Identifying Predictors Of Response To Mepolizumab In CRSwNP

Launched by CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL (CHUM) · Jun 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well a medication called mepolizumab works for patients with chronic rhinosinusitis with nasal polyps (CRSwNP), a condition that causes long-lasting nasal congestion and other symptoms due to swollen nasal passages. Researchers want to understand why some patients experience lasting improvements even after they stop taking the medication. Mepolizumab is already approved for treating asthma and CRSwNP, and it has shown promise in helping to reduce symptoms and the need for surgery.

To participate in the study, individuals must have a certain level of nasal polyps and have had surgery for them in the past ten years. They should also have been experiencing severe symptoms for at least 12 weeks. The trial is open to people aged between 65 and 74, and both men and women can join. Participants will receive the study medication and will be monitored to see how they respond. It's important to note that there are specific health conditions that might prevent someone from joining, so potential participants will need to discuss their medical history with the study team. Overall, this trial aims to find out more about the long-term benefits of mepolizumab and help identify which patients might benefit the most from this treatment.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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 their participation. Aspirin-sensitive participants are acceptable.
• • 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 double-blind 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 subjects 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.