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

Conditions

• Allergic Fungal Rhinosinusitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dupilumab — DRUG
  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.
• Placebo — DRUG
  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.
• Intranasal Corticosteroid Sprays (INCS) — DRUG
  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.

Study Details

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 Dates

Start date

Oct 26, 2023

Status verified

May 2025

Primary completion

Jul 10, 2024

Completion

Jul 10, 2024

Study Design

Enrollment

5 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dupilumab
  Participants receiving dupilumab for 52 weeks following surgery for allergic fungal rhinosinusitis (AFRS).
• Placebo Comparator: Placebo
  Participants receiving a placebo to match dupilumab for 52 weeks following surgery for allergic fungal rhinosinusitis (AFRS).

Primary Outcome Measure

Modified Lund-Kennedy (mLK) Score [ Time Frame: Baseline and End of Treatment at Week 52 ]

Locations (3)

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