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NCT06461949
Study of Dupilumab 300 mg Every Other Week After Endoscopic Sinus Surgery in Patients With Allergic Fungal Rhinosinusitis (AFRS) on a Background Therapy With Intranasal Corticosteroid Spray
Phase 3 trial testing Dupilumab in Allergic Fungal Rhinosinusitis (AFRS). Withdrawn.
17 July 2024
Quick facts
| Lead sponsor | National Institute on Deafness and Other Communication Disorders (NIDCD) |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Start date | 17 July 2024 |
| Primary completion | 17 July 2024 |
| Estimated completion | 17 July 2024 |
Drugs / interventions tested
- Dupilumab (DUPILUMAB) — full drug profile →
Conditions studied
- Allergic Fungal Rhinosinusitis (AFRS) — all drugs for Allergic Fungal Rhinosinusitis (AFRS) →
- Chronic Rhinosinusitis (CRS) — all drugs for Chronic Rhinosinusitis (CRS) →
- Asthma — all drugs for Asthma →
- Nasal Polyps — all drugs for Nasal Polyps →
Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Who can join
Adults 18 to 99, any sex, with Allergic Fungal Rhinosinusitis (AFRS) or Chronic Rhinosinusitis (CRS). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Allergic fungal rhinosinusitis (AFRS) is a severe type of sinus infection. People with AFRS develop heavy mucus and growths called polyps that apply pressure to the sinuses and block their breathing. Surgery can remove the polyps, but they often grow back. Researchers want to test an approved drug they believe may help people with AFRS. Objective: To test a drug (Dupilumab) in people with AFRS. Eligibility: People aged 18 years or older with suspected AFRS who are scheduled to undergo surgery for nasal polyps. Design: Participants will have several tests before their surgery. They will have imaging scans of their sinuses. They will have an endoscopic exam: A tube with a camera and a light will be inserted into their sinuses. They may give blood and mucus samples. They will have standard treatment with nasal sprays for 2 to 6 weeks before their surgery. Excess nasal tissue removed during the surgery will be collected for research. Then they will begin treatment with the study drug. Dupilumab is injected under the skin. Some participants will receive the study drug. Some will receive a placebo injections. The placebo injections are just like the study drug but contain no medicine. Participants will not know which injections they are getting. All participants will administer the injections to themselves at home. They will do this every 2 weeks for 1 year after the surgery. They will have a clinic visit 16 weeks after surgery. Participants will have follow-up for 12 weeks after treatment ends.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06461949
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06461949 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute on Deafness and Other Communication Disorders (NIDCD)
- Last refreshed: 25 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06461949.
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