Trial · NCT05281523
Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2)
NCT05281523, Phase 3, Completed, GlaxoSmithKline; results first posted 2025-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2). Trials, record NCT05281523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05281523
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2)
- NCT number
- NCT05281523
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 264 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Nasal Polyps
- Interventions
- Depemokimab (GSK3511294), Placebo
- First posted
- 2022-03-16
- Last updated
- 2025-09-09
- Other registries' IDs
- eudract:2021-005055-36
- Results first posted
- 2025-09-09
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 (Centrally Read) | Baseline (Day 1) and at Week 52 | Total endoscopic nasal polyps (NP) score evaluated the size and extent of nasal polyps via endoscopy. The assessments were performed by central video image recordings of nasal endoscopy. The right and left nostrils were scored from 0 to 4 (0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction of the inferior meatus). The scores were graded based on NP size, recorded as sum of the right and left nostril scores and ranges from 0 (no polyps) to 8 (large polyps), calculated by summing the scores \[0 to 4\] in each nostril; with higher scores indicating worse status. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value. |
| Primary | Change From Baseline in Mean Nasal Obstruction Score Using Verbal Response Scale From Weeks 49 Through to Week 52 | Baseline (Day 1) and from Week 49 to Week 52 | This endpoint evaluated the change from baseline in the mean nasal obstruction score using a Verbal Response Scale (VRS) from Week 49 through to Week 52. Participants used a VRS to rate nasal obstruction severity, with scores averaged over the specified period to assess treatment impact on nasal obstruction symptoms. Participants were asked to indicate the severity of nasal obstruction at their worst over the last 24 hours using a 4-point VRS, with options of no symptoms, mild symptoms, moderate symptoms, and severe symptoms. This was scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms), with higher scores indicating worse status. Baseline was defined as the average score from 28 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value. |
| Secondary | Change From Baseline in Mean Symptom Score for Rhinorrhea (Runny Nose) Using Verbal Response Scale From Week 49 Through to Week 52 | Baseline (Day 1) and from Week 49 to Week 52 | Participants were asked to indicate the severity of rhinorrhea (runny nose) at their worst over the last 24 hours using a 4-point VRS, with options of no symptoms, mild symptoms, moderate symptoms, and severe symptoms. This was scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms). Higher scores indicated worst status. The average of daily scores in 4-weekly intervals were calculated and change from baseline data are presented for Weeks 49-52. Baseline was defined as the average score from 28 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value. |
| Secondary | Change From Baseline in Mean Symptom Score for Loss of Smell From Week 49 Through to Week 52 | Baseline (Day 1) and from Week 49 to Week 52 | Participants were asked to indicate the severity of loss of smell at their worst over the last 24 hours using a 4-point VRS, with options of no symptoms, mild symptoms, moderate symptoms, and severe symptoms. This was scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms). Higher score indicates worse status. The average of daily scores in 4-weekly intervals were calculated and change from baseline data are presented for Weeks 49-52. Baseline was defined as the average score from 28 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value. |
| Secondary | Change From Baseline in Lund Mackay (LMK) Computed Tomography (CT) Score at Week 52 | Baseline (Day 1) and at Week 52 | The LMK CT scoring system is based on CT imaging of the sinuses with points given for degree of opacification: 0 =normal, 1 = partial opacification, 2 = total opacification. These points were applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side (right and left). The osteomeatal complex (OC) is graded as 0 = not occluded, or 2 = occluded. The range for the total LMK CT score is therefore 0 (normal) to 24 (total opacification) when summed across both sides with higher scores indicating more severe disease. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value. |
| Secondary | Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52 | Baseline (Day 1) and at Week 52 | Sino-nasal outcome test-22 is a 22-item measure of disease specific health related quality of life (HRQoL). Participants were asked to rate the severity of their condition on each of the 22 items over the previous 2 weeks using a 6-point rating scale of 0-5 including: 0 = Not present/no problem; 1 = Very mild problem; 2 = Mild or slight problem; 3 = Moderate problem; 4 = Severe problem; 5 = Problem as "bad as it can be". The scores for each question were summed up to derive the total score range for the SNOT-22 was from 0 (high quality of life) to 110 (worst quality of life), where higher scores indicate worse quality of life. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value. |
