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NCT05545072 · ClinicalTrials.gov registry record · Phase 3
Add-on Dupilumab for AFRS as Postoperative Therapy (ADAPT)
A Phase 3 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 5
- Enrollment target
NCT05545072: Clinical Trial Phase 3 study, sponsored by Emory University.
NCT05545072 is a Phase 3 study that was terminated before completion, run by Emory University. The registered enrollment target is 5 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05545072, a Phase 3 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 5 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The efficacy of dupilumab in controlling sinonasal inflammation and preventing nasal polyp recurrence after complete sinus surgery for allergic fungal rhinosinusitis (AFRS) is assessed by using the modified Lund-Kennedy score. The modified Lund-Kennedy score (mLK) is a validated measure of sinonasal inflammation, as evaluated by means of nasal endoscopy. The composite score ranges from 0 to 12, with an increasing score representing worsening inflammation among three separate findings (Nasal poly
Interventions
- DRUG Placebo
- DRUG Dupilumab
- DRUG Intranasal Corticosteroid Sprays (INCS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2023-10-26 |
| Est. Completion | 2024-07-10 |
| Phase | Phase 3 |
Why NCT05545072 stopped before completion
NCT05545072 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05545072 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05545072 about?
NCT05545072 is a clinical study titled "Add-on Dupilumab for AFRS as Postoperative Therapy (ADAPT)". 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 or...
What is the current status of trial NCT05545072?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 5 participants. The study started on 2023-10-26. Estimated completion is 2024-07-10.
What interventions are being tested in trial NCT05545072?
The interventions under investigation include: Placebo (DRUG), Dupilumab (DRUG), Intranasal Corticosteroid Sprays (INCS) (DRUG).
Who is sponsoring clinical trial NCT05545072?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05545072's enrollment target sits among peer trials
5 1997th of 2000 higher than 3 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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