Efficacy and Safety of Depemokimab (GSK3511294) in Partic... | NCT05281523

NCT05281523

ID	Type	Description	Link
2021-005055-36	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Depemokimab	Experimental	Participants received a 100 milligram (mg) dose of depemokimab subcutaneous (SC) injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance Chronic rhinosinusitis with nasal polyps (CRSwNP) standard of care (SOC) treatment throughout the study.	Biological: Depemokimab (GSK3511294)
Placebo	Placebo Comparator	Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Depemokimab (GSK3511294)	Biological	Depemokimab (GSK3511294) was administered using a pre-filled syringe.	Depemokimab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 (Centrally Read)	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.	Baseline (Day 1) and at Week 52
Change From Baseline in Mean Nasal Obstruction Score Using Verbal Response Scale From Weeks 49 Through 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.	Baseline (Day 1) and from Week 49 to Week 52

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Mean Symptom Score for Rhinorrhea (Runny Nose) Using Verbal Response Scale From Week 49 Through 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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants with 18 years of age and older inclusive, at the time of signing the informed consent.
Endoscopic bilateral NP score of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity) assessed by the investigator.
Participants who have had at least one of the following at Visit 1: Previous nasal surgery for the removal of NP; Have used at least three consecutive days of systemic corticosteroids in the previous 2 years for the treatment of NP; Medically unsuitable or intolerant to systemic corticosteroid.
Participants (except for those in Japan) must be on daily treatment with intranasal corticosteroids (INCS) (including intranasal liquid steroid wash/douching) for at least 8 weeks prior to screening.
Participants presenting with severe NP symptoms defined as symptoms of nasal congestion/blockade/obstruction with moderate or severe severity and loss of smell or rhinorrhea (runny nose) based on clinical assessment by the investigator.
Presence of symptoms of chronic rhinosinusitis as described by at least 2 different symptoms for at least 12 weeks prior to Visit 1, one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip), plus facial pain/pressure and/or reduction or loss of smell.
Male or eligible female participants

Exclusion Criteria:

As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study.
Cystic fibrosis.
Antrochoanal polyps.
Nasal cavity tumor (malignant or benign)
Fungal rhinosinusitis
Severe nasal septal deviation occluding one nostril preventing full assessment of nasal polyps in both nostrils.
Participants who had a sino-nasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of nasal polyp score.
Acute sinusitis or upper respiratory tract infection (URTI) at screening or in 2 weeks prior to screening.
Ongoing rhinitis medicamentosa (rebound or chemical induced rhinitis).
Participants who have had an asthma exacerbation requiring admission to hospital within 4 weeks of Screening.
Participants who have undergone any intranasal and/or sinus surgery (for example polypectomy, balloon dilatation or nasal stent insertion) within 6 months prior to Visit 1; nasal biopsy prior to Visit 1 for diagnostic purposes only is excepted.
Participants where NP surgery is contraindicated in the opinion of the Investigator.
Participants with other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndromes including (but not limited to) eosinophilic granulomatosis with polyangiitis (EGPA) (formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis.
Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1.
A known immunodeficiency (e.g. human immunodeficiency virus (HIV), other than that explained by the use of corticosteroids (CSs) taken as therapy for asthma.
A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.
Liver Disease: Alanine aminotransferase (ALT) >2 times upper limit normal (ULN); Total bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin less than [<]35 percent [%]); Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological or any other system abnormalities that are uncontrolled with standard treatment.
Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis must be excluded prior to enrollment.
Hypersensitivity: Participants with allergy/intolerance to the excipients of depemokimab (GSK3511294) in a monoclonal antibody, or biologic.
Participants that, according to the investigator's medical judgment, are likely to have active Coronavirus disease-2019 (COVID-19) infection must be excluded. Participants with known COVID-19 positive contacts within the past 14 days must be excluded for at least 14 days following the exposure during which the participant should remain symptom-free. Reported smell/ taste complications from COVID-19 must be used as exclusion.
Participants that have been exposed to ionising radiation in excess of 10 millisievert (mSv) above background over the previous 3-year period as a result of occupational exposure or previous participation in research studies.
Previously participated in any study with mepolizumab, reslizumab, or benralizumab and received study intervention (including placebo) within 12 months prior to Visit 1.
Women who are pregnant or lactating or are planning on becoming pregnant during the study.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Tucson	Arizona	85724	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation
	Background	Gevaert P, Cornet M, Mullol J, De Corso E, Keles Turel N, Desrosiers M, et al. . ANCHOR-1/-2 primary data including pooled analysis ms. Lancet. PMID: 40037388 DOI: 10.1016/S0140-6736(25)00197-7
41461999	Derived	Jackson DJ, Bourdin A, Blackorby A, Leslie A, Vichiendilokkul A, Howarth P, Karkoszka N, Fujieda S, Cornet M. Safety and Tolerability of Twice-Yearly Depemokimab in Patients with Asthma and Chronic Rhinosinusitis with Nasal Polyps: Pooled Results from SWIFT-1/-2 and ANCHOR-1/-2. Adv Ther. 2026 Feb;43(2):880-897. doi: 10.1007/s12325-025-03457-4. Epub 2025 Dec 29.
40037388

