Nasal PolypsPhase 3MERITNCT04607005

Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS)

A Phase 3 study testing Mepolizumab in people with Nasal Polyps, run by GlaxoSmithKline at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Nasal Polyps
What is being tested?: Mepolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 169 participants
Where: 1 siteJapan
Study dates: 8 Feb 2021to 4 Jul 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants of 18 years of age and older inclusive, at the time of signing the informed consent.
Body weight greater than or equal to 40 kilograms (kg).
Male or female participants (with appropriate contraceptive methods) to be eligible for entry into the study.
Female participant is eligible to participate if she is not pregnant or breastfeeding, one of the following conditions applies:
Is a woman of non- childbearing potential (WONCBP) : or
Is a woman of child bearing potential (WOCBP) and using a contraceptive method that is highly effective [with a failure rate of less than (<)1percent (%) per year], preferably with low user dependency, during the study intervention period and for at least 105 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (for example [e.g.] noncompliance, recently initiated) in relationship to the first dose of study intervention.

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A WOCBP must have a negative highly sensitive urine pregnancy test within 24 hours before the first dose of study intervention.
If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
A documented blood eosinophil count of over 2% in the 12 months prior to Visit 0 or through a blood sample taken between Visit 0 and Visit 1. All participants must meet blood eosinophil count of over 2% by Visit 1. Participants with peripheral blood eosinophil count over 2% to 5% must also have comorbid bronchial asthma, aspirin intolerance, or nonsteroidal anti-inflammatory drug intolerance at Visit 1 assessment in order to return for Visit 2.
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 with severe NP symptoms defined as a nasal obstruction VAS symptom score of greater than (>)5.
Presence of symptoms of CRS as described by at least two 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
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and study protocol.

Who cannot join

As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study. (e.g. symptomatic herpes zoster within 3 months prior to screening, evidence of tuberculosis [TB] active or latent).
Cystic fibrosis
Eosinophilic granulomatosis with polyangiitis (also known as Churg Strauss syndrome), Young's, Kartagener's or dyskinetic ciliary syndromes.
Antrochoanal polyps.
Severe nasal septal deviation preventing full assesment of nasal polyps in both nostrils.
Acute sinusitis or upper respiratory tract infection (URTI) at screening or in 2 weeks prior to screening.

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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.
Participants where NP surgery is contraindicated in the opinion of the Investigator.
Participants with a known medical history of Human Immunodeficiency Virus (HIV) infection.
Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1.
Participants who are currently receiving or have received within 3 months (or 5 half-lives - whatever is the longest) prior to first mepolizumab dose, chemotherapy, radiotherapy or investigational medications/therapies.
Participants with a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation. Aspirin sensitive participants are acceptable.
Participants with a history of allergic reaction to anti-IL-5 or other monoclonal antibody therapy.
Participants that have taken part in previous mepolizumab clinical studies.
Participants currently using intranasal corticosteroids (INCS) and inhaled corticosteroids exhalation through nose (ICS/ETN) for the management of their ECRS who are not willing to maintain using this method of administration throughout the study.
Use of systemic corticosteroids (including oral corticosteroids) or corticosteroid nasal solution (intranasal corticosteroid is excepted) within 4 weeks prior to screening or planned use of such medications during the double-blind period.
INCS and/or inhaled corticosteroids exhalation through nose (ICS/ETN) dose changes within 1 month prior to Visit 1 (if applicable).
Treatments with biological or immunosuppressive treatment (other than Xolair) treatment within 5 terminal phase half-lives of Visit 1.
Omalizumab (Xolair) treatment in the 130 days prior to Visit 1.
Commencement or change of dose of leukotriene antagonist treatment less than 30 days prior to Visit 1.
Commencement or change of dose of allergen immunotherapy within the previous 3 months.
Women who are pregnant or lactating or are planning on becoming pregnant during the study.
Any participant who is considered unlikely to survive the duration of the study period or has any rapidly progressing disease or immediate life-threatening illness (e.g. cancer). In addition, any participant who has any other condition (e.g. neurological condition) that is likely to affect respiratory function should not be included in the study.
Participants who have known, pre-existing, clinically significant endocrine, autoimmune, cardiovascular, metabolic, neurological, renal, gastrointestinal, hepatic, hematological or any other system abnormalities that are uncontrolled with standard treatment.
Participants with symptoms suggestive of active Coronavirus Disease-2019 (COVID-19) infection (that is fever, cough etc) are excluded.
Participants with known COVID-19 positive contacts within the past 14 days should be excluded for at least 14 days since the exposure and the participant remains symptom free.
A known immunodeficiency (e.g. HIV), other than that explained by the use of corticosteroids taken as therapy.
A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
Alanine aminotransferase (ALT) >2 times Upper limit of normal (ULN).
Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
Participants with a QT interval, from the electrocardiogram (ECG) conducted at Screening Visit 1, corrected with Fridericia's formula (QTcF) >450 milliseconds (msec) (or QTcF >480msec in participants with bundle branch block).
Known or suspected history of alcohol or drug abuse within 2 years prior to Screening (Visit 1) that in the opinion of the investigator would prevent the participant from completing the study procedures.
Is an investigator, sub-investigator, and study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study.
In the opinion of the investigator, any participant who is unable to read and/or would not be able to complete a questionnaire.

