Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps

NCT05274750 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 2170952021-005037-16
• Study Type: interventional
• Target: 276
• Locations: 11 countries
• Sites: 105

Brief Summary

This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with Chronic rhinosinusitis with nasal polyps (CRSwNP).

Conditions

Nasal Polyps

Keywords

Depemokimab; GSK3511294; Chronic rhinosinusitis; Verbal response scale; Asthma Control Questionnaire; Lund Mackay computed tomography; Nasal polyps score; Nasal endoscopy

Outcome Measures

Primary Outcomes (2)

• 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 Week 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. The average of daily scores in 4-weekly intervals were calculated and data are presented for Weeks 49-52. Baseline was defined as the average score from 28 days of electronic diary (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 (10)

• 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

• Change From Baseline in Mean Symptom Score for Loss of Smell Using Verbal Response Scale From Week 49 Through to Week 52

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

• Change From Baseline in Lund Mackay Computerized Tomography (CT) Score at Week 52

  Baseline (Day 1) and at Week 52

• Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52

  Baseline (Day 1) and at Week 52

• Change From Baseline in Mean Nasal Obstruction Score (Verbal Response Scale) From Week 21 Through to Week 24

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

Study Arms (2)

Depemokimab

EXPERIMENTAL

Participants received a 100 milligram (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 for 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 for CRSwNP SOC treatment throughout the study.

Drug: Placebo

Interventions

Depemokimab (GSK3511294) BIOLOGICAL

Depemokimab (GSK3511294) was administered using a pre- filled syringe.

Depemokimab

Placebo DRUG

Placebo was administered as normal saline using a pre-filled syringe.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 the 8 weeks immediately 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.

You may not qualify if:

• 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 \[e.g.\], 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (105)

GSK Investigational Site

Tucson, Arizona, 85704, United States

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GSK Investigational Site

Buena Park, California, 90621, United States

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Los Angeles, California, 90006, United States

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San Diego, California, 91942, United States

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Stanford, California, 94304, United States

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Temecula, California, 92592, United States

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Aurora, Colorado, 80045, United States

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Gainesville, Florida, 32605, United States

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Tamarac, Florida, 33321, United States

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Tampa, Florida, 33613, United States

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Meridian, Idaho, 83642, United States

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Meridian, Idaho, 83706, United States

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Chicago, Illinois, 60612, United States

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Lexington, Kentucky, 40509, United States

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Louisville, Kentucky, 40205, United States

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Boston, Massachusetts, 02135, United States

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New Brunswick, New Jersey, 08901, United States

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Great Neck, New York, 11021, United States

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Rochester, New York, 14642, United States

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Chapel Hill, North Carolina, 27599, United States

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Cincinnati, Ohio, 45267, United States

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Tulsa, Oklahoma, 74137, United States

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Bethlehem, Pennsylvania, 18017, United States

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Providence, Rhode Island, 02914, United States

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Dallas, Texas, 75390-9035, United States

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Richmond, Virginia, 23235, United States

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Buenos Aires, 1023, Argentina

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Buenos Aires, C1425BEN, Argentina

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Buenos Aires, C1426ABP, Argentina

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Ciudad Autonoma de Bueno, C1121ABE, Argentina

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Florida, B1602DOH, Argentina

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La Plata, 1900, Argentina

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Mar del Plata, 7600, Argentina

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Mendoza, 5500, Argentina

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Mendoza, M5500CCG, Argentina

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Rosario, S2000DBS, Argentina

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Ghent, 9000, Belgium

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Hamilton, Ontario, L8L 2X2, Canada

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London, Ontario, N6A 4V2, Canada

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Ottawa, Ontario, K1H 1E4, Canada

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Montreal, Quebec, H2V 2K1, Canada

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Montreal, Quebec, H2X 3E4, Canada

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Québec, Quebec, G1S 4L8, Canada

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Québec, Quebec, G1V 4W2, Canada

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Beijing, 100191, China

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Beijing, 100730, China

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Dongguan, 523326, China

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Jingzhou, 434020, China

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Nanchang, 330006, China

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Qingdao, 266061, China

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Shanghai, 200065, China

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Taiyuan, 300201, China

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Wenzhou, 325000, China

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Wuhan, 430022, China

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Yantai, 264000, China

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Clermont-Ferrand, 63003, France

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Créteil, 94010, France

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Grenoble, 38043, France

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La Roche-sur-Yon, 85925, France

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La Rochelle, 17019, France

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Marseille, 13005, France

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Montpellier, 34295, France

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Nantes, 44093, France

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Pontoise, 95300, France

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Toulouse, 31059, France

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Valenciennes, 59322, France

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Bonn, 53127, Germany

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Dortmund, 44137, Germany

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Dresden, 01139, Germany

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Dresden, 01307, Germany

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Düsseldorf, 40225, Germany

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Düsseldorf, 40549, Germany

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Marburg, 35043, Germany

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München, 81377, Germany

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Münster, 48149, Germany

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Wiesbaden, 65183, Germany

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GSK Investigational Site

Ehime, 790-0024, Japan

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GSK Investigational Site

Ehime, 798-8510, Japan

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Fukui, 910-1193, Japan

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Fukuoka, 806-8501, Japan

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Ishikawa, 920-0293, Japan

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Kanagawa, 231-8682, Japan

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Kanagawa, 250-8558, Japan

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Kumamoto, 860-0814, Japan

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Kyoto, 600-8216, Japan

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GSK Investigational Site

Mie, 514-8507, Japan

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Nagano, 392-8510, Japan

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Osaka, 560-0082, Japan

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Osaka, 570-8507, Japan

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Tokyo, 160-0023, Japan

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Tokyo, 173-0026, Japan

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GSK Investigational Site

Amsterdam, 1105 AZ, Netherlands

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Leiden, 2353 GA, Netherlands

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Barcelona, 08022, Spain

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Barcelona, 08036, Spain

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GSK Investigational Site

Jerez de la Frontera, 11407, Spain

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Madrid, 28034, Spain

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Madrid, 28040, Spain

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Pamplona, 31008, Spain

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Seville, 41009, Spain

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Valladolid, 47005, Spain

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Zaragoza, 50009, Spain

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Great Yarmouth, NR31 6LA, United Kingdom

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Stevenage, SG1 4AB, United Kingdom

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Wigan, WN1 2NN, United Kingdom

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Related Publications (3)

• 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

  BACKGROUND

• 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.

  PMID: 41461999 DERIVED

• Gevaert P, Desrosiers M, Cornet M, Mullol J, De Corso E, Keles Turel N, Maspero J, Fujieda S, Zhang L, Sousa AR, Woods SJ, Davis AM, Schalkwijk S, Edwards D, Ranganathan P, Follows R, Marshall C, Han JK; ANCHOR-1 and ANCHOR-2 trial investigators. Efficacy and safety of twice per year depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1 and ANCHOR-2): phase 3, randomised, double-blind, parallel trials. Lancet. 2025 Mar 15;405(10482):911-926. doi: 10.1016/S0140-6736(25)00197-7. Epub 2025 Mar 1.

  PMID: 40037388 DERIVED

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This will be a double-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will receive either depemokimab (GSK3511294) or placebo during the study.

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 10, 2022
• Study Start: April 22, 2022
• Primary Completion: July 30, 2024
• Study Completion: August 27, 2024
• Last Updated: December 3, 2025
• Results First Posted: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

AR (10); JP (15); CN (11); ES (9); US (26); CA (7); BE (1); NL (2); GB (3); FR (11); DE (10)