Dupilumab for Allergic Fungal Rhinosinusitis

Recruiting at 112 trial locations

Overseen By Trial Transparency email recommended (Toll free number for US & Canada)

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi

Must not be taking: Biologics, Immunosuppressants, Anti-IgE, others

Disqualifiers: Nasal tumors, Tuberculosis, Immunodeficiency, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

62 Participants Needed

Trial Summary

What is the purpose of this trial?

Primary Objective: * To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) Secondary Objectives: * To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) at Week 24 * To assess the efficacy of dupilumab to reduce the need for rescue treatments * To evaluate the efficacy of treatment with dupilumab in improving symptoms in AFRS * To evaluate the efficacy of dupilumab to reduce nasal polyp formation in participants with AFRS * To evaluate the efficacy of dupilumab in improving overall symptom severity and quality of life in AFRS * To evaluate the efficacy of dupilumab in improving sense of smell in participants with AFRS * To explore the effect of dupilumab as assessed by three-Dimensional CT volumetric measurement of the paranasal sinuses * To evaluate the safety and tolerability of dupilumab when administered to participants with AFRS * To evaluate the pharmacokinetics (PK) of dupilumab in participants with AFRS * To characterize the effect of dupilumab on total IgE and specific IgE * To assess immunogenicity to dupilumab in participants with AFRS

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

This trial is for individuals at least 6 years old with Allergic Fungal Rhinosinusitis (AFRS), confirmed by specific allergy tests, nasal polyps seen in endoscopy, and characteristic CT scans. They must weigh over 15 kg and not have had sinus surgery or used certain nasal treatments recently. People with fungal invasion of sinus tissue, immune deficiencies, active infections requiring systemic treatment, hypersensitivity to dupilumab or its components are excluded.

Inclusion Criteria

I have been diagnosed with AFRS, confirmed by specific tests and scans.

This criterion is incomplete. If you can provide more information, I'd be happy to help rewrite it for you.

I have sinus issues, weigh at least 15 kg, and meet specific nasal and sinus criteria.

Exclusion Criteria

I had sinus surgery, including polyp removal, within the last 6 months.

I do not have active tuberculosis or a related infection, or if I had it, it's been fully treated.

I have or might have a parasite infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dupilumab or placebo every 2 or 4 weeks based on weight for 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Dupilumab SAR231893

Trial Overview The study is testing the effectiveness of Dupilumab in reducing sinus blockage due to AFRS compared to a placebo. It will also assess if Dupilumab can lessen the need for other treatments, improve symptoms and quality of life, reduce nasal polyp formation, enhance smell sense and evaluate safety over a period up to Week 24.

Participant Groups

Group I: Dupilumab Experimental Treatment 1 Intervention

Dupilumab administered every 2 or 4 weeks based on weights

Group II: Matching placebo Placebo Group 1 Intervention

Placebo administered every 2 or 4 weeks based on weights

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School