| Secondary | Change From Baseline in Mean Nasal Obstruction Score From Week 21 Through to Week 24 | Baseline (Day 1) and from Week 21 to Week 24 | Participants were asked to indicate the severity of nasal obstruction at its worst over the previous 24 hours using a 4-point VRS. The response options were no symptoms, mild symptoms, moderate symptoms, and severe symptoms, scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms). Higher scores indicate more severe status. The average of daily scores in 4-weekly intervals were calculated and change from baseline data are presented for Weeks 21-24. Baseline was defined as the average score from 28 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value. |
| Secondary | Change From Baseline in Total Endoscopic Nasal Polyps Score at Week 26 | Baseline (Day 1) and at Week 26 | Total endoscopic nasal polyps (NP) score evaluated the size and extent of nasal polyps via endoscopy. The assessments were performed by central video image recordings of nasal endoscopy. The right and left nostrils were scored from 0 to 4 (0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction of the inferior meatus). The scores were graded based on NP size, recorded as sum of the right and left nostril scores and ranges from 0 (no polyps) to 8 (large polyps), calculated by summing the scores \[0 to 4\] in each nostril; with higher scores indicating worse status. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value. |
| Secondary | Percentage of Participants Requiring First Nasal Surgery (Actual or Entry on Waiting List) or Disease-Modulating Medication for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Up to Week 52 | Up to Week 52 | Nasal polyp surgery is defined as any procedure involving instruments resulting in incision and removal of tissue from the nasal cavity (for example polypectomy). Time to first nasal polyp surgery (actual or entry on waiting list) or disease-modulating medication for CRSwNP up to Week 52 was assessed in a pre-specified pooled analysis across replicate studies 217095 (NCT05274750) and 218079 (NCT05281523). The percentage of participants with nasal surgery or disease-modulating medication for CRSwNP and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method. |
| Secondary | Percentage of Participants Requiring First Nasal Surgery (Actual) or Disease-Modulating Medication for CRSwNP up to Week 52 | Up to Week 52 | Nasal polyp surgery is defined as any procedure involving instruments resulting in incision and removal of tissue from the nasal cavity (for example polypectomy).Time to first nasal polyp surgery (actual) or disease-modulating medication for CRSwNP up to week 52 was assessed in a pre-specified pooled analysis across replicate studies 217095 (NCT05274750) and 218079 (NCT05281523). The percentage of participants with nasal surgery or disease-modulating medication for CRSwNP and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 (Centrally Read) | Baseline (Day 1) and at Week 52 | Full analysis set population included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites due to GCP violation. The overall number of participants analyzed represents only those participants available at the specified time points and evaluable for this outcome measure. | Scores on scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Mean Nasal Obstruction Score Using Verbal Response Scale From Weeks 49 Through to Week 52 | Baseline (Day 1) and from Week 49 to Week 52 | Full analysis set population included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. The overall number of participants analyzed represents only those participants available at the specified time points and evaluable for this outcome measure. | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Symptom Score for Rhinorrhea (Runny Nose) Using Verbal Response Scale From Week 49 Through to Week 52 | Baseline (Day 1) and from Week 49 to Week 52 | Full analysis set population included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. The overall number of participants analyzed represents only those participants available at the specified time points and evaluable for this outcome measure. | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Symptom Score for Loss of Smell From Week 49 Through to Week 52 | Baseline (Day 1) and from Week 49 to Week 52 | Full analysis set population included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. The overall number of participants analyzed represents only those participants available at the specified time points and evaluable for this outcome measure. | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Lund Mackay (LMK) Computed Tomography (CT) Score at Week 52 | Baseline (Day 1) and at Week 52 | Full analysis set population included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. The overall number of participants analyzed represents only those participants available at the specified time points and evaluable for this outcome measure. | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52 | Baseline (Day 1) and at Week 52 | Full analysis set population included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. The overall number of participants analyzed represents only those participants available at the specified time points and evaluable for this outcome measure. | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Nasal Obstruction Score From Week 21 Through to Week 24 | Baseline (Day 1) and from Week 