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MEDI2070

Phase 2

Crohn's Disease | Small molecule | Immunology |AstraZeneca PLC|Last Updated: May 26, 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-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment121
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01714726Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.PHASE2 COMPLETED 121Feb 1, 2013Dec 14, 2016May 26, 202180 United States, Canada +7
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Study Endpoints
Primary Endpoints
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 8
Week 8

A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes subject reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity. The CDAI response at Week 8 is defined as either CDAI score of less than (\<)150 or CDAI reduction from baseline of at least 100 points, where baseline was last non-missing observation prior to first administration of the study drug. Modified Intent-to-treat (mITT)population was analysed for this end point, which included all subjects who were randomized and received at least 1 dose of study drug in double-blind period.

Secondary Endpoints
Percentage of Participants With CDAI-70 Point Improvement at Week 8
Week 8
Percentage of Participants With CDAI Response at Week 12
Week 12
Percentage of Participants With CDAI Remission at Week 8
Week 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALMEDI2070 iv infusion
2PLACEBO_COMPARATORplacebo iv infusion
open-labelEXPERIMENTALMEDI2070 sc injection; open-label arm is available for all subjects upon completion of first placebo-controlled treatment period
Interventions
NameTypeDescription
MEDI2070DRUG1 iv infusion on Week 0 and Week 4
placeboDRUG1 iv infusion on Week 0 and Week 4
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites80

Inclusion Criteria: * Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening. * Men or women age 18 - 65 years at the time of screening. * Moderate-sever active Crohn's Disease (CD), defined by a Crohn's Disease Activity Index (CDAI) score higher or equal 220 and lower or...

Countries:United StatesCanadaCzechiaFranceGermanyHungaryItalyPolandSpain
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