Chronic RhinosinusitisPhase 2NCT03614923
Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
A Phase 2 study testing Etokimab and Mometasone Furoate Nasal Spray in people with Chronic Rhinosinusitis, run by AnaptysBio, Inc. at 28 sites in United States.
Trial summary
A study to evaluate the safety and efficacy of multiple doses of etokimab in adults with chronic rhinosinusitis with nasal polyps. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- Etokimab and Mometasone Furoate Nasal Spray
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 28 sitesUnited States
- Study dates
- 29 Nov 2018to 26 Oct 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically confirmed diagnosis of CRSwNP
- Nasal polyp score (NPS) ≥ 4 out of a maximum score for both nostrils (with at least a score of 1 for each nostril).
- 22 Item Sino-Nasal Outcome Test (SNOT-22) score > 15.
- Presence of at least two of the following symptoms prior to screening: nasal blockade/obstruction/congestion or nasal discharge (anterior/posterior nasal drip); facial pain/pressure; reduction or loss of smell
- Body mass index (BMI) of 18 to 42 kg/m^2 (inclusive) and total body weight > 50 kg (110 lb). BMI=weight (kg)/(height [m^2]).
Who cannot join
- Use of investigational drugs or prohibited therapy for this study within 8 weeks before screening or 5 half-lives, whichever is longer.
- Have experienced severe life threatening anaphylactic reactions.
- Participation in any interventional study for the treatment of CRSwNP in the 3 months before screening.
- If female, is pregnant or lactating, or intend to become pregnant during the study period.
- History (or suspected history) of alcohol or substance abuse.
- Current smokers or former smokers with a smoking history of ≥ 10 pack years. If a patient has less than 10 pack years smoking history, he or she should have quit smoking at least 2 months before screening to enroll in the study.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Chesapeake Clinical Research Inc.
Baltimore, Maryland, 21236
Bellingham Asthma Allergy Immunology Clinic
Bellingham, Washington, 98225
Treasure Valley Medical Research
Boise, Idaho, 83706
Alliance Research Institute
Canoga Park, California, 91304
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599
Chicago ENT
Chicago, Illinois, 60657
Colorado Allergy Asthma Centers
Denver, Colorado, 80230
Intermountain Ear Nose Throat Specialist
Draper, Utah, 84020
Ohio Sinus Institute
Dublin, Ohio, 43016
Fort Worth ENT Berkson Medical
Fort Worth, Texas, 76109
Allergy, Asthma Sinus Center, SC
Greenfield, Wisconsin, 53228
Asthma & Allergy Institute
Little Rock, Arkansas, 72209
Advanced ENT and Allergy
Louisville, Kentucky, 40213
Charlotte Eye Ear Nose and Throat Associates
Matthews, North Carolina, 28105
Ear Nose and Throat Associates of Texas
McKinney, Texas, 75070
Intermed Medical Research Center
Miami, Florida, 33175
Advanced Research Institute, Inc.
New Port Richey, Florida, 34653
ENT and Allergy Associates ENTA LLP
New York, New York, 10016
Eastern Virginia Medical School EVMS Medical Group
Norfolk, Virginia, 23507
National Allergy and Asthma Research
North Charleston, South Carolina, 29420
Allergy Asthma Clinical Research Center
Oklahoma City, Oklahoma, 73120
DaVinci Research
Roseville, California, 95661
Sacramento Ear Nose and Throat Surgical and Medical Group Inc. - SacENT
Sacramento, California, 95815
Allergy & Asthma Medical Group and Research Center
San Diego, California, 92123
Chrysalis Clinical Research
St. George, Utah, 84790
Clinical Research Consultants of Atlanta
Suwanee, Georgia, 30024
Allergy Asthma and Immunology Center P.C.
Tulsa, Oklahoma, 74136
Central States Research, LLC
Tulsa, Oklahoma, 74136
About this study
Official title: A Phase 2, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Investigate Etokimab (ANB020) in Adult Subjects With Chronic Rhinosinusitis With Nasal Polyposis
A study to evaluate the safety and efficacy of multiple doses of etokimab in adults with chronic rhinosinusitis with nasal polyps.
Read the detailed description
This study is a randomized, placebo controlled, double-blind, multi-dose study to assess the efficacy of two different dose regimens of etokimab compared to placebo in adults with moderate-to-severe chronic sinusitis with nasal polyposis (CRSwNP).
During the screening period, all subjects will undergo evaluation for eligibility. A centralized reader will be used to confirm the diagnosis of CRSwNP as assessed by nasal endoscopy, computed tomography (CT) scan of sinuses, and symptom scoring to reduce the risk of interpretation variation.
