Phase 2
Completed N=25
Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma
Source: ClinicalTrials.gov NCT03469934 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Change From Baseline in Peripheral Eosinophil Count at Day 22 — -0.199; -0.141 10^9 cells/Liters — p=0.5703
Summary
This is a proof of concept study designed to assess the effects of a single intravenous dose of etokimab compared to placebo in adult participants with severe eosinophilic asthma. This study will also assess the safety and tolerability of etokimab in adult participants with severe eosinophilic asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Peripheral Eosinophil Count at Day 22 |
-0.199; -0.141 | 0.5703 |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events |
6; 5; 0; 0 | — |
| PRIMARY Number of Asthma Exacerbations |
1; 1 | — |
| PRIMARY Number of Participants With Positive Anti-drug Antibody |
1; 1; 0; 2; 0; 2 | — |
| SECONDARY Change From Baseline in Peripheral Eosinophil Count at Day 127 |
-0.194; -0.144 | 0.5901 |
| SECONDARY Change From Baseline in Prebronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Day 127 |
0.27; 0.18 | 0.5960 |
| SECONDARY Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Day 127 |
2.10; -0.43 | 0.7993 |
| SECONDARY Change From Baseline in Whole Blood Ex-vivo Induced Interferon Gamma (IFN-γ) |
702.215; 2490.575; -377.747; NA; NA; 5035.623 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of Etokimab |
79.84 | — |
| SECONDARY Time to Maximum Observed Concentration (Tmax) of Etokimab |
1.020 | — |
| SECONDARY Area Under the Concentration-time Curve in Serum From Time Zero (Predose) Extrapolated to Infinite Time (AUC0-inf) of Etokimab |
14400 | — |
| SECONDARY Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of Etokimab |
13590 | — |
| SECONDARY Apparent Total Body Clearance (CL) of Etokimab |
0.02278 | — |
| SECONDARY Apparent Terminal Rate Constant (λz) of Etokimab |
0.002174 | — |
| SECONDARY Apparent Terminal Half-life (t1/2) of Etokimab |
343.3 | — |
| SECONDARY Volume of Distribution During Terminal Phase (Vz) of Etokimab |
10.55 | — |
| SECONDARY Volume of Distribution at Steady State Following Intravenous Dosing (Vss) of Etokimab |
8.485 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with a confirmed clinical diagnosis of eosinophilic asthma
- History of diagnosis of eosinophilic asthma
- Severe asthma diagnosed according to the Global Initiative for Asthma (GINA) 2016
- Body mass index (BMI) of 18 to 38 kilograms per squared meters (kg/m^2) (inclusive) and total body weight > 50 kg (110 pounds)
- Women of childbearing potential must have a negative serum pregnancy test at screening and be willing to use highly effective methods of contraception throughout the study
- Male participants must be willing to use effective methods of contraception during the entire study period.
- Participant must be on high dose inhaled corticosteroids (ICS) plus long-acting beta-2-agonists (LABA)
- Willing and able to comply with the study protocol requirements
- Have the ability to read and understand the study procedures and can communicate meaningfully with the Investigator and staff
Exclusion Criteria
- Have concomitant medical condition(s) which may interfere with the Investigator's ability to evaluate the participant's response to the investigational product (IP)
- Have experienced severe life threatening anaphylactic reactions
- Have received any IP within a period of 3 months or 5 half lives of an IP
- Have received high dose systemic corticosteroids
- Have received treatment with biologics, such as mepolizumab or omalizumab, within 3 months or 5 half lives (whichever is longer) before screening
- Abnormal electrocardiogram (ECG) assessment at screening
- Uncontrolled hypertension, or acute ischemic cardiovascular diseases
- If female, is pregnant or lactating, or intend to become pregnant during the study period
- History (or suspected history) of alcohol or substance abuse within 2 years before screening
- Any comorbidity that the Investigator believes is a contraindication to study participation
- Have any other physical, mental, or medical conditions which, in the opinion of the Investigator, make study participation inadvisable or could confound study assessments
- Planned surgery during the study or 30 days before screening
- History of malignancy within 5 years, except non melanoma skin cancer which has been fully treated with no current active disease
Data sourced from ClinicalTrials.gov (NCT03469934). 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.