Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID05902325

Identifying Predictors Of Long-Lasting Response To Mepolizumab In CRSwNP: Is The Disease-Modifying Role Secondary To Restored Anti-Viral Activity Or Enhanced Epithelial Regeneration?

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-02-14

36

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the long-lasting effects of mepolizumab in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP), a condition characterized by nasal polyps and severe symptoms. This study aims to understand how mepolizumab, a monoclonal antibody targeting IL-5, modifies the disease beyond eosinophil activity and to identify markers that predict which patients will have prolonged benefits after stopping treatment. The research also explores the potential role of viruses and epigenetic changes in the disease and response to therapy. Participants will receive 12 months of mepolizumab treatment given as 100 mg subcutaneous injections every 4 weeks for a total of twelve injections. The study is open-label and nonrandomized. Alongside mepolizumab, patients will continue using mometasone furoate nasal spray daily. Researchers will assess the effects before treatment, 6 months after starting treatment, and through a 12-month follow-up, using advanced molecular techniques, tissue analysis, and clinical evaluations to explore mechanisms of response and disease modification. Participants will undergo regular clinical assessments including nasal endoscopy and symptom scoring. Biological samples from nasal polyps will be collected for detailed molecular and epigenetic analysis. Researchers will monitor for persistent clinical response up to 18 months after stopping mepolizumab. Safety monitoring includes observation after injections for allergic reactions. The study will last about 18 months per participant, including treatment and follow-up periods, to evaluate long-term outcomes and identify predictors of lasting benefit.

CONDITIONS

Brief Title

Identifying Predictors Of Response To Mepolizumab In CRSwNP

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Bilateral nasal polyps diagnosed by endoscopy or historical CT scan
  • At least one nasal polyp surgery within the last 10 years
  • Severe nasal polyp symptoms indicating need for surgery (specific symptom scores required)
  • Ongoing treatment with intranasal corticosteroids for at least 4 weeks before screening
  • Presence of at least two chronic rhinosinusitis symptoms for at least 12 weeks, including nasal blockage, nasal discharge, facial pain or pressure, or loss of smell
Not Eligible

You will not qualify if you...

  • Considered unfit for the study by the responsible physician
  • Diagnosis of cystic fibrosis
  • Presence of eosinophilic granulomatosis with polyangiitis, Young's syndrome, Kartagener's syndrome, or dyskinetic ciliary syndromes
  • Antrochoanal polyps
  • Nasal septal deviation blocking one nostril
  • Acute sinusitis or upper respiratory tract infection at screening or within 2 weeks prior
  • Ongoing rebound or chemical-induced rhinitis
  • Nasal or sinus surgery within 6 months prior to first visit
  • Contraindication to nasal polyp surgery
  • Known HIV infection
  • Known parasitic infestation within 6 months prior to first visit
  • Recent radiotherapy or investigational treatments within 3 months prior to screening
  • Allergy or sensitivity to study medications or components (except aspirin-sensitive participants)
  • History of allergic reaction to anti-IL-5 or other monoclonal antibody therapy
  • Use of systemic corticosteroids within 4 weeks prior to screening or planned use during study
  • Recent biological or immunosuppressive treatments (except Xolair) within 5 half-lives prior to screening
  • Omalizumab (Xolair) treatment within 130 days prior to first visit
  • Recent start or dose change of allergen immunotherapy within 3 months
  • Pregnancy, lactation, or planning pregnancy during study without effective contraception
  • Immunocompromised status not due to oral corticosteroids
  • Women of childbearing potential must use double barrier contraception and have a negative pregnancy test prior to injections

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Treatment

Duration - 48 weeks

Participants receive Mepolizumab 100mg by subcutaneous injection once every 4 weeks for 48 weeks (twelve injections) at the hospital, along with daily intranasal corticosteroids. They will be monitored at the study site for at least 30 minutes after each injection for signs of hypersensitivity reaction.

12 monthly visits for injections and monitoring

Follow-up

Duration - Up to 6 months after treatment ends

Participants are followed for clinical assessments to evaluate the persistent response to treatment after completing the Mepolizumab injections.

Periodic clinical assessments as scheduled by the study team

Trial Site Locations

Total: 1 location

1

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada, H2X 3E4

Actively Recruiting

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Research Team

M

Martin Yvon Desrosiers, MD

L

Leandra Mfuna Endam, Msc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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