Dupilumab for Severe Eosinophilic Chronic Sinusitis

Overseen By Thanh Q Tran, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of South Florida

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The investigators will investigate the efficacy of dupilumab in patients with severe eosinophilic CRSsNP who are resistant to the conventional treatment with intranasal corticosteroids and have significantly extensive disease involving more than 2 sinuses bilaterally in sinus CT scan and Lund-Mackay sinus (LMK) CT score \>=10 at baseline.

Research Team

Seong Cho, MD

Principal Investigator

University of South Florida

Eligibility Criteria

Adults with severe eosinophilic chronic sinusitis without nasal polyps, who haven't improved after at least 8 weeks of standard nasal corticosteroid treatment. Participants must have a high Lund-Mackay CT score (≥10), significant blood eosinophils (≥200), and experience symptoms like nasal blockage or loss of smell. Excluded are those with certain other conditions, recent infections requiring antibiotics, immunodeficiencies, cancer history within 5 years, drug abuse in the past year, pregnancy, breastfeeding or participation in another clinical trial.

Inclusion Criteria

LMK-CT score ≥ 10 (out of maximum of 24) at screening

Age 18 or older

The person has bilateral sinusitis, meaning that they have infection in both of their sinuses, and it has not been cured by using a corticosteroid treatment for at least 8 weeks.

Exclusion Criteria

Patients with conditions/concomitant diseases making them non-evaluable at screening or for the primary efficacy endpoint such as: Antrochoanal polyps, Nasal septal deviation that would occlude at least one nostril, Acute sinusitis, nasal infection or upper respiratory infection at screening, Ongoing rhinitis medicamentosa, Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome or other dyskinetic ciliary syndromes, concomitant cystic fibrosis, Radiologic suspicion, or confirmed invasive or expansive fungal rhinosinusitis, With co-morbid asthma are excluded if forced expiratory volume (FEV1) is 50% (of predicted normal) or less, With known active bacterial, viral, fungal, mycobacterial infection, or other infection or any major episode of infection that required hospitalization or treatment with IV antibiotics within 30 days of screening or during screening or oral antibiotics within 14 days prior to screening. Fungal infection of nail beds is allowed, Have human immunodeficiency virus/acquired immune deficiency syndrome, Have acute or chronic hepatitis B/hepatitis C infection, History of an opportunistic infection (eg, pneumocystis carinii, cryptococcal meningitis, progressive multifocal leukoencephalopathy) or serious bacterial, viral, or fungal infections (eg, disseminated herpes simplex, disseminated herpes zoster) and requiring IV medication(s) ≤ 3 weeks prior to randomization, History of or currently active primary or secondary immunodeficiency, History of cancer within the last 5 years, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved) or colonic mucosal dysplasia, History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder, or multiple myeloma, History of alcohol or drug abuse within 1 year prior to randomization, Receipt of live vaccine within 4 weeks prior to randomization, Pregnant or breastfeeding, Participation in another clinical study or treatment with an investigational drug or device, Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol

You have received an experimental monoclonal antibody within the past 6 months or within five times its half-life if its duration is unknown.

You have previously participated in a clinical trial for a medication called dupilumab.

Treatment Details

Interventions

• Dupilumab (Monoclonal Antibodies)

Trial Overview The study is testing Dupilumab's effectiveness for patients with severe eosinophilic chronic sinusitis who don't respond to usual treatments. It involves comparing Dupilumab injections against a placebo to see if it can reduce disease severity as shown by CT scans and symptom scores.

Participant Groups

Group I: Active drug Active Control 1 Intervention

Dupilumab 300 mg every other week for 24 weeks

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+