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AVTX-002

Phase 2

Non-Eosinophilic Asthma | Small molecule | Respiratory |Avalo Therapeutics, Inc.|Last Updated: Sep 5, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment91

FDA Designations

No designations recorded

Clinical trial landscape

AVTX-002 · 1 trial · 1 indication

Phase 2 1
NCT05288504A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma.Non-Eosinophilic Asthma
COMPLETED91 Analytics
PHASE2COMPLETED
A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma.
Non-Eosinophilic AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

The Ability of AVTX-002 to Improve Asthma Control in Subjects With Poorly Controlled Non-eosinophilic Asthma (NEA) Based on the Percentage of Patients Who Experience Asthma Related Events.
Through Week 14

Percentage of patients who experience any of the following asthma related events: * ≥6 additional reliever puffs of Short-Acting Beta-Agonist (compared to baseline) in a 24-hour period on 2 consecutive days or, * increase in inhaled corticosteroid dose ≥4 times than the dose at baseline or, * a decrease in peak flow of 30% or more (compared to baseline) on 2 consecutive days of treatment, or * an asthma exacerbation requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days, or * a hospitalization or emergency room visit because of an asthma exacerbation

Secondary Endpoints

Change From Baseline to Week 14 in Forced Expiratory Volume in 1 Second (FEV1[Liters]).
Through Week 14
Time to Asthma Exacerbation.
Through Week 14
Change From Baseline to Week 14 in Fractional Exhaled Nitric Oxide (FeNO).
Through Week 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AVTX-002EXPERIMENTALApproximately 40 subjects will receive AVTX-002 at a dose of 600 mg three times during the study.
PlaceboPLACEBO_COMPARATORApproximately 40 subjects will receive placebo sourced as normal saline three times during the study.

Interventions

NameTypeDescription
AVTX-002DRUGDose of 600 mg administered subcutaneously three times during the study.
PlaceboDRUGPlacebo sourced as normal saline administered subcutaneously three times during the study.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Documented non-eosinophilic asthma diagnosis (\<300 eosinophils/μL). * Symptoms consistent with a diagnosis of asthma that is poorly controlled as determined by an ACQ score ≥ 1.5. * Poorly controlled asthma despite the use of a Long-Acting Beta-Agonists and Inhaled Corticoste...

Countries:United States
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Frequently asked questions about AVTX-002

What is AVTX-002 used for?

AVTX-002 is an investigational small molecule being developed for the treatment of poorly controlled non-eosinophilic asthma. It is currently in Phase 2 clinical development and has not been approved by the FDA.

Who makes AVTX-002?

AVTX-002 is being developed by Avalo Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AVTX.

What phase is AVTX-002 in?

AVTX-002 is in Phase 2 clinical development. A Phase 2 clinical trial evaluating the drug for the treatment of poorly controlled non-eosinophilic asthma has been completed.

What clinical trials is AVTX-002 in?

AVTX-002 has one completed Phase 2 clinical trial, identified as NCT05288504. This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of AVTX-002 in 91 adult patients with poorly controlled non-eosinophilic asthma in the United States.

Is AVTX-002 FDA approved?

AVTX-002 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of poorly controlled non-eosinophilic asthma.