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

PHASE3TerminatedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

October 26, 2023

Primary Completion Date

July 10, 2024

Study Completion Date

July 10, 2024

Conditions
Allergic Fungal Rhinosinusitis
Interventions
DRUG

Dupilumab

Dupilumab will be administered subcutaneously at a dose of 300 milligrams (mg) in a 2 milliliter (mL) solution every 2 weeks until the end of treatment (EOT) at Week 52. Participants will receive a total of 26 doses.

DRUG

Placebo

A placebo to match dupilumab will be administered subcutaneously every 2 weeks until the end of treatment (EOT) at Week 52. Participants will receive a total of 26 doses.

DRUG

Intranasal Corticosteroid Sprays (INCS)

All participants will undergo standardized background therapy with intranasal corticosteroid sprays (INCS) per standard of care (SoC). This will continue throughout the entire study. Participants either receive fluticasone propionate or mometasone furoate.

Trial Locations (3)

30308

Emory Hospital Midtown-Otolaryngology, Atlanta

30322

Ambulatory Surgery Center - Emory University Hospital, Atlanta

77030

University of Texas Health Science Center at Houston, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

Emory University

OTHER

NCT05545072 - Add-on Dupilumab for AFRS as Postoperative Therapy (ADAPT) | Biotech Hunter | Biotech Hunter