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Depemokimab	Participants received a 100 milligram (mg) dose of depemokimab subcutaneous (SC) injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance Chronic rhinosinusitis with nasal polyps (CRSwNP) standard of care (SOC) treatment throughout the study.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 26, 2024	Jul 9, 2025

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

FG000132 subjects
FG001132 subjects

The full analysis set population included all randomized participants who received at least one dose of study intervention excluding participants from 2 sites with GCP violation. Participants were analyzed according to the intervention they were allocated at randomization.

Arm/Group Information

ID	Title	Description
BG000	Depemokimab	Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
BG001	Placebo	Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

YEARS

Title

Denominators

Categories

Title	Measurements
	BG00050.5± 12.95 BG00150.4± 12.98 BG00250.4± 12.94

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00040 BG00140 BG002

Race/Ethnicity, Customized

"All Other Races" category (American Indian or Alaska Native and Black or African American where 0\

Count of Participants

Participants

Title

Denominators

Categories

ASIAN

Title	Measurements
	BG00027 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 (Centrally Read)

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.

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.

Posted

Least Squares Mean

Standard Error

Scores on scale

Baseline (Day 1) and at Week 52

ID	Title	Description
OG000	Depemokimab	Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
OG001	Placebo	Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.

Units	Counts
Participants	OG000129 OG001128

Title

Denominators

Categories

Title	Measurements
	OG000-0.5± 0.14 OG0010.1± 0.15

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP	Mixed Models Analysis		0.004		Difference in Least Square Means	-0.6			2-Sided	95	-1.0	-0.2					Other	Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group.

Primary

Change From Baseline in Mean Nasal Obstruction Score Using Verbal Response Scale From Weeks 49 Through 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.

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.

Posted

Least Squares Mean

Standard Error

Scores on scale

Baseline (Day 1) and from Week 49 to Week 52

ID	Title	Description
OG000	Depemokimab	Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.

Secondary

Change From Baseline in Mean Symptom Score for Rhinorrhea (Runny Nose) Using Verbal Response Scale From Week 49 Through 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.

Posted

Least Squares Mean

Standard Error

Scores on scale

Baseline (Day 1) and from Week 49 to Week 52

ID	Title	Description
OG000	Depemokimab	Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
OG001	Placebo

Secondary

Change From Baseline in Mean Symptom Score for Loss of Smell From Week 49 Through 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.

Posted

Least Squares Mean

Standard Error

Scores on scale

Baseline (Day 1) and from Week 49 to Week 52

ID	Title	Description
OG000	Depemokimab	Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
OG001	Placebo

Secondary

Change From Baseline in Lund Mackay (LMK) Computed Tomography (CT) Score 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.

