A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma.

Non-Eosinophilic Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05288504
• Other study ID #: AVTX-002-NEA-201
• Status: Completed
• Phase: Phase 2
• Start date: February 24, 2022
• Est. completion date: May 11, 2023

Study information

• Verified date: July 2023
• Source: Avalo Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: May 11, 2023
• Est. primary completion date: May 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Non-Eosinophilic Asthma

Intervention

Drug:
• AVTX-002
Dose of 600 mg administered subcutaneously three times during the study.
• Placebo
Placebo sourced as normal saline administered subcutaneously three times during the study.

Locations

Country	Name	City	State
United States	Amarillo Center For Clinical Research	Amarillo	Texas
United States	South Texas Medical Research Institute, Inc	Boerne	Texas
United States	Helix Biomedics, LLC	Boynton Beach	Florida
United States	IMMUNOe Research Centers	Centennial	Colorado
United States	National Jewish Health	Denver	Colorado
United States	OK Clinical Research	Edmond	Oklahoma
United States	Pulmonary Research Institute of Southeast Michigan	Farmington Hills	Michigan
United States	ASHA Clinical Research-Munster, LLC	Hammond	Indiana
United States	Pioneer Research Solutions	Houston	Texas
United States	Meridian Clinical Research	Lincoln	Nebraska
United States	Family Allergy and Asthma Research Institute	Louisville	Kentucky
United States	Suncoast Research Associates LLC	Miami	Florida
United States	Suncoast Research Group LLC	Miami	Florida
United States	Pro-Care Research Center, Corp.	Miami Gardens	Florida
United States	Affinity Health	Nashville	Tennessee
United States	Innovation Medical Research Center	Palmetto Bay	Florida
United States	Meridian Clinical Research	Portsmouth	Virginia
United States	Clinical Research Partners, LLC	Richmond	Virginia
United States	Center For Clinical Trials of Sacramento	Sacramento	California
United States	Midwest Clinical Research	Saint Louis	Missouri
United States	Continental Clinical Solutions, LLC	Towson	Maryland
United States	Tucson Neuroscience Research - M3, Wake Research	Tucson	Arizona
United States	Allergy and Asthma Medical Group of the Bay Area	Walnut Creek	California
United States	Center For Clinical Trials of San Gabriel	West Covina	California

Sponsors (1)

Lead Sponsor	Collaborator
Avalo Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the ability of AVTX-002 to improve asthma control in subjects with poorly controlled non-eosinophilic asthma (NEA) based on the proportion of patients who experience asthma related events.	Proportion 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	Through Week 14
Secondary	To assess the safety and tolerability of AVTX-002.	Change from baseline in forced expiratory volume in 1 second (FEV1)	Through Week 14
Secondary	To assess the safety and tolerability of AVTX-002.	Time to asthma exacerbation	Through Week 14
Secondary	To assess the safety and tolerability of AVTX-002.	Change from baseline in fractional exhaled nitric oxide (FeNO)	Through Week 14
Secondary	To assess the safety and tolerability of AVTX-002.	Change from baseline in Asthma Control Questionnaire (ACQ)	Through Week 14
Secondary	To assess the safety and tolerability of AVTX-002.	Change from baseline in Standardized Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(S)+12)	Through Week 14
Secondary	To assess the safety and tolerability of AVTX-002.	Change from baseline in Asthma Symptom Diary Score	Through Week 14
Secondary	To assess the safety and tolerability of AVTX-002.	Change from baseline in European Quality of Life - 5 Dimension 5 level Questionnaire	Through Week 14
Secondary	To assess the safety and tolerability of AVTX-002.	Change from baseline in Patient Global Impression of Change/Severity	Through Week 14
Secondary	To assess the safety and tolerability of AVTX-002.	Change from baseline in Clinician Global Impression of Improvement/Severity	Through Week 14
Secondary	To assess the safety and tolerability of AVTX-002.	Incidence of short-acting beta agonist (SABA) use	Through Week 14
Secondary	To assess the safety and tolerability of AVTX-002.	Safety and tolerability will be assessed by incidence of adverse events (AEs). Clinically significant changes from baseline in clinical laboratory tests, vital signs, and physical examinations will be recorded as AEs.	Through Week 14
Secondary	To evaluate biomarkers of pharmacodynamic (PD) activity and mechanism of action of AVTX-002.	Change from baseline in serum soluble LIGHT levels	Through Week 14
Secondary	To evaluate the immunogenicity of AVTX-002.	Incidence of anti-drug antibodies (ADAs)	Through Week 14