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Hemay808

Phase 2

Atopic Dermatitis | Small molecule | Immunology |Co-Diagnostics, Inc.|Last Updated: Mar 1, 2024

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
NCT04352595A Phase Ⅱ Study of Hemay808 for Atopic Dermatitis PatientsPHASE2 COMPLETED 148Apr 24, 2020Apr 2, 2021Mar 1, 20242 China
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Study Endpoints
Primary Endpoints
The change in the EASI score relative to the baseline.
Day 29

EASI Clinical Signs Severity Sum Score change from Baseline at Day 29

Secondary Endpoints
The percentage of subjects achieving Investigator's Global Score (IGA) response which improvement ≥ 2 from baseline.
Day 8, Day 15, Day 22, Day 28
The percentage of subjects achieving Investigator's Global Score (IGA) score 0-1.
Day 8, Day 15, Day 22, Day 28
The change in the IGA score relative to the baseline.
Day 8, Day 15, Day 22, Day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1% Hemay808EXPERIMENTAL -
3% Hemay808EXPERIMENTAL -
7% Hemay808EXPERIMENTAL -
vehiclePLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Hemay808DRUGHemay808 is a onitment of Hemay028, a small molecule PDE4 inhibitor.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * ≥18 years old and ≤65 years old, gender is not limited; * It met the diagnostic criteria for atopic dermatitis (AD) of Hanifin\&Rajka, and the history of AD before screening was ≥6 months; * The investigator's overall score (IGA) at the screening period/baseline visit was 2-3;...

Countries:China
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