Posted

Least Squares Mean

Standard Error

Scores on scale

Baseline (Day 1) and at Week 52

ID	Title	Description
OG000	Depemokimab	Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
OG001	Placebo

Secondary

Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score 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.

Posted

Least Squares Mean

Standard Error

Scores on scale

Baseline (Day 1) and at Week 52

ID	Title	Description
OG000	Depemokimab	Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
OG001	Placebo

Secondary

Change From Baseline in Mean Nasal Obstruction Score From Week 21 Through 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.

Posted

Least Squares Mean

Standard Error

Scores on scale

Baseline (Day 1) and from Week 21 to Week 24

ID	Title	Description
OG000	Depemokimab	Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
OG001	Placebo

Secondary

Change From Baseline in Total Endoscopic Nasal Polyps Score at Week 26

Posted

Least Squares Mean

Standard Error

Scores on scale

Baseline (Day 1) and at Week 26

ID	Title	Description
OG000	Depemokimab	Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.

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

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.

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.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to Week 52

ID	Title	Description
OG000	Pooled Depemokimab	This reporting arm contains the pooled population of treated participants from the clinical trial groups "depemokimab" study intervention from protocol 217095 and protocol 218079. Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.

Secondary

Percentage of Participants Requiring First Nasal Surgery (Actual) or Disease-Modulating Medication for CRSwNP 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.

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.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to Week 52

ID	Title	Description
OG000	Pooled Depemokimab	This reporting arm contains the pooled population of treated participants from the clinical trial groups "Depemokimab" study intervention from protocol 217095 and protocol 218079. Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.

Secondary

Percentage of Participants Requiring at Least One Course of Systemic Corticosteroids or Disease-Modulating Medication for CRSwNP or Nasal Surgery (Actual) During the Week 52 Treatment Period

The percentage of participants requiring at least 1 course of systemic corticosteroids or disease-modulating medication for CRSwNP or nasal surgery (actual) during the Week 52 treatment period was assessed in a pre-specified pooled analysis across replicate studies 217095 (NCT05274750) and 218079 (NCT05281523). Percentage of participants with nasal surgery or course of systemic CS for CRSwNP and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method.

Posted

Number

Percentage of participants

Up to Week 52

ID	Title	Description
OG000	Pooled Depemokimab	This reporting arm contains the pooled population of treated participants from the clinical trial groups "Depemokimab" study intervention from protocol 217095 and protocol 218079. Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.
OG001

Secondary

Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 52

The ACQ-5 is a five-item questionnaire designed to be self-completed by the participants to assess the most common asthma symptoms. The 5 questions enquired to recall how their asthma had been during the previous week and to respond about the frequency and/or severity of symptoms (nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheezing). The overall ACQ-5 response option is the mean score of all 5 questions representing 0 with no impairment/limitation and 6 as total impairment/ limitation. Higher scores indicated more limitations and lower scores with better asthma control. Impact on asthma control in the subgroup of participants with an ACQ-5 score greater than 0.75 (indicating partially or not well-controlled) at baseline was assessed in a pre-specified pooled analysis across replicate studies 217095 (NCT05274750) and 218079 (NCT05281523). Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.

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 drug 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. The overall number of participants analyzed signifies participants evaluable for specified time points.

Posted

Least Squares Mean

Standard Error

Scores on scale

Baseline (Day 1) and at Week 52

ID	Title	Description
OG000	Pooled Depemokimab

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Depemokimab	Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	0	129	6	129	75	129
EG001	Placebo	Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.	0	128	10	128	78	128

