Dupilumab in Allergic Fungal Rhinosinusitis (AFRS) (LIBERTY-AFRS-AI)

Conditions

• Allergic Fungal Rhinosinusitis

Eligibility Criteria

Sex

ALL

Age

6 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Dupilumab SAR231893 — DRUG
  Pharmaceutical form:Injection solution Route of administration: Subcutaneous
• Placebo — DRUG
  Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Study Details

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

Key Dates

Start date

Dec 1, 2020

Status verified

Nov 2025

Primary completion

Dec 14, 2024

Completion

Mar 7, 2025

Study Design

Enrollment

62 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dupilumab
  Dupilumab administered every 2 or 4 weeks based on weights
• Placebo Comparator: Matching placebo
  Placebo administered every 2 or 4 weeks based on weights

Primary Outcome Measure

Change From Baseline to Week 52 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score [ Time Frame: Baseline (Day 1) and Week 52 ]

Locations (11)

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