Participants will also be provided mometasone furoate nasal spray (MFNS) for use during the trial and are required to undergo a minimum run-in period of 20 days prior to Day 1 with approximately 80% compliance.
Participants will be randomly assigned on Day 1 to one of the three treatment arms in a 1:1:1 ratio.
- Conditions
- Chronic Rhinosinusitis
- Being tested
- Etokimab, Placebo, Mometasone Furoate Nasal Spray
- Keywords
- ANB020, Etokimab, CRSwNP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtokimabBiological
Also called ANB020
Administered by subcutaneous injection
PlaceboBiological
Administered by subcutaneous injection
Mometasone Furoate Nasal SprayDrug
Mometasone Furoate Nasal Spray (MFNS) was used from 4 weeks prior to Day 1 (Run-in period) through the end of the study. Participants used 2 actuations (50 μg/actuation) in each nostril BID, total daily dose of 400 μg. Participants intolerant to BID intranasal corticosteroids (INCS) could use the lower dose regimen of 1 actuation in each nostril BID, total daily dose of 200 μg.
| Study group | Role | What they receive |
|---|---|---|
| Etokimab 300 mg + 150 mg Q4W | Experimental | Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then 150 mg etokimab by subcutaneous injection every 4 weeks (Q4W) up to Week 12 (Weeks 4, 8, and 12). Participants also used mometasone furoate nasal spray (MFNS) of 2 actuations (50 μg/actuation) in each nostril twice daily (BID). Receives: Biological: Etokimab; Drug: Mometasone Furoate Nasal Spray |
| Etokimab 300 mg + 150 mg Q8W | Experimental | Participants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then etokimab 150 mg by subcutaneous injection every 8 weeks (Q8W) up to Week 12 and placebo at Weeks 4 and 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. Receives: Biological: Etokimab; Biological: Placebo; Drug: Mometasone Furoate Nasal Spray |
| Placebo | Placebo comparator | Participants received placebo subcutaneous injection once every 4 weeks up to Week 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. Receives: Biological: Placebo; Drug: Mometasone Furoate Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Nasal Polyp Score (NPS) to Week 16
Nasal polyps were evaluated by nasal endoscopy using centralized imaging data assessments scored by an independent reviewer.
Each nostril was scored on a scale from 0 to 4, where a score of 0 means no polyps, and a score of 4 means the presence of polyps causing complete obstruction of the inferior nasal cavity.
The bilateral NPS score is the sum of the right and left nostril scores, and hence the total NPS value is between 0 and 8 (worst). A negative change from Baseline indicates improvement.
Measured: Baseline and Week 16
Change From Baseline in Sino-Nasal Outcome Test-22 (SNOT-22) Score at Week 16
SNOT-22 is a 22-item outcome measure on a 5-category scale that assesses symptoms and social/emotional consequences of rhinosinusitis. Each item is scored from 0 (No problem at all) to 5 (Problem as bad as it can be), and the total score ranges from 0 to 110. Higher SNOT-22 scores are indicative of greater impact of rhinosinusitis on quality of life. A negative change from Baseline indicates improvement.
Measured: Baseline and Week 16
Secondary outcomes (1)
Change From Baseline in Eosinophil Count
Measured: Baseline, Week 16, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start29 Nov 2018
- Primary completion2 Sep 2020
- Study completion26 Oct 2020
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.
- Other trials for Chronic RhinosinusitisStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnaptysBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SM_ANB020-006@syneoshealth.com, Study director, AnaptysBio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614923
- Sponsor's protocol ID
- ANB020-006
- Status last verified
- Aug 2021
- First submitted
- 27 Jul 2018
- Last updated
- 24 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Investigate Etokimab (ANB020) in Adult Subjects With Chronic Rhinosinusitis With Nasal Polyposis
- ClinicalTrials.gov ID
- NCT03614923
- Acronym / sponsor ID
- ANB020-006
- Conditions
- Chronic Rhinosinusitis
- Keywords
- ANB020, Etokimab, CRSwNP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- AnaptysBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Posted 24 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the safety and efficacy of multiple doses of etokimab in adults with chronic rhinosinusitis with nasal polyps.
Detailed description
This study is a randomized, placebo controlled, double-blind, multi-dose study to assess the efficacy of two different dose regimens of etokimab compared to placebo in adults with moderate-to-severe chronic sinusitis with nasal polyposis (CRSwNP).
During the screening period, all subjects will undergo evaluation for eligibility. A centralized reader will be used to confirm the diagnosis of CRSwNP as assessed by nasal endoscopy, computed tomography (CT) scan of sinuses, and symptom scoring to reduce the risk of interpretation variation.
Participants will also be provided mometasone furoate nasal spray (MFNS) for use during the trial and are required to undergo a minimum run-in period of 20 days prior to Day 1 with approximately 80% compliance.
