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Methoxsalen +ECP

Phase 2

Crohn's Disease | Small molecule | Immunology |Icon Plc|Last Updated: Oct 19, 2016

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 Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00221026Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's DiseasePHASE2 COMPLETED 25Dec 1, 2004Jun 1, 2006Oct 19, 201615 United States, Austria +2
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Study Endpoints
Primary Endpoints
Crohns Disease Activity Index
12 weeks

The CDAI is a questionaire giving the change of disease acitvity.This study wil llook or a decrease in CDAI score of at least 100.

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
drugEXPERIMENTALECP + Uvadex given for 12 weeks.
Interventions
NameTypeDescription
Methoxsalen +ECPDRUGECP + Uvadex given at weeks 1-12 weeks.
Extracorporeal PhotopheresisPROCEDUREECP given at weeks 1 through 12.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Signed and dated informed consent must be obtained prior to conducting any study procedure. * Patients must be greater than or equal to 18 years of age. * Patients must have a body weight greater than or equal to 40 kg (88 lb). * Patients must have had Crohn's disease for at l...

Countries:United StatesAustriaBelgiumGermany
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