnited StatesCanada
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