Study of Dupilumab 300 mg Every Other Week After Endoscopic Sinus Surgery in Patients With Allergic Fungal Rhinosinusitis (AFRS) on a Background Therapy With Intranasal Corticosteroid Spray

NCT06461949 | Withdrawn Phase 3 FDA Drug

• 2 other identifiers: 10001856001856-DC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Allergic fungal rhinosinusitis (AFRS) is a severe type of sinus infection. People with AFRS develop heavy mucus and growths called polyps that apply pressure to the sinuses and block their breathing. Surgery can remove the polyps, but they often grow back. Researchers want to test an approved drug they believe may help people with AFRS. Objective: To test a drug (Dupilumab) in people with AFRS. Eligibility: People aged 18 years or older with suspected AFRS who are scheduled to undergo surgery for nasal polyps. Design: Participants will have several tests before their surgery. They will have imaging scans of their sinuses. They will have an endoscopic exam: A tube with a camera and a light will be inserted into their sinuses. They may give blood and mucus samples. They will have standard treatment with nasal sprays for 2 to 6 weeks before their surgery. Excess nasal tissue removed during the surgery will be collected for research. Then they will begin treatment with the study drug. Dupilumab is injected under the skin. Some participants will receive the study drug. Some will receive a placebo injections. The placebo injections are just like the study drug but contain no medicine. Participants will not know which injections they are getting. All participants will administer the injections to themselves at home. They will do this every 2 weeks for 1 year after the surgery. They will have a clinic visit 16 weeks after surgery. Participants will have follow-up for 12 weeks after treatment ends.

Conditions

Allergic Fungal Rhinosinusitis (AFRS); Chronic Rhinosinusitis (CRS); Asthma; Nasal Polyps

Keywords

Ethmoid tissue; Intranasal corticosteroids; Nasal polyps; Sinonasal inflammation; Lung Function; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Efficacy of Dupilumab

  -Control of sinonasal inflammation.-Prevention of nasal polyp recurrence after complete sinus surgery for AFRS.-Measured by change in the modified Lund-Kennedy (mLK) score.

  Change from baseline at 52 weeks

Secondary Outcomes (6)

• Effect of Dupilumab on Oral Corticosteroid Utilization

  Change from baseline at 52 weeks

• Prevention of Revision Surgery for AFRS

  Change from baseline at 52 weeks

• Secondary Objective Measures of Sinonasal Inflammation

  Change from baseline at 52 weeks

• Lower Airway Dysfunction in Participants with Asthma

  Change from baseline at 52 weeks

• Health-Related Quality of Life

  Change from baseline at 52 weeks

Study Arms (2)

Arm A:

EXPERIMENTAL

Treatment: Dupilumab 300 mg administered subcutaneously every two weeks for 52 weeks.

Drug: Dupilumab

Arm B:

PLACEBO COMPARATOR

Control: Placebo administered subcutaneously every two weeks for 52 weeks.

Drug: Dupilumab

Interventions

Dupilumab DRUG

Dupilumab (Dupixent) is a human monoclonal antibody administered via subcutaneous injection to treat various conditions such as Chronic Rhinosinusitis with Nasal Polyps, Asthma and Eosinophilic Esophagitis.

Arm A:; Arm B:

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Informed consent
• Participants must be capable of giving signed informed consent as listed in the informed consent form (ICF) and this protocol.
• ICF must be signed and dated prior to study specific procedures. Informed consent process is described further below.
• Age
• Participants aged \>=18 years at the time of signing the ICF.
• Types of subject and disease characteristics
• Participants 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 time of enrollment.
• A minimum CT Lund-MacKay score of \> 1 at time of enrollment.
• Suspected AFRS based on Bent and Kuhn criteria
• Participants must meet 3/5 criteria at time of enrollment
• Environmental atopy by skin or serum testing
• Nasal polyposis

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD): lead

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Allergic Fungal Sinusitis; Asthma; Nasal Polyps

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Joshua Levy, M.D.

  National Institute on Deafness and Other Communication Disorders (NIDCD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2024
• First Posted: June 17, 2024
• Study Start: July 17, 2024
• Primary Completion: July 17, 2024
• Study Completion: July 17, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Post study completion and as determined by NIDCD staff.