Participants will be randomly assigned on Day 1 to one of the three treatment arms in a 1:1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Etokimab 300 mg + 150 mg Q4W | Experimental | Biological: Etokimab, Drug: Mometasone Furoate Nasal SprayParticipants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then 150 mg etokimab by subcutaneous injection every 4 weeks (Q4W) up to Week 12 (Weeks 4, 8, and 12). Participants also used mometasone furoate nasal spray (MFNS) of 2 actuations (50 μg/actuation) in each nostril twice daily (BID). |
| Etokimab 300 mg + 150 mg Q8W | Experimental | Biological: Etokimab, Biological: Placebo, Drug: Mometasone Furoate Nasal SprayParticipants received a 300 mg loading dose of etokimab administered by subcutaneous injection at Week 0 then etokimab 150 mg by subcutaneous injection every 8 weeks (Q8W) up to Week 12 and placebo at Weeks 4 and 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. |
| Placebo | Placebo comparator | Biological: Placebo, Drug: Mometasone Furoate Nasal SprayParticipants received placebo subcutaneous injection once every 4 weeks up to Week 12. Participants also used MFNS of 2 actuations (50 μg/actuation) in each nostril BID. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinically confirmed diagnosis of CRSwNP
- Nasal polyp score (NPS) ≥ 4 out of a maximum score for both nostrils (with at least a score of 1 for each nostril).
- 22 Item Sino-Nasal Outcome Test (SNOT-22) score > 15.
- Presence of at least two of the following symptoms prior to screening: nasal blockade/obstruction/congestion or nasal discharge (anterior/posterior nasal drip); facial pain/pressure; reduction or loss of smell
- Body mass index (BMI) of 18 to 42 kg/m^2 (inclusive) and total body weight > 50 kg (110 lb). BMI=weight (kg)/(height [m^2]).
Key exclusion criteria (7 listed)
- Use of investigational drugs or prohibited therapy for this study within 8 weeks before screening or 5 half-lives, whichever is longer.
- Have experienced severe life threatening anaphylactic reactions.
- Participation in any interventional study for the treatment of CRSwNP in the 3 months before screening.
- If female, is pregnant or lactating, or intend to become pregnant during the study period.
- History (or suspected history) of alcohol or substance abuse.
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 by subcutaneous injection | Biological | Etokimab 300 mg + 150 mg Q4W, Etokimab 300 mg + 150 mg Q8W |
| PlaceboAdministered by subcutaneous injection | Biological | Etokimab 300 mg + 150 mg Q8W, Placebo |
| Mometasone Furoate Nasal SprayMometasone Furoate Nasal Spray (MFNS) was used from 4 weeks prior to Day 1 (Run-in period) through the end of the study. Participants used 2 actuations (50 μg/actuation) in each nostril BID, total daily dose of 400 μg. Participants intolerant to BID intranasal corticosteroids (INCS) could use the lower dose regimen of 1 actuation in each nostril BID, total daily dose of 200 μg. | Drug | Etokimab 300 mg + 150 mg Q4W, Etokimab 300 mg + 150 mg Q8W, Placebo |
Primary outcome
Change From Baseline in Nasal Polyp Score (NPS) to Week 16
Time frame: Baseline and Week 16
Nasal polyps were evaluated by nasal endoscopy using centralized imaging data assessments scored by an independent reviewer. Each nostril was scored on a scale from 0 to 4, where a score of 0 means no polyps, and a score of 4 means the presence of polyps causing complete obstruction of the inferior nasal cavity. The bilateral NPS score is the sum of the right and left nostril scores, and hence the total NPS value is between 0 and 8 (worst). A negative change from Baseline indicates improvement.
Change From Baseline in Sino-Nasal Outcome Test-22 (SNOT-22) Score at Week 16
Time frame: Baseline and Week 16
SNOT-22 is a 22-item outcome measure on a 5-category scale that assesses symptoms and social/emotional consequences of rhinosinusitis. Each item is scored from 0 (No problem at all) to 5 (Problem as bad as it can be), and the total score ranges from 0 to 110. Higher SNOT-22 scores are indicative of greater impact of rhinosinusitis on quality of life. A negative change from Baseline indicates improvement.
1 secondary outcome
Change From Baseline in Eosinophil Count
Time frame: Baseline, Week 16, and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
SM_ANB020-006@syneoshealth.com study director
AnaptysBio, Inc.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etokimab and Mometasone Furoate Nasal Spray in people with Chronic Rhinosinusitis, run by AnaptysBio, Inc. at 28 sites in United States.
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 5 inclusion and 7 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 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. 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 24 Jan 2022). 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 Nasal Polyp Score (NPS) to Week 16 (time frame: Baseline and Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2022.