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ADX-914

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |Q32 Bio Inc.|Last Updated: Oct 3, 2024

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment102
FDA Designations
No designations recorded
Clinical trial landscape

ADX-914 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT05509023Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)Atopic Dermatitis
ACTIVE NOT_RECRUITING102 Analytics
PHASE2ACTIVE NOT_RECRUITING
Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)
Atopic DermatitisUnlock trial analytics
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).

Number of subjects with adverse events
Screening to end of study, up to 18 weeks

Listing and summary of AE incidence

Number of subjects with Physical exam findings
Screening to end of study, up to 18 weeks

Listing of clinically significant changes in PE findings

Number of subjects with Clinical safety lab changes
Screening to end of study, up to 18 weeks

Listing and change from baseline to end of study

Number of subjects with Systolic blood pressure changes
Screening to end of study, up to 18 weeks

Listing and change from baseline to end of study

Number of subjects with Heart rate changes
Screening to end of study, up to 18 weeks

Listing and change from baseline to end of study

Number of subjects with 12 Lead ECG changes
Screening to end of study, up to 18 weeks

Change in 12-lead ECG parameters from baseline to end of study

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 -
Experimental: Cohort 1:1 - 1:6 ADX-914EXPERIMENTALADX-914 single SC dose
Placebo Comparator: Cohort 1:1 - 1:6 placeboPLACEBO_COMPARATORPlacebo single SC dose
Experimental: Cohort 2:1- 2:3EXPERIMENTALADX-914 multiple SC dose once every 2 weeks for 6 weeks
Placebo Comparator: Cohort 2:1- 2:3PLACEBO_COMPARATORPlacebo multiple SC dose once every 2 weeks for 6 weeks
Interventions
NameTypeDescription
ADX-914DRUGSubcutaneous administration of ADX-914
PlaceboDRUGSubcutaneous administration of Placebo
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Eligibility Criteria
Age Range18 Years to 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 StatesAustralia
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05509023primaryCompletionDate: changed
LOWMay 24, 2026NCT05509023studyFirstPostDate: changed