Trial locations and contacts

1 site in 1 country.

Japan1 site

GSK Investigational Site
Chiba, 262-0015

Other trials in Japan

About this study

Official title: A Randomised, Double-blind, Placebo Controlled, Parallel Group Phase III Study to Assess the Clinical Efficacy and Safety of 100 mg SC Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) / Eosinophilic Chronic Rhinosinusitis (ECRS) MERIT: Mepolizumab in Eosinophilic Chronic RhinosinusITis Study

This is a randomized, double blind, placebo controlled, parallel group phase III study designed to assess the clinical efficacy and safety of 100 milligrams (mg) subcutaneous (SC) mepolizumab treatment in adults with CRSwNP/ECRS for the purpose of registration in Japan and China. Approximately 160 participants will be randomized in a 1:1 ratio to receive either 100 mg SC mepolizumab or placebo SC. The study will include a 4-week run-in period followed by randomization to a 52-week treatment period, where participants will be administered 4-weekly doses of mepolizumab or placebo via a pre-filled safety syringe device (SSD) injection.

Conditions: Nasal Polyps
Being tested: Mepolizumab, Placebo, Standard of care
Keywords: Chronic rhinosinusitis, Eosinophilic chronic rhinosinusitis, Mepolizumab
Medical subject headings: Nasal Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MepolizumabDrug
Mepolizumab will be available as a clear to opalescent, colorless solution for SC injection in a single-use, safety syringe at a unit dose strength of 100 mg/milliliters (mL).
PlaceboDrug
Placebo will be available as a clear to opalescent, colorless sterile solution for SC injection in a single-use, safety syringe
Standard of careDrug
Participants will continue to receive Standard of care as they are used to before entry in the study.

Study groups in NCT04607005
Study group	Role	What they receive
Participants receiving mepolizumab + Standard of care (SoC)	Experimental	Participants will receive one dose of 100 mg mepolizumab SC on top of SoC every 4 weeks during the 52-week treatment period. Receives: Drug: Mepolizumab; Drug: Standard of care
Participants receiving placebo + SoC	Placebo comparator	Participants will receive one dose of placebo via SC route on top of SoC, every 4 weeks during the 52-week treatment period. Receives: Drug: Placebo; Drug: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 - ITT Population Excluding Medipharma Managed Sites
Total endoscopic nasal polyp score is collected at clinical visits. Independent reviewers, blinded to treatment, reviewed image recordings of nasal endoscopies to determine total endoscopic NP score based on NP size. 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/congestion of the inferior meatus). The total score is the sum of the right and left nostril scores and ranges from 0 to 8 (calculated by summing the scores [0 to 4] in each nostril), higher scores indicate worse status. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.
Measured: Baseline (Day 1) up to week 52
Mean Change From Baseline in Total Endoscopic NP Score at Week 52 - Intent-to-Treat (ITT) Population
Total endoscopic nasal polyp score is collected at clinical visits. The assessments were performed by central video image recordings of nasal endoscopy (NE). 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/congestion of the inferior meatus). The total score is the sum of the right and left nostril scores and ranges from 0 to 8 (calculated by summing the scores [0 to 4] in each nostril), "0" score represents better status while "8" represents worse status. Baseline was defined as last value prior to first dose (Day 1). Change from Baseline = Post-baseline value minus Baseline value.
Measured: Baseline (Day 1) up to Week 52
Mean Change From Baseline in Mean Nasal Obstruction Visual Analogue Scale (VAS) Score During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites
Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale (VAS) using an electronic diary (eDiary). Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final nasal obstruction VAS score ranged between 0 (none) and 10 (worst), with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
Measured: Baseline (Day 1) up to 4 weeks prior to week 52
Mean Change From Baseline in Mean Nasal Obstruction VAS Score During the 4 Weeks Prior to Week 52 - ITT Population
Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale (VAS) using an electronic diary (eDiary). Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores dividing by 10. The final nasal obstruction VAS score ranged between 0 and 10, with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
Measured: Baseline (Day 1) up to 4 weeks prior to week 52

