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Delayed and mesalazine

Phase 3

Colitis, Ulcerative | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jun 11, 2021

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment280
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00503243Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative ColitisPHASE3 COMPLETED 280 — — Sep 30, 2003Jan 17, 2005Jun 11, 20211 United States
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Study Endpoints
Primary Endpoints
Percentage of subjects in remission (Ulcerative Colitis Disease Activity Index score of <= 1, with scores of 0 for rectal bleeding and stool frequency, and a sigmoidoscopy score reduction of 1 point or more from baseline
8 weeks
Secondary Endpoints
Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score
8 weeks
Change in the UC-DAI score
8 weeks
Change in symptoms (rectal bleeding and stool frequency)
2, 4 and 8 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Delayed and extended release mesalazineDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * newly diagnosed or diagnosis of relapsing (relapsed \<= 6 weeks to baseline) mild to moderate ulcerative colitis * women not of childbearing potential or WOCP who agreed to use an effective contraceptive method Exclusion Criteria: * severe ulcerative colitis or relapsed for ...

Countries:United States
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