Eosinophilic AsthmaPhase 2NCT03469934
Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma
A Phase 2 study testing Etokimab in people with Eosinophilic Asthma, run by AnaptysBio, Inc. at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Eosinophilic Asthma
- What is being tested?
- Etokimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 14 Nov 2017to 30 Oct 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States4 sites
OK Clinical Research, LLC
Edmond, Oklahoma, 73034
Allergy & Asthma Center of Southern Oregon
Medford, Oregon, 97504
Midwest Allergy Sinus Asthma
Normal, Illinois, 61761
Pulmonary & Critical Care Specialists
Novi, Michigan, 48375
United Kingdom3 sites
Glenfield Hospital
Leicester, Leicestershire, LE3 9QP
Medicines Evaluation Unit
Manchester, Greater Manchester, M239Q
Churchill Hospital
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: Placebo-Controlled Proof of Concept Study to Investigate ANB020 Activity in Adult Patients With Severe Eosinophilic Asthma
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.
- Conditions
- Eosinophilic Asthma
- Being tested
- Etokimab, Placebo
- Medical subject headings
- Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtokimabBiological
Also called ANB020
Administered on Day 1 over 1 hour by IV infusion
PlaceboDrug
Administered on Day 1 over 1 hour by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Etokimab | Experimental | Participants received a single dose of 300 milligrams (mg) etokimab administered on Day 1 by intravenous (IV) infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. Receives: Biological: Etokimab |
| Placebo | Placebo comparator | Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Peripheral Eosinophil Count at Day 22
Measured: Baseline, Day 22
Number of Participants With Treatment-Emergent Adverse Events
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
An AE was considered "serious" if there was any of the following outcomes: death, life-threatening, Inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events.
Treatment-emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the date and time of the study drug infusion.
Measured: From first dose to Day 127
Number of Asthma Exacerbations
Asthma exacerbation was defined as follows:
- Use of systemic corticosteroids (or a temporary increase in a stable oral corticosteroid background dose) for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids. OR
- An emergency room/urgent care visit (defined as evaluation and treatment for <24 hours in an emergency department or urgent care center) due to asthma that required systemic corticosteroids (as per above). OR
- An inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours due to asthma).
Measured: From first dose to Day 127
Number of Participants With Positive Anti-drug Antibody
Measured: Day 1, Day 8, Day 36, Day 85, Day 106, end of study (up to Day 127)
Secondary outcomes (13)
Change From Baseline in Peripheral Eosinophil Count at Day 127
Measured: Baseline, Day 127
Change From Baseline in Prebronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Day 127
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Measured: Baseline, Day 127
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Day 127
Measurement of FeNO was performed in accordance with the guidelines published by American Thoracic Society/European Respiratory Society (ATS/ERS).
Measured: Baseline, Day 127
Change From Baseline in Whole Blood Ex-vivo Induced Interferon Gamma (IFN-γ)
Blood samples for ex vivo induced IFN-γ assessment were collected in a sodium heparin tube. The measurement of ex vivo induced IFN-γ was performed using validated assay method.
Measured: Baseline, Day 8, Day 36, Day 85, Day 106, and End of Study (up to Day 127)
Maximum Observed Concentration (Cmax) of Etokimab
Cmax was obtained directly from the observed concentration versus time data.
Measured: pre-dose, 0.50 hours post-start of infusion, end of infusion (EOI), EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Time to Maximum Observed Concentration (Tmax) of Etokimab
Tmax was obtained directly from the observed concentration versus time data.
Measured: pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Area Under the Concentration-time Curve in Serum From Time Zero (Predose) Extrapolated to Infinite Time (AUC0-inf) of Etokimab
AUC0-inf was calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the apparent terminal rate constant.
Measured: pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of Etokimab
AUC0-last was calculated by linear up/log down trapezoidal summation.
Measured: pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Apparent Total Body Clearance (CL) of Etokimab
CL was calculated as dose/ AUC0-inf.
Measured: pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Apparent Terminal Rate Constant (λz) of Etokimab
λz was determined by linear regression of the terminal points of the log-linear concentration-time curve.
Measured: pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Apparent Terminal Half-life (t1/2) of Etokimab
Apparent terminal half-life was determined as (natural logarithm of 2 [ln2] divided by λz).
Measured: pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Volume of Distribution During Terminal Phase (Vz) of Etokimab
Vz was estimated by dividing the systemic clearance by λz.