Secondary outcomes (12)

Mean Change From Baseline in Mean Overall VAS Symptom Score During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites
Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final overall VAS score ranged between 0 (none) and 10 (worst), with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
Measured: Baseline (Day 1) up to 4 weeks prior to week 52
Mean Change From Baseline in Mean Overall VAS Symptom Score During the 4 Weeks Prior to Week 52 - ITT Population
Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final overall VAS score ranged between 0 (none) and 10 (worst), with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
Measured: Baseline (Day 1) up to 4 weeks prior to week 52
Mean Change From Baseline in Lund Mackay (LMK) Computed Tomography (CT) Score at Week 52 - ITT Population Excluding Medipharma Managed Sites
The LMK CT scoring system is based on localization with points given for degree of opacification: 0 =normal, 1 = partial opacification, 2 = total opacification. These points are then applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side. The osteomeatal complex (OC) was graded as 0 = not occluded, or 2 = occluded deriving a maximum score of 12 per side. The range for the LMK CT score is therefore 0-24 (higher scores indicating more opacification) when summed across both sides. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.
Measured: Baseline (Day 1) and Week 52
Mean Change From Baseline in LMK CT Score at Week 52 - ITT Population
The LMK CT scoring system is based on localization with points given for degree of opacification: 0 =normal, 1 = partial opacification, 2 = total opacification. These points are then applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side of the nostril. The osteomeatal complex (OC) was graded as 0 = not occluded, or 2 = occluded deriving a maximum score of 12 per side. The range for the LMK CT score is therefore 0-24 (higher scores indicating more opacification) when summed across both sides. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.
Measured: Baseline (Day 1) and Week 52
Mean Change From Baseline in the Mean Composite VAS Score [Combining VAS Scores for Nasal Obstruction, Nasal Discharge, Mucus in the Throat and Loss of Smell] During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites
Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from electronically captured scores by dividing by 10. The composite VAS score was calculated as average of individual scores of nasal obstruction, nasal discharge, mucus in the throat and loss of smell and ranged between 0 (none) and 10 (worst), with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
Measured: Baseline (Day 1) up to 4 weeks prior to week 52
Mean Change From Baseline in the Mean Composite VAS Score [Combining VAS Scores for Nasal Obstruction, Nasal Discharge, Mucus in the Throat and Loss of Smell] During the 4 Weeks Prior to Week 52 - ITT Population
Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from electronically captured scores by dividing by 10. The composite VAS score was calculated as average of individual scores of nasal obstruction, nasal discharge, mucus in the throat and loss of smell and ranged between 0 (none) and 10 (worst), with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
Measured: Baseline (Day 1) up to 4 weeks prior to week 52
Mean Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52 - ITT Population Excluding Medipharma Managed Sites
SNOT-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 representing worse quality of life. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.
Measured: Baseline (Day 1) up to Week 52
Mean Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52 - ITT Population
SNOT-22 is a 22-questions 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 all SNOT-22 items ranging from 0 (high quality of life) to 110 (worst quality of life). Lower score indicating better HRQoL. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.
Measured: Baseline (Day 1) up to Week 52
Mean Change From Baseline in Mean Individual VAS Symptom Score for Loss of Smell During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites
Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final loss of smell VAS score ranged between 0 (none) and 10 (worst), with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
Measured: Baseline (Day 1) up to 4 weeks prior to week 52
Change From Baseline in Mean Individual VAS Symptom Score for Loss of Smell During the 4 Weeks Prior to Week 52 - ITT Population
Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final loss of smell VAS score ranged between 0 (none) and 10 (worst), with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
Measured: Baseline (Day 1) up to 4 weeks prior to week 52
Percentage of Participants With Nasal Surgery or Systemic Corticosteroids (CS) for Chronic Rhinosinusitis With Nasal Polyposis/Eosinophilic Chronic Rhinosinusitis (CRSwNP/ECRS) Over Time- ITT Population Excluding Medipharma Managed Sites
NP surgery is defined as any procedure involving instruments resulting in incision and removal of tissue from the nasal cavity (for example polypectomy). Additionally, the number of courses of systemic steroids and reason for treatment will be recorded throughout the study. Percentage of participants with nasal surgery or course of systemic CS for CRSwNP/ECRS and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method.
Measured: At Week 8, 16, 24, 32, 40, 48 and Week 52
Percentage of Participants With Nasal Surgery or Course of Systemic CS for CRSwNP/ECRS up to Week 52 - ITT Population
NP surgery is defined as any procedure involving instruments resulting in incision and removal of tissue from the nasal cavity (for example polypectomy). Additionally, the number of courses of systemic steroids and reason for treatment will be recorded throughout the study. Percentage of participants with nasal surgery or course of systemic CS for CRSwNP/ECRS and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method.
Measured: At Week 8, 16, 24, 32, 40, 48 and Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 20214 Jul 2023

