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MEDI3506

Phase 2

Atopic Dermatitis | Small molecule | Immunology |AstraZeneca PLC|Last Updated: Sep 28, 2023

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment148
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04212169Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic DermatitisPHASE2 COMPLETED 148Dec 9, 2019Sep 20, 2022Sep 28, 202338 United States, Australia +4
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Study Endpoints
Primary Endpoints
Percent Change From Baseline to Week 16 in EASI Score
Week 16

The EASI evaluates 4 anatomic regions for severity and extent of key disease signs and focuses on the acute and chronic signs of inflammation (ie, erythema, edema, papulation, excoriation, and lichenification). The maximum score is 72, with higher values indicating more severe disease. Analysis was performed using mixed effect model for repeated measures and MCP-mod dose response model.

Secondary Endpoints
Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16
Week 16
Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16
Week 16
Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16
Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MEDI3506 at dose level 1EXPERIMENTALParticipant will receive multiple doses of MEDI3506 at dose level 1.
MEDI3506 at dose level 2EXPERIMENTALParticipant will receive multiple doses of MEDI3506 at dose level 2.
MEDI3506 at dose level 3EXPERIMENTALParticipant will receive multiple doses of MEDI3506 at dose level 3.
PlaceboPLACEBO_COMPARATORParticipant will receive multiple doses of Placebo
Interventions
NameTypeDescription
MEDI3506DRUGmultiple doses
PlaceboDRUGmultiple doses
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: * Age 18 to 65 years inclusive at the time of consent. * Body mass index between 19.0 and 40.0 kg/m2 inclusive. * Documented history of chronic AD, for at least 1 year prior to screening Visit 1. * Meets at minimum 1 of the criteria, as follows: * History of inadequate respon...

Countries:United StatesAustraliaGermanyPolandSpainUnited Kingdom
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