21 to Week 24 | Full analysis set population included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. The overall number of participants analyzed represents only those participants available at the specified time points and evaluable for this outcome measure. | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total Endoscopic Nasal Polyps Score at Week 26 | Baseline (Day 1) and at Week 26 | Full analysis set population included all randomized participants who received at least 1 dose of study treatment excluding participants from 2 sites with GCP violation. The overall number of participants analyzed represents only those participants available at the specified time points and evaluable for this outcome measure. | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Requiring First Nasal Surgery (Actual or Entry on Waiting List) or Disease-Modulating Medication for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Up to Week 52 | Up to Week 52 | For pooled studies of 217095 (NCT05274750) and 218079 (NCT05281523), the analysis was performed on the FAS population. The FAS included all randomized participants who received at least 1 dose of study treatment excluding participants from 1 site for 217095 and 2 sites for 218079 respectively with GCP violation. Participants were analyzed according to the treatment they were allocated at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Requiring First Nasal Surgery (Actual) or Disease-Modulating Medication for CRSwNP up to Week 52 | Up to Week 52 | For pooled studies of 217095 (NCT05274750) and 218079 (NCT05281523), the analysis was performed on the FAS population. The FAS included all randomized participants who took at least 1 dose of study treatment excluding participants from 1 site for 217095 and 2 sites for 218079 respectively with GCP violation. Participants were analyzed according to the treatment they were allocated at randomization. | Percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 (Centrally Read) | Depemokimab | -0.5 | Standard Error 0.14 | Scores on scale | |
| Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 (Centrally Read) | Placebo | 0.1 | Standard Error 0.15 | Scores on scale | |
| Change From Baseline in Mean Nasal Obstruction Score Using Verbal Response Scale From Weeks 49 Through to Week 52 | Depemokimab | -0.77 | Standard Error 0.076 | Scores on scale | |
| Change From Baseline in Mean Nasal Obstruction Score Using Verbal Response Scale From Weeks 49 Through to Week 52 | Placebo | -0.53 | Standard Error 0.078 | Scores on scale | |
| Change From Baseline in Mean Symptom Score for Rhinorrhea (Runny Nose) Using Verbal Response Scale From Week 49 Through to Week 52 | Depemokimab | -0.72 | Standard Error 0.080 | Scores on scale | |
| Change From Baseline in Mean Symptom Score for Rhinorrhea (Runny Nose) Using Verbal Response Scale From Week 49 Through to Week 52 | Placebo | -0.54 | Standard Error 0.082 | Scores on scale | |
| Change From Baseline in Mean Symptom Score for Loss of Smell From Week 49 Through to Week 52 | Depemokimab | -0.56 | Standard Error 0.066 | Scores on scale | |
| Change From Baseline in Mean Symptom Score for Loss of Smell From Week 49 Through to Week 52 | Placebo | -0.30 | Standard Error 0.068 | Scores on scale | |
| Change From Baseline in Lund Mackay (LMK) Computed Tomography (CT) Score at Week 52 | Depemokimab | -3.5 | Standard Error 0.42 | Scores on scale | |
| Change From Baseline in Lund Mackay (LMK) Computed Tomography (CT) Score at Week 52 | Placebo | -0.3 | Standard Error 0.44 | Scores on scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Depemokimab | 132 | |
| Overall Study | STARTED | Placebo | 132 | |
| Overall Study | Full Analysis Population | Depemokimab | 129 | |
| Overall Study | Full Analysis Population | Placebo | 128 | |
| Overall Study | COMPLETED | Depemokimab | 122 | |
| Overall Study | COMPLETED | Placebo | 111 | |
| Overall Study | NOT COMPLETED | Depemokimab | 10 | |
| Overall Study | NOT COMPLETED | Placebo | 21 |
Source ClinicalTrials.gov
Adverse events74
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Depemokimab | 6 | 129 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 128 | 2 |
| other | COVID-19 | Infections and infestations | Depemokimab | 9 | 129 | 9 |
| other | COVID-19 | Infections and infestations | Placebo | 11 | 128 | 11 |
| other | Influenza | Infections and infestations | Depemokimab | 3 | 129 | 3 |
| other | Influenza | Infections and infestations | Placebo | 5 | 128 | 5 |
| other | Nasopharyngitis | Infections and infestations | Depemokimab | 28 | 129 | 39 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 15 | 128 | 22 |
| other | Pharyngitis | Infections and infestations | Depemokimab | 4 | 129 | 4 |
| other | Pharyngitis | Infections and infestations | Placebo | 5 | 128 | 5 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Depemokimab | 0 | 129 |
| Total, all-cause mortality | Placebo | 0 | 128 |
| Total, other adverse events | Depemokimab | 75 | 129 |
| Total, other adverse events | Placebo | 78 | 128 |
| Total, serious adverse events | Depemokimab | 6 | 129 |
| Total, serious adverse events | Placebo | 10 | 128 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Depemokimab vs Placebo: deaths from any cause | Trial comparisons |
| Depemokimab vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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