Clinical trial NCT05288504: A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma.
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Eosinophilic Asthma
Keywords: Non-Eosinophilic Asthma
AVTX-002
Lead sponsor: Avalo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-21
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy of AVTX-002 compared with placebo in patients with poorly controlled non-eosinophilic asthma (NEA).


Eligibility criteria: 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 Corticosteroid for at least 3 consecutive months immediately prior to screening.
* Subjects must have had at least one asthma exacerbation in the last 24 months.

Exclusion Criteria:

* Pulmonary disease other than asthma.
* Currently on biologic therapy. Previous biologic therapy is permitted with adequate washout (12 weeks or 5 half-lives, whichever is longer).
* Use of systemic immunosuppressants within the last 6 months.
* Use of systemic corticosteroids within 6 weeks prior to Screening or use of antibiotics within 4 weeks prior to Screening.
* Subject has alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \>5 upper limit of normal (ULN) and/or serum creatinine concentration \>1.5 mg/dL.
* Subject has hemoglobin ≤10 g/dL, neutrophils ≤1,500/μl, and/or platelets ≤75,000/μl.

Primary outcomes:
measure: 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.
timeFrame: Through Week 14
Secondary outcomes:
measure: Change From Baseline to Week 14 in Forced Expiratory Volume in 1 Second (FEV1[Liters]).
timeFrame: Through Week 14
measure: Time to Asthma Exacerbation.
timeFrame: Through Week 14
measure: Change From Baseline to Week 14 in Fractional Exhaled Nitric Oxide (FeNO).
timeFrame: Through Week 14
measure: Change From Baseline to Week 14 in Asthma Control Questionnaire (ACQ).
timeFrame: Through Week 14
measure: Change From Baseline to Week 14 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12).
timeFrame: Through Week 14
measure: Change From Baseline to Week 14 in Asthma Symptom Diary Score.
timeFrame: Through Week 14
measure: Change From Baseline to Week 14 in European Quality of Life - 5 Dimension 5 Level Questionnaire in Visual Analogue Scale Score (EQ VAS).
timeFrame: Through Week 14
measure: Change From Baseline to Week 14 in Patient Global Impression of Change/Severity.
timeFrame: Through Week 14
measure: Change From Baseline to Week 14 in Clinician Global Impression of Improvement/Severity.
timeFrame: Through Week 14
measure: The Number of Inhalations of Short-acting Beta Agonist (SABA) at Week 14.
timeFrame: Through Week 14
measure: Change From Baseline to Week 14 in Serum Soluble LIGHT Levels (Lymphotoxin-like, Exhibits Inducible Expression, and Competes With Herpes Virus Glycoprotein D for Herpesvirus Entry Mediator, a Receptor Expressed by T Lymphocytes).
timeFrame: Through Week 14
measure: Incidence of Anti-drug Antibodies (ADAs) at Each Timepoint.
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 12 and Week 14.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Neuroscience Research - M3, Wake Research
state: Arizona
city: Sacramento
country: United States
facility: Center For Clinical Trials of Sacramento
state: California
city: Walnut Creek
country: United States
facility: Allergy and Asthma Medical Group of the Bay Area
state: California
city: West Covina
country: United States
facility: Center For Clinical Trials of San Gabriel
state: California
city: Centennial
country: United States
facility: IMMUNOe Research Centers
state: Colorado
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Boynton Beach
country: United States
facility: Helix Biomedics, LLC
state: Florida
city: Miami Gardens
country: United States
facility: Pro-Care Research Center, Corp.
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group LLC
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates LLC
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center
state: Florida
city: Hammond
country: United States
facility: ASHA Clinical Research-Munster, LLC
state: Indiana
city: Louisville
country: United States
facility: Family Allergy and Asthma Research Institute
state: Kentucky
city: Towson
country: United States
facility: Continental Clinical Solutions, LLC
state: Maryland
city: Farmington Hills
country: United States
facility: Pulmonary Research Institute of Southeast Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Midwest Clinical Research
state: Missouri
city: Lincoln
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Edmond
country: United States
facility: OK Clinical Research
state: Oklahoma
city: Nashville
country: United States
facility: Affinity Health
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Center For Clinical Research
state: Texas
city: Boerne
country: United States
facility: South Texas Medical Research Institute, Inc
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions
state: Texas
city: Portsmouth
country: United States
facility: Meridian Clinical Research
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
Study officials:
affiliation: Avalo Therapeutics, Inc.
name: Garry Neil, MD
role: STUDY_DIRECTOR
References: