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New treatment option for Chronic Rhinosinusitis With Nasal Polyps
Official title Identifying Predictors Of Response To Mepolizumab In CRSwNP
ClinicalTrials.gov ID: NCT05902325
What this study is testing
What is Mepolizumab 100 MG Injection?
Mepolizumab 100 MG Injection is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for chronic rhinosinusitis with nasal polyps.
Also referred to as Nucala.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The investigators propose a real-world study to assess the mechanism of action of long-lasting response to mepolizumab in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) and identify clinically useful predictors of response. Mepolizumab is a monoclonal antibody targeting IL-5 and is approved for use in asthma and CRSwNP.
- Phase 4: studies an already-approved treatment
- Time commitment: about 48 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Bilateral NP, as diagnosed by endoscopy or historical CT scan
- At least one NP surgery\ within the last 10 years.
- Severe NP symptoms consistent with a need for surgery (obstruction VAS symptom score\>5, overall, VAS symptom score \>7, endoscopic bilateral NP...
- Ongoing treatment with INCS (via spray or intranasal liquid steroid wash/douching) for ≥4 weeks prior to screening
- ≥2 of the following CRS symptoms for at least 12 weeks:
You likely can't join if
- If as a result of a medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for...
- 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 tract infection (URTI) at screening or 2 weeks prior to screening
See the full eligibility criteria
- Bilateral NP, as diagnosed by endoscopy or historical CT scan
- At least one NP surgery\ within the last 10 years.
- Severe NP symptoms consistent with a need for surgery (obstruction VAS symptom score\>5, overall, VAS symptom score \>7, endoscopic bilateral NP score ≥4 [with a score ≥2 in each nasal cavity]).
- Ongoing treatment with INCS (via spray or intranasal liquid steroid wash/douching) for ≥4 weeks prior to screening
- ≥2 of the following CRS symptoms for at least 12 weeks:
- Nasal blockage/obstruction/congestion
- Nasal discharge (anterior/posterior nasal drip)
- Facial pain/pressure
- Reduction or loss of sense of smell
- If as a result of a 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 tract infection (URTI) at screening or 2 weeks prior to screening
- Ongoing rhinitis medicamentosa (rebound or chemical-induced rhinitis)
- Participants who have undergone any intranasal and/or sinus surgery (for example polypectomy, balloon dilatation or nasal stent insertion) within 6 months prior to V1
- Participants where NP surgery is contraindicated in the opinion of the Investigator
- Participants with a known medical history of 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 the screening visit, 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...
- Participants with a history of allergic reaction to anti-IL-5 or other monoclonal antibody therapy.
- Use of systemic corticosteroids (including oral corticosteroids) within 4 weeks prior to screening or planned use of such medications during the blinded period
- 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 allergen immunotherapy within the previous 3 months.
- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study. Contraceptive use will be required with a double barrier method or documented effective surgical sterilization.
- Immunocompromised people from disease or medication, other than oral corticosteroids.
- Women of childbearing potential (WOCBP) will be included with measures to prevent accidental exposure to IMP by using double barrier contraception and pregnancy test prior to injection.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 48 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.