First posted28 Oct 2020
Study start8 Feb 2021
Primary completion12 Apr 2023
Study completion4 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Nasal PolypsStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomized in a ratio of 1:1 to receive a single SC dose of 100 mg mepolizumab or placebo every 4 weeks during 52-week treatment period.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 169 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04607005
Sponsor's protocol ID: 209692
Acronym: MERIT
Status last verified: Jul 2026
First submitted: 23 Oct 2020
Last updated: 22 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf

Publications

Fujieda S, Wang C, Yoshikawa M, Asako M, Suzaki I, Bachert C, Han JK, Fuller A, Baylis L, Su L, Sasaki E, Sousa AR, Chan R, Zhang L. Mepolizumab in CRSwNP/ECRS and NP: the phase III randomised MERIT trial in Japan, China, and Russia. Rhinology. 2024 Oct 1;62(5):576-589. doi: 10.4193/Rhin24.156.
PubMed 39058315

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
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RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
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Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
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Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
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All Nasal Polyps trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo Controlled, Parallel Group Phase III Study to Assess the Clinical Efficacy and Safety of 100 mg SC Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) / Eosinophilic Chronic Rhinosinusitis (ECRS) MERIT: Mepolizumab in Eosinophilic Chronic RhinosinusITis Study
ClinicalTrials.gov ID: NCT04607005
Acronym / sponsor ID: MERIT / 209692
Conditions: Nasal Polyps
Keywords: Chronic rhinosinusitis, Eosinophilic chronic rhinosinusitis, Mepolizumab
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 169 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: BioClinica, Inc., Signant Health
Study start: 8 Feb 2021 (actual)
Primary completion: 12 Apr 2023 (actual)
Study completion: 4 Jul 2023 (actual)
First posted: 28 Oct 2020 (actual)
Results: Posted 25 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: Participants will be randomized in a ratio of 1:1 to receive a single SC dose of 100 mg mepolizumab or placebo every 4 weeks during 52-week treatment period.

Arm	Type	Receives
Participants receiving mepolizumab + Standard of care (SoC)	Experimental	Drug: Mepolizumab, Drug: Standard of careParticipants will receive one dose of 100 mg mepolizumab SC on top of SoC every 4 weeks during the 52-week treatment period.
Participants receiving placebo + SoC	Placebo comparator	Drug: Placebo, Drug: Standard of careParticipants will receive one dose of placebo via SC route on top of SoC, every 4 weeks during the 52-week treatment period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Participants of 18 years of age and older inclusive, at the time of signing the informed consent.
Body weight greater than or equal to 40 kilograms (kg).
Male or female participants (with appropriate contraceptive methods) to be eligible for entry into the study.
Female participant is eligible to participate if she is not pregnant or breastfeeding, one of the following conditions applies:
Is a woman of non- childbearing potential (WONCBP) : or

Key exclusion criteria (38 listed)

