Add-on Dupilumab for AFRS as Postoperative Therapy (ADAPT)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Allergic Fungal Rhinosinusitis

In brief

The purpose of this study is to find a more effective treatment for allergic fungal rhinosinusitis (AFRS). Most people suffering from nasal polyps have elevated levels of white blood cells called eosinophils that are involved in inflammation of the air passages. Despite appropriate treatment with oral/topical corticosteroids, saline irrigations, and surgery, nasal polyps return frequently within months of surgery. Participants will be administered a placebo or dupilumab every two weeks for 52 weeks.

Key facts

Study ID

NCT05545072

Run by

Emory University

People needed

5

Starts

2023-10-26

Expected to finish

2024-07-10

Last updated by the study team

2025-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Capable of giving signed informed consent
• Patients aged >18 years at the time of signing the informed consent form (ICF)
• Patients with nasal polyps in the setting of suspected AFRS and electing to undergo comprehensive sinus surgery per established criteria
• Diagnosis of nasal polyps by consensus criteria
• Failure of appropriate medical therapy, including topical intranasal corticosteroid (spray or irrigation) > 8 weeks duration, systemic corticosteroid trial of 1-3 weeks duration, and nasal saline irrigation of > 4 weeks duration
• A minimum SNOT-22 score of 20 at the time of enrollment
• A minimum CT Lund-MacKay score of > 1 at the time of enrollment
• Suspected AFRS based on Bent and Kuhn criteria
• Patients meet 3/5 criteria at the time of enrollment and 5/5 criteria at time of randomization: environmental atopy by skin or serum testing, nasal polyposis, characteristic CT findings, eosinophilic mucous, fungal identification on histopathology

You may not qualify if…

• Patients who have undergone nasal or sinus surgery within 3 months prior to enrollment
• Patients with conditions or comorbid disease findings that exclude nasal endoscopy for evaluation of primary outcomes, such as current rhinitis medicamentosa, nasal cavity tumors, occlusive septal deviation following surgery
• Clinically important comorbidities that may confound the interpretation of clinical efficacy, including aspirin-exacerbated respiratory disease, cystic fibrosis, primary ciliary dyskinesia, Hereditary Hemorrhagic Telangiectasia, antrochoanal polyposis, non-asthma eosinophilic disease (such as bronchopulmonary aspergillosis, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome), granulomatosis with polyangiitis, any corticosteroid-dependent condition
• A comorbid health disorder that is not medically controlled in the opinion of the Investigator, and has the potential to: affect the safety of the subject throughout the study, impede the subject's ability to complete the duration of the study, influence the primary or secondary outcomes of the study
• Patient experiencing a symptomatic asthma exacerbation requiring systemic corticosteroids or hospitalization (>24 hours) within 4 weeks of randomization
• Infection requiring systemic antibiotics within 4 weeks of randomization (parenteral and/or oral antibiotics associated with surgery are allowed)
• Medical contraindication to receiving dupilumab: known hypersensitivity to dupilumab or any of its excipients, live vaccine administration within 30 days of randomization or during the study period, known helminth infection
• Unable to tolerate sinonasal irrigations
• Pregnancy, current lactation, or lack of effective contraception plan, as determined by the site investigator
• Initiation of allergen immunotherapy within 3 months prior to randomization or a plan to begin therapy or change its dose during the study period
• Immunosuppressive medication within 3 months prior to randomization and during the study period from randomization through the end of the study
• Receipt of any marketed or investigational biologic products (monoclonal or polyclonal antibody) within 6 months or 5 half-lives, whichever is longer, prior to randomization during the study period
• Previous use of dupilumab
• Receipt of immunoglobulin or blood products within 30 days prior to randomization
• Receipt of any investigational drug within 30 days or 5 half-lives, whichever is longer prior to randomization
• Scheduled systemic corticosteroid treatment during the study period (standardized corticosteroid taper associated with planned surgery is allowed)
• Receipt of leukotriene antagonists or modifiers for subjects who were not on a stable dose for > 30 days prior to randomization
• Concurrent enrollment in another investigational drug trial during the study period
• Patient involvement in the planning or conduct of the study
• Investigator assessment that the subject is unlikely to comply with study procedures
• Prior randomization in the present study
• Unable to undergo sinus surgery due to comorbid medical conditions

Where it is running

• Emory Hospital Midtown-Otolaryngology — Atlanta, Georgia, United States
• Ambulatory Surgery Center - Emory University Hospital — Atlanta, Georgia, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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