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ADX-914

Phase 2

Atopic Dermatitis | Small molecule | Immunology |Q32 Bio Inc.|Last Updated: Oct 3, 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_CONTROLLED
Total Trials1
Total Enrollment102
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05509023Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)PHASE2 ACTIVE NOT_RECRUITING 102Sep 30, 2022Dec 1, 2024Oct 3, 202424 United States
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Study Endpoints
Primary Endpoints
Part A only: Safety parameters including incidence of serious adverse events and adverse events of special interest
14 Weeks
Part A and B: Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 14 for ADX-914 vs placebo
14 Weeks

Severity score is based on evaluation of severity of atopic dermatitis in 4 body regions (head and neck, trunk, upper limbs, and lower limbs). The minimum score is 0 (less severe) and maximum score is 72 (most severe).

Secondary Endpoints
Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score
24 Weeks
Mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score
24 Weeks
Proportion of subjects achieving Eczema Area and Severity Index (EASI) reduction of 50%, 75% and 90%
24 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ADX-914EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ADX-914DRUGSubcutaneous administration of ADX-914
PlaceboDRUGSubcutaneous administration of Placebo
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: 1. Age ≥18 years, inclusive, at time of informed consent, with chronic AD (duration of disease ≥3 years) diagnosed by the Eichenfield revised criteria of Hanifin and Rajka. 2. Moderate to severe disease activity at baseline and screening defined as: 1. BSA affected ≥10% 2...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05509023primaryCompletionDate: changed
LOWMay 24, 2026NCT05509023studyFirstPostDate: changed