Chronic rhinosinusitis with nasal polyps (CRSwNP) who are inadequately controlled with standard trea
Conditions
Interventions
The study will include an approximate 4-week run-in period followed by 52-week treatment period.
Throughout the entire study, participants will be on the SoC for CRSwNP.
Since this study's objective i
Sponsors
Okamasa Arisa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 previous nasal surgery for the removal of nasal polyps, have used at least three consecutive days of systemic corticosteroids in the previous 2 years for the treatment of nasal polyps, or are medically unsuitable or intolerant to systemic corticosteroid - Participants presenting with severe nasal polyp symptoms defined as symptoms of nasal congestion/blockade/obstruction with moderate or severe severity and loss of smell or rhinorrhoea (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), or 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 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.NOTE: Participants that had localised carcinoma of the skin which was resected for cure will not be excluded - 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 enrolment - Participants with allergy/intolerance to the excipients of depemokimab, a monoclonal antibody, or biologic - 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 - Participants using INCS (including intranasal liquid steroid wash/douching) for at least 8 weeks immediately prior to screening - Participants on inhaled corticosteroids exhalation through nose (Inhaled corticosteroids exhalation through nose [ICS/ETN]) method of administration for their asthma and NP for at least the 8 weeks immediately prior to screening - Participants who have received depemokimab (Exdensur), mepolizumab (Nucala), reslizumab (Cinqair/Cinqaero), or benralizumab (Fasenra) within 12 months prior to Visit 1 or experienced treatment failure with monoclonal antibodies targeting IL-5/5R - Participants who have received omalizumab (Xolair), dupilumab (Dupixent) or Tezpelumab (Tezpire) within 130 days prior to Visit 1 - Previously participated in any study with depemokimab, mepolizumab, reslizumab, or benraliz
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Achieving a one point or greater decrease from baseline in total endoscopic NP Score at Week 52 (centrally read) without first having nasal surgery (actual) or disease-modulating medication for CRSwNP | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change from baseline in total endoscopic NP score at Week 52 (centrally read) - Change from baseline in mean nasal obstruction score (VRS) from Week 49 through to Week 52 - Change from baseline in mean symptom score for rhinorrhoea (runny nose) (VRS) from Week 49 through to Week 52 - Change from baseline in mean symptom score for loss of smell (VRS) from Week 49 through to Week 52 - Change from baseline in Lund Mackay CT score at Week 52 (centrally read) - Change from baseline in SNOT-22 total score at Week 52 | — |
Contacts
Public ContactArisa Okamasa
GlaxoSmithKline K.K.
Outcome results
None listed