Measured: pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Volume of Distribution at Steady State Following Intravenous Dosing (Vss) of Etokimab
Volume of distribution at steady state following intravenous dosing was calculated as [([AUMClast + ([tlast*Clast]/λz) + Clast/λz^2]/ AUC(0-inf)) - TI/ 2]*CL, Clast is last observed (quantifiable) plasma concentration, where AUMClast is the area under the moment curve from the time of dosing to Clast, tlast is the time of Clast, and TI is infusion duration.
Measured: pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start14 Nov 2017
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnaptysBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Randazzo, MD, Study director, AnaptysBio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469934
- Sponsor's protocol ID
- ANB020-004
- Other IDs
- 2017-000647-40, 2017
- Status last verified
- Apr 2023
- First submitted
- 28 Feb 2018
- Last updated
- 16 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pavord ID, Marquette A, Kahm P, Pinkstaff J, Sacco N, Londei M. Single-dose Phase 2a trial of etokimab (anti-IL-33) in severe eosinophilic asthma. Paper presented at the European Academy of Allergy and Clinical Immunology (EEACI) Congress 2019; June 1-5, 2019; Lisbon, Portugal.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled Proof of Concept Study to Investigate ANB020 Activity in Adult Patients With Severe Eosinophilic Asthma
- ClinicalTrials.gov ID
- NCT03469934
- Acronym / sponsor ID
- ANB020-004
- Conditions
- Eosinophilic Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AnaptysBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Posted 16 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etokimab | Experimental | Biological: EtokimabParticipants received a single dose of 300 milligrams (mg) etokimab administered on Day 1 by intravenous (IV) infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtokimabAlso: ANB020Administered on Day 1 over 1 hour by IV infusion | Biological | Etokimab |
| PlaceboAdministered on Day 1 over 1 hour by IV infusion | Drug | Placebo |
Primary outcome
Change From Baseline in Peripheral Eosinophil Count at Day 22
Time frame: Baseline, Day 22
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From first dose to Day 127
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE was considered "serious" if there was any of the following outcomes: death, life-threatening, Inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. Treatment-emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the date and time of the study drug infusion.
Number of Asthma Exacerbations
Time frame: From first dose to Day 127
Asthma exacerbation was defined as follows: 1. Use of systemic corticosteroids (or a temporary increase in a stable oral corticosteroid background dose) for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids. OR 2. An emergency room/urgent care visit (defined as evaluation and treatment for <24 hours in an emergency department or urgent care center) due to asthma that required systemic corticosteroids (as per above). OR 3. An inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours due to asthma).
Number of Participants With Positive Anti-drug Antibody
Time frame: Day 1, Day 8, Day 36, Day 85, Day 106, end of study (up to Day 127)
13 secondary outcomes
Change From Baseline in Peripheral Eosinophil Count at Day 127
Time frame: Baseline, Day 127
Change From Baseline in Prebronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Day 127
Time frame: Baseline, Day 127
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Day 127
Time frame: Baseline, Day 127
Change From Baseline in Whole Blood Ex-vivo Induced Interferon Gamma (IFN-γ)
Time frame: Baseline, Day 8, Day 36, Day 85, Day 106, and End of Study (up to Day 127)
Maximum Observed Concentration (Cmax) of Etokimab
Time frame: pre-dose, 0.50 hours post-start of infusion, end of infusion (EOI), EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Time to Maximum Observed Concentration (Tmax) of Etokimab
Time frame: pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Area Under the Concentration-time Curve in Serum From Time Zero (Predose) Extrapolated to Infinite Time (AUC0-inf) of Etokimab
Time frame: pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of Etokimab
Time frame: pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Apparent Total Body Clearance (CL) of Etokimab
Time frame: pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Apparent Terminal Rate Constant (λz) of Etokimab
Time frame: pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Apparent Terminal Half-life (t1/2) of Etokimab
Time frame: pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Volume of Distribution During Terminal Phase (Vz) of Etokimab
Time frame: pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Volume of Distribution at Steady State Following Intravenous Dosing (Vss) of Etokimab
Time frame: pre-dose, 0.50 hours post-start of infusion, EOI, EOI+3 hours, EOI+6 hours, and then 24, 168, 504, 840, 1512 hours post-start of infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationPavord ID, Marquette A, Kahm P, Pinkstaff J, Sacco N, Londei M. Single-dose Phase 2a trial of etokimab (anti-IL-33) in severe eosinophilic asthma. Paper presented at the European Academy of Allergy and Clinical Immunology (EEACI) Congress 2019; June 1-5, 2019; Lisbon, Portugal.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Randazzo, MD study director
AnaptysBio, Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etokimab in people with Eosinophilic Asthma, run by AnaptysBio, Inc. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Peripheral Eosinophil Count at Day 22 (time frame: Baseline, Day 22). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03469934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.