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	27.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0011 events1 affected128 at risk
Atrial fibrillation	Cardiac disorders	27.1	Systematic Assessment	EG0001 events1 affected129 at risk EG0010 events0 affected128 at risk
Myocarditis	Cardiac disorders	27.1	Systematic Assessment	EG0001 events1 affected129 at risk EG0010 events0 affected128 at risk
Pancreatitis	Gastrointestinal disorders	27.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0011 events1 affected128 at risk
Biliary dilatation	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0011 events1 affected128 at risk
Cholecystitis acute	Hepatobiliary disorders	27.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0011 events1 affected128 at risk
COVID-19	Infections and infestations	27.1	Systematic Assessment	EG0001 events1 affected129 at risk EG0010 events0 affected128 at risk
Chronic sinusitis	Infections and infestations	27.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0011 events1 affected128 at risk
Peri-implantitis	Infections and infestations	27.1	Systematic Assessment	EG0002 events1 affected129 at risk EG0010 events0 affected128 at risk
Pneumonia	Infections and infestations	27.1	Systematic Assessment	EG0001 events1 affected129 at risk EG0011 events1 affected128 at risk
Procedural pain	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0001 events1 affected129 at risk EG0010 events0 affected128 at risk
Radius fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0011 events1 affected128 at risk
Rib fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0011 events1 affected128 at risk
Sternal fracture	Injury, poisoning and procedural complications	27.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0011 events1 affected128 at risk
Cerebrovascular insufficiency	Nervous system disorders	27.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0011 events1 affected128 at risk
Ischaemic stroke	Nervous system disorders	27.1	Systematic Assessment	EG0001 events1 affected129 at risk EG0010 events0 affected128 at risk
Ureterolithiasis	Renal and urinary disorders	27.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0011 events1 affected128 at risk
Heavy menstrual bleeding	Reproductive system and breast disorders	27.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0011 events1 affected128 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0012 events2 affected128 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0000 events0 affected129 at risk EG0011 events1 affected128 at risk
Hypertension	Vascular disorders	27.1	Systematic Assessment	EG0001 events1 affected129 at risk EG0010 events0 affected128 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	27.1	Systematic Assessment	EG0006 events6 affected129 at risk EG0012 events2 affected128 at risk
COVID-19	Infections and infestations	27.1	Systematic Assessment	EG0009 events9 affected129 at risk EG00111 events11 affected128 at risk
Influenza	Infections and infestations	27.1	Systematic Assessment	EG0003 events3 affected129 at risk EG0015 events5 affected128 at risk
Nasopharyngitis	Infections and infestations	27.1	Systematic Assessment	EG00039 events28 affected129 at risk EG00122 events15 affected128 at risk
Pharyngitis	Infections and infestations	27.1	Systematic Assessment	EG0004 events4 affected129 at risk EG0015 events5 affected128 at risk
Upper respiratory tract infection	Infections and infestations	27.1	Systematic Assessment	EG00020 events14 affected129 at risk EG00122 events15 affected128 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0004 events3 affected129 at risk EG00111 events6 affected128 at risk
Back pain	Musculoskeletal and connective tissue disorders	27.1	Systematic Assessment	EG0003 events3 affected129 at risk EG0019 events8 affected128 at risk
Headache	Nervous system disorders	27.1	Systematic Assessment	EG00015 events11 affected129 at risk EG00117 events13 affected128 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0003 events2 affected129 at risk EG0018 events6 affected128 at risk
Cough	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0006 events5 affected129 at risk EG00110 events8 affected128 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0006 events6 affected129 at risk EG0016 events4 affected128 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0008 events5 affected129 at risk EG00116 events14 affected128 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG00012 events7 affected129 at risk EG00115 events11 affected128 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	27.1	Systematic Assessment	EG0004 events4 affected129 at risk EG0017 events4 affected128 at risk
Hypertension	Vascular disorders	27.1	Systematic Assessment	EG0002 events2 affected129 at risk EG0016 events5 affected128 at risk

First MCP Posted Date

ID	Term
D009298	Nasal Polyps

Ancestor Terms

ID	Term
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases
D011127	Polyps
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Participants received placebo SC injection once every 26 weeks (week 0 and week 26) over a treatment period of 52-weeks. Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.

This reporting arm contains the pooled population of treated participants from the clinical trial groups "Depemokimab" study intervention from protocol 217095 and protocol 218079. Participants received a 100 mg dose of depemokimab SC injection once every 26 weeks (week 0 and week 26). Participants were to be maintained on their existing baseline maintenance CRSwNP SOC treatment throughout the study.