Can an asthma drug shrink nasal polyps? a major trial seeks answers

NCT ID NCT03085797

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether mepolizumab, an injectable antibody that calms a type of immune cell, can reduce nasal polyp size and improve breathing when added to standard nasal spray therapy. About 400 adults with severe bilateral nasal polyps will receive either mepolizumab or a placebo every four weeks for a year, alongside daily mometasone furoate nasal spray. The study measures changes in polyp size and nasal blockage scores to see if the drug offers meaningful relief.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mepolizumab, a monoclonal antibody that blocks interleukin-5, given as a subcutaneous injection every 4 weeks
What this could lead to
If it works, this could offer a new add-on treatment option for people with severe nasal polyps who still have symptoms despite standard therapy.
What could go wrong
This is a phase 3 trial, so earlier results were promising but not definitive. The drug may not improve symptoms enough to justify its use, and side effects from blocking part of the immune system are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

414 people

The number who actually took part.

Started

May 2017

Finished

Dec 2019

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * 18 years of age and older inclusive, at the time of signing the informed consent. * Body weight greater or equal to 40 kilogram (kg). * Male or female participants (with appropriate contraceptive methods) to be eligible for entry into the study. To be eligible for entry into the study, woman of childbearing potential (WOCBP) must commit to consistent and correct use of an acceptable method of birth control from the time of consent, for the duration of the trial, and for 105 days after last study drug administration. * Participants who have had at least one previous surgery in the previous 10 years for the removal of NP. NP Surgery is defined as any procedure involving instruments with resulting incision (cutting open) and removal of polyp tissue from the nasal cavity (polypectomy). For the purpose of inclusion into this study, any procedure involving instrumentation in the nasal cavity resulting in dilatation of the nasal passage such as balloon sinuplasty, insertion of coated stents or direct injection of steroids or other medication without any removal of NP tissue is not accepted. * Participants with bilateral NP as diagnosed by endoscopy or computed tomography (CT) scan. * Presence of at least two of the following symptoms one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip) and either nasal discharge (anterior/posterior nasal drip); facial pain/pressure; reduction or loss of smell for at least 12 weeks prior to screening. * Participants with severe NP symptoms defined as an obstruction VAS symptom score of \>5. * Severity consistent with a need for surgery as described by: 1. Participants with an overall VAS symptom score \>7, 2. Participants with an 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). * Treatment with intranasal corticosteroids (INCS) for at least 8 weeks prior to screening. * Capable of giving signed informed consent 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 * Eosinophilic granulomatosis with polyangiitis (also known as churg strauss syndrome), young's, kartagener's or dyskinetic ciliary syndromes. * Antrochoanal polyps * Nasal septal deviation occluding one nostril * Acute sinusitis or upper respiratory track 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 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 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 on a waiting list for NP surgery while at screening * Participants that have taken part in previous mepolizumab, reslizumab, dupilumab or benralizumab studies. * Use of systemic corticosteroids (including oral corticosteroids) or corticosteroid nasal solution (intranasal corticosteroid is accepted) within 4 weeks prior to Screening or planned use of such medications during the double-blind period. * INCS dose changes within 1 month prior to screening. * Treatments with biological or immunosuppressive treatment (other than omalizumab) treatment within 5 terminal phase half lives of Visit 1. * Omalizumab treatment in the 130 days prior to Visit 1. * Commencement of leukotriene antagonist treatment less than 30 days prior to Visit 1. * Allergen immunotherapy within the previous 3 months. * Women who are pregnant or lactating or are planning on becoming pregnant during the study. * Participants who currently smoke or have smoked in the last 6 months. * 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. * Immunocompromized, 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. Participants with successfully treated basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ, with no evidence of recurrence may participate in the study. * 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). * Corrected QT interval (QTc) \>450 milliseconds (msec) or QTc \>480 msec in participants with bundle branch block at visit 1. * A 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. * An investigator, sub-investigator, 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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