A Phase 2 interventional study of Etokimab and Placebo in Chronic Rhinosinusitis, sponsored by AnaptysBio, Inc.. Completed at 28 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-01-24.
Sponsored by AnaptysBio, Inc. · Phase 2, Interventional, and Treatment
A study to evaluate the safety and efficacy of multiple doses of etokimab in adults with chronic rhinosinusitis with nasal polyps.
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.
330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.
This study's enrollment of 105 is above the median of 60 across 227 interventional studies indexed under Rhinosinusitis.
Browse Rhinosinusitis studies →AnaptysBio, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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).
Biological: Etokimab · Drug: Mometasone Furoate Nasal Spray
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.
Biological: Etokimab · Biological: Placebo · Drug: Mometasone Furoate Nasal Spray
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.
Biological: Placebo · Drug: Mometasone Furoate Nasal Spray
Administered by subcutaneous injection
Also known as: ANB020
Administered by subcutaneous injection
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.
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.
Time frame: 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.
Time frame: Baseline and Week 16
Change From Baseline in Eosinophil Count
Time frame: Baseline, Week 16, and Week 24
This study was conducted at 26 sites in the United States.
| Milestone | Etokimab 300 mg + 150 mg Q4W | Etokimab 300 mg + 150 mg Q8W | Placebo |
|---|---|---|---|
| Started | 35 | 35 | 35 |
| Completed | 30 | 30 | 30 |
| Not completed | 5 | 5 | 5 |
| Withdrew: Withdrawal by subject | 2 | 1 | 1 |
| Withdrew: Adverse event | 0 | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 | 1 |
| Withdrew: Lack of efficacy | 2 | 0 | 1 |
| Withdrew: Non-compliance | 0 | 1 | 0 |
| Withdrew: Other | 0 | 1 | 1 |
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.
| score on a scale | Etokimab 300 mg + 150 mg Q4W | Etokimab 300 mg + 150 mg Q8W | Placebo |
|---|---|---|---|
| Change From Baseline in Nasal Polyp Score (NPS) to Week 16 | -0.87 ± 0.225 | -0.89 ± 0.221 | -0.49 ± 0.225 |
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.
| score on a scale | Etokimab 300 mg + 150 mg Q4W | Etokimab 300 mg + 150 mg Q8W | Placebo |
|---|---|---|---|
| Change From Baseline in Sino-Nasal Outcome Test-22 (SNOT-22) Score at Week 16 | -22.97 ± 3.084 | -18.34 ± 3.077 | -16.32 ± 3.112 |
| 10^9 cells/L | Etokimab 300 mg + 150 mg Q4W | Etokimab 300 mg + 150 mg Q8W | Placebo |
|---|---|---|---|
| Baseline | 0.437 ± 0.2546 | 0.350 ± 0.2038 | 0.434 ± 0.2490 |
| Change from Baseline at Week 16 | -0.162 ± 0.1717 | -0.117 ± 0.1718 | -0.020 ± 0.1843 |
| Change from Baseline at Week 24 | -0.038 ± 0.2451 | -0.029 ± 0.1674 | 0.019 ± 0.2151 |
Collected over From first dose of study medication on Day 1 until Week 16, or up to 28 days after the last dose of study medication for participants who discontinued treatment earlier than Week 16.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Etokimab 300 mg + 150 mg Q4W | 0/35 (0%) | 2/35 (5.7%) | 8/35 (22.9%) |
| Etokimab 300 mg + 150 mg Q8W | 0/35 (0%) | 0/35 (0%) | 8/35 (22.9%) |
| Placebo | 0/35 (0%) | 0/35 (0%) | 6/35 (17.1%) |
| Event | Etokimab 300 mg + 150 mg Q4W | Etokimab 300 mg + 150 mg Q8W | Placebo |
|---|---|---|---|
| Urinary tract infectionInfections and infestations | 1/35 | 0/35 | 0/35 |
| HydronephrosisRenal and urinary disorders | 1/35 | 0/35 | 0/35 |
| UreterolithiasisRenal and urinary disorders | 1/35 | 0/35 | 0/35 |
| Pneumonia aspirationRespiratory, thoracic and mediastinal disorders | 1/35 | 0/35 | 0/35 |
| Event | Etokimab 300 mg + 150 mg Q4W | Etokimab 300 mg + 150 mg Q8W | Placebo |
|---|---|---|---|
| SinusitisInfections and infestations | 2/35 | 5/35 | 4/35 |
| HeadacheNervous system disorders | 1/35 | 3/35 | 1/35 |
| Upper respiratory tract infectionInfections and infestations | 2/35 | 1/35 | 1/35 |
| Injection site erythemaGeneral disorders | 2/35 | 1/35 | 0/35 |
| HypertensionVascular disorders | 2/35 | 0/35 | 0/35 |
| Age, Continuous(years) | Etokimab 300 mg + 150 mg Q4W | Etokimab 300 mg + 150 mg Q8W | Placebo | Total |
|---|---|---|---|---|
| Mean | 49.1 ± 14.82 | 48.2 ± 10.28 | 49.5 ± 12.68 | 49.0 ± 12.62 |
| Age, Customized(Participants) | Etokimab 300 mg + 150 mg Q4W | Etokimab 300 mg + 150 mg Q8W | Placebo | Total |
|---|---|---|---|---|
| <65 years | 32 | 35 | 31 | 98 |
| >=65 years | 3 | 0 | 4 | 7 |
| Sex: Female, Male(Participants) | Etokimab 300 mg + 150 mg Q4W | Etokimab 300 mg + 150 mg Q8W | Placebo | Total |
|---|---|---|---|---|
| Female | 8 | 12 | 9 | 29 |
| Male | 27 | 23 | 26 | 76 |
| Ethnicity (NIH/OMB)(Participants) | Etokimab 300 mg + 150 mg Q4W | Etokimab 300 mg + 150 mg Q8W | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 6 | 2 | 5 | 13 |
| Not Hispanic or Latino | 29 | 33 | 30 | 92 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Etokimab 300 mg + 150 mg Q4W | Etokimab 300 mg + 150 mg Q8W | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 5 | 5 | 12 |
| White | 33 | 29 | 30 | 92 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Nasal Polyp Score (NPS)(score on a scale) | Etokimab 300 mg + 150 mg Q4W | Etokimab 300 mg + 150 mg Q8W | Placebo | Total |
|---|---|---|---|---|
| Mean | 5.4 ± 1.58 | 5.2 ± 2.01 | 5.7 ± 1.86 | 5.4 ± 1.83 |
| Sino-Nasal Outcome Test (SNOT-22) Score(score on a scale) | Etokimab 300 mg + 150 mg Q4W | Etokimab 300 mg + 150 mg Q8W | Placebo | Total |
|---|---|---|---|---|
| Mean | 51.4 ± 19.73 | 53.9 ± 23.67 | 56.9 ± 21.69 | 54.1 ± 21.78 |
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AnaptysBio, Inc.