Last updated: 12/03/2025 12:10:25
Efficacy and safety of depemokimab (GSK3511294) in participants with chronic rhinosinusitis with nasal polypsANCHOR-1
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomised, double-blind, parallel group Phase III study to assess the efficacy and safety of 100 mg SC depemokimab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) – ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis)
Trial description: This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with Chronic rhinosinusitis with nasal polyps (CRSwNP).
Primary purpose:
Treatment
Trial design:
Parallel
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 (Centrally Read)
Timeframe: 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
Timeframe: Baseline (Day 1) and from Week 49 to Week 52
Secondary outcomes:
Change from Baseline in Mean Symptom Score for Rhinorrhea (Runny Nose) Using Verbal Response Scale from Week 49 Through to Week 52
Timeframe: 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
Timeframe: Baseline (Day 1) and from Week 49 to Week 52
Change from Baseline in Lund Mackay Computerized Tomography (CT) Score at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Change from Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52
Timeframe: 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
Timeframe: Baseline (Day 1) and from Week 21 to Week 24
Change from Baseline in Total Endoscopic Nasal Polyps Score at Week 26
Timeframe: Baseline (Day 1) and at Week 26
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
Timeframe: Up to Week 52
Percentage of Participants Requiring First Nasal Surgery (Actual) or Disease-Modulating Medication for CRSwNP up to Week 52
Timeframe: Up to Week 52
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
Timeframe: Up to Week 52
Change from Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 52
Timeframe: Baseline (Day 1) and at Week 52
Interventions:
Enrollment:
276
Primary completion date:
2024-30-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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
Medical condition
Nasal Polyps
Product
Not applicable
Collaborators
Not applicable
Study date(s)
April 2022 to August 2024
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- Exclusion criteria:
- As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study.
Inclusion and exclusion 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 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.
Exclusion criteria:
- 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 [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.
- 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 of 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 ionizing 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.
Trial location(s)
Location
GSK Investigational Site
New Brunswick, NJ, United States, 08901
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Bueno, Argentina, C1121ABE
Status
Study Complete
Location
GSK Investigational Site
Great Yarmouth, United Kingdom, NR31 6LA
Status
Study Complete
Location
GSK Investigational Site
Darlington, United Kingdom, DL3 6HX
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lebanon, NH, United States, 03756
Status
Terminated/Withdrawn
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2024-30-07
Actual study completion date
2024-27-08
Plain language summaries
Summary of results in plain language
Available language(s): English, Dutch (Belgium), Dutch, French (Belgium), French (Canadian), French, German, Japanese, Chinese (Simplified), Spanish (Argentina), Spanish, Spanish (United States)
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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