Phase 2
Completed N=91
A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma.
Non-Eosinophilic Asthma
Source: ClinicalTrials.gov NCT05288504 ↗
Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: 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. — 12; 14 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
12; 14 | — |
| SECONDARY Change From Baseline to Week 14 in Forced Expiratory Volume in 1 Second (FEV1[Liters]). |
-0.149; -0.203 | — |
| SECONDARY Time to Asthma Exacerbation. |
84.9; 78.1; 52.1; 42.6 | — |
| SECONDARY Change From Baseline to Week 14 in Fractional Exhaled Nitric Oxide (FeNO). |
6.1; 3.8 | — |
| SECONDARY Change From Baseline to Week 14 in Asthma Control Questionnaire (ACQ). |
-0.22; -0.34 | — |
| SECONDARY Change From Baseline to Week 14 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12). |
0.18; 0.49 | — |
| SECONDARY Change From Baseline to Week 14 in Asthma Symptom Diary Score. |
-0.15; -0.39 | — |
| SECONDARY Change From Baseline to Week 14 in European Quality of Life - 5 Dimension 5 Level Questionnaire in Visual Analogue Scale Score (EQ VAS). |
2.9; 5.6 | — |
| SECONDARY Change From Baseline to Week 14 in Patient Global Impression of Change/Severity. |
0.0; -0.4; 3.4; 3.0 | — |
| SECONDARY Change From Baseline to Week 14 in Clinician Global Impression of Improvement/Severity. |
-0.3; -0.5; 3.4; 3.2 | — |
| SECONDARY The Number of Inhalations of Short-acting Beta Agonist (SABA) at Week 14. |
1.28; 0.97 | — |
| SECONDARY 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). |
-114.52; 11.63 | — |
| SECONDARY Incidence of Anti-drug Antibodies (ADAs) at Each Timepoint. |
0; 1; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Documented non-eosinophilic asthma diagnosis ( 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.
Data sourced from ClinicalTrials.gov (NCT05288504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.