As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study. (e.g. symptomatic herpes zoster within 3 months prior to screening, evidence of tuberculosis [TB] active or latent).
Cystic fibrosis
Eosinophilic granulomatosis with polyangiitis (also known as Churg Strauss syndrome), Young's, Kartagener's or dyskinetic ciliary syndromes.
Antrochoanal polyps.
Severe nasal septal deviation preventing full assesment of nasal polyps in both nostrils.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MepolizumabMepolizumab will be available as a clear to opalescent, colorless solution for SC injection in a single-use, safety syringe at a unit dose strength of 100 mg/milliliters (mL).	Drug	Participants receiving mepolizumab + Standard of care (SoC)
PlaceboPlacebo will be available as a clear to opalescent, colorless sterile solution for SC injection in a single-use, safety syringe	Drug	Participants receiving placebo + SoC
Standard of careParticipants will continue to receive Standard of care as they are used to before entry in the study.	Drug	Participants receiving mepolizumab + Standard of care (SoC), Participants receiving placebo + SoC

Primary outcome

Mean Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 - ITT Population Excluding Medipharma Managed Sites
Time frame: Baseline (Day 1) up to week 52
Total endoscopic nasal polyp score is collected at clinical visits. Independent reviewers, blinded to treatment, reviewed image recordings of nasal endoscopies to determine total endoscopic NP score based on NP size. 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/congestion of the inferior meatus). The total score is the sum of the right and left nostril scores and ranges from 0 to 8 (calculated by summing the scores [0 to 4] in each nostril), higher scores indicate worse status. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value.
Mean Change From Baseline in Total Endoscopic NP Score at Week 52 - Intent-to-Treat (ITT) Population
Time frame: Baseline (Day 1) up to Week 52
Total endoscopic nasal polyp score is collected at clinical visits. The assessments were performed by central video image recordings of nasal endoscopy (NE). 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/congestion of the inferior meatus). The total score is the sum of the right and left nostril scores and ranges from 0 to 8 (calculated by summing the scores [0 to 4] in each nostril), "0" score represents better status while "8" represents worse status. Baseline was defined as last value prior to first dose (Day 1). Change from Baseline = Post-baseline value minus Baseline value.
Mean Change From Baseline in Mean Nasal Obstruction Visual Analogue Scale (VAS) Score During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites
Time frame: Baseline (Day 1) up to 4 weeks prior to week 52
Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale (VAS) using an electronic diary (eDiary). Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final nasal obstruction VAS score ranged between 0 (none) and 10 (worst), with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.
Mean Change From Baseline in Mean Nasal Obstruction VAS Score During the 4 Weeks Prior to Week 52 - ITT Population
Time frame: Baseline (Day 1) up to 4 weeks prior to week 52
Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale (VAS) using an electronic diary (eDiary). Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores dividing by 10. The final nasal obstruction VAS score ranged between 0 and 10, with higher scores indicating greater disease severity. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value.

12 secondary outcomes

Mean Change From Baseline in Mean Overall VAS Symptom Score During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites
Time frame: Baseline (Day 1) up to 4 weeks prior to week 52
Mean Change From Baseline in Mean Overall VAS Symptom Score During the 4 Weeks Prior to Week 52 - ITT Population
Time frame: Baseline (Day 1) up to 4 weeks prior to week 52
Mean Change From Baseline in Lund Mackay (LMK) Computed Tomography (CT) Score at Week 52 - ITT Population Excluding Medipharma Managed Sites
Time frame: Baseline (Day 1) and Week 52
Mean Change From Baseline in LMK CT Score at Week 52 - ITT Population
Time frame: Baseline (Day 1) and Week 52
Mean Change From Baseline in the Mean Composite VAS Score [Combining VAS Scores for Nasal Obstruction, Nasal Discharge, Mucus in the Throat and Loss of Smell] During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites
Time frame: Baseline (Day 1) up to 4 weeks prior to week 52
Mean Change From Baseline in the Mean Composite VAS Score [Combining VAS Scores for Nasal Obstruction, Nasal Discharge, Mucus in the Throat and Loss of Smell] During the 4 Weeks Prior to Week 52 - ITT Population
Time frame: Baseline (Day 1) up to 4 weeks prior to week 52
Mean Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52 - ITT Population Excluding Medipharma Managed Sites
Time frame: Baseline (Day 1) up to Week 52
Mean Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52 - ITT Population
Time frame: Baseline (Day 1) up to Week 52
Mean Change From Baseline in Mean Individual VAS Symptom Score for Loss of Smell During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites
Time frame: Baseline (Day 1) up to 4 weeks prior to week 52
Change From Baseline in Mean Individual VAS Symptom Score for Loss of Smell During the 4 Weeks Prior to Week 52 - ITT Population
Time frame: Baseline (Day 1) up to 4 weeks prior to week 52
Percentage of Participants With Nasal Surgery or Systemic Corticosteroids (CS) for Chronic Rhinosinusitis With Nasal Polyposis/Eosinophilic Chronic Rhinosinusitis (CRSwNP/ECRS) Over Time- ITT Population Excluding Medipharma Managed Sites
Time frame: At Week 8, 16, 24, 32, 40, 48 and Week 52
Percentage of Participants With Nasal Surgery or Course of Systemic CS for CRSwNP/ECRS up to Week 52 - ITT Population
Time frame: At Week 8, 16, 24, 32, 40, 48 and Week 52

