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ADX-914

Phase 2

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

Target and mechanism

Molecular targetIL-7Rα
Target classProtein
ModalitySmall molecule

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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Frequently asked questions about ADX-914

What is ADX-914 used for in atopic dermatitis?

ADX-914 is an investigational small molecule being studied for the treatment of moderate to severe atopic dermatitis. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug targets IL-7Rα, a protein involved in immune signaling.

What does ADX-914 target?

ADX-914 targets IL-7Rα, a protein receptor involved in immune cell signaling. By modulating this target, the drug aims to address inflammatory pathways relevant to atopic dermatitis. This mechanism is being evaluated in clinical trials for safety and efficacy.

Who makes ADX-914?

ADX-914 is being developed by Q32 Bio Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in atopic dermatitis. Q32 Bio Inc. is publicly traded under the ticker QTTB.

What phase is ADX-914 in?

ADX-914 is in Phase 2 clinical development for atopic dermatitis. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory bodies. The Phase 2 trial is actively not recruiting participants, and earlier Phase 1 studies have been completed.

What clinical trials is ADX-914 in?

ADX-914 has been studied in two clinical trials. A Phase 1 trial (NCT04485481) evaluated single and multiple ascending doses in healthy volunteers and has been completed. A Phase 2 trial (NCT05509023), called SIGNAL-AD, is evaluating safety and efficacy in patients with moderate to severe atopic dermatitis and is active but not recruiting.

Is ADX-914 the same as any other drug?

ADX-914 is the primary name for this investigational drug. No alternative names have been reported in clinical trial registrations. It is a small molecule targeting IL-7Rα, developed by Q32 Bio Inc., and is being studied for atopic dermatitis.