Results and safety

Results posted to the registry on 25 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mepolizumab	84	78
Placebo	85	69

Primary outcome: Mean Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 - ITT Population Excluding Medipharma Managed Sites

Time frame: Baseline (Day 1) up to week 52. Least squares mean (Standard Error). Unit: Scores on a Scale

Measure	Mepolizumab n = 80	Placebo n = 83
Value	-0.62 (0.164)	-0.19 (0.164)

Mepolizumab vs Placebo: Mean Difference (Final Values): -0.43 (95% CI -0.89 to 0.03), p = 0.067, Mixed Models Analysis

Population analysed: The analysis was performed on the ITT Set (randomized participants who received at least 1 dose of study treatment) excluding participants from Medipharma managed sites. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using missing at random (MAR) assumption to handle missing data.

Primary outcome: Mean Change From Baseline in Total Endoscopic NP Score at Week 52 - Intent-to-Treat (ITT) Population

Time frame: Baseline (Day 1) up to Week 52. Least squares mean (Standard Error). Unit: Scores on a Scale

Measure	Mepolizumab n = 84	Placebo n = 85
Value	-0.65 (0.160)	-0.19 (0.162)

Mepolizumab vs Placebo: Mean Difference (Final Values): -0.47 (95% CI -0.92 to -0.02), p = 0.043, Mixed Models Analysis

Population analysed: The analysis was performed on the Intent to Treat (ITT) Set that included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using missing at random (MAR) assumption to handle missing data.

Primary outcome: Mean Change From Baseline in Mean Nasal Obstruction Visual Analogue Scale (VAS) Score During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites

Time frame: Baseline (Day 1) up to 4 weeks prior to week 52. Least squares mean (Standard Error). Unit: Scores on a Scale

Measure	Mepolizumab n = 80	Placebo n = 83
Value	-3.23 (0.336)	-1.80 (0.333)

Mepolizumab vs Placebo: Mean Difference (Final Values): -1.43 (95% CI -2.37 to -0.50), p = 0.003, Mixed Models Analysis

Primary outcome: Mean Change From Baseline in Mean Nasal Obstruction VAS Score During the 4 Weeks Prior to Week 52 - ITT Population

Time frame: Baseline (Day 1) up to 4 weeks prior to week 52. Least squares mean (Standard Error). Unit: Scores on a Scale

Measure	Mepolizumab n = 84	Placebo n = 85
Value	-3.20 (0.328)	-1.77 (0.331)

Mepolizumab vs Placebo: Mean Difference (Final Values): -1.43 (95% CI -2.35 to -0.51), p = 0.002, Mixed Models Analysis

Population analysed: The analysis was performed on the ITT Set that included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using MAR assumption to handle missing data.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 (first dose) to Week 52. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mepolizumab	0 of 84 (0%)	47 of 84 (56%)	0 of 84
Placebo	3 of 85 (3.5%)	52 of 85 (61.2%)	0 of 85

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 39058315Fujieda S, Wang C, Yoshikawa M, Asako M, Suzaki I, Bachert C, Han JK, Fuller A, Baylis L, Su L, Sasaki E, Sousa AR, Chan R, Zhang L. Mepolizumab in CRSwNP/ECRS and NP: the phase III randomised MERIT trial in Japan, China, and Russia. Rhinology. 2024 Oct 1;62(5):576-589. doi: 10.4193/Rhin24.156.
Individual participant dataSharing planned: Yes. GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mepolizumab in people with Nasal Polyps, run by GlaxoSmithKline at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 - ITT Population Excluding Medipharma Managed Sites (time frame: Baseline (Day 1) up to week 52). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04607005, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.