Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 4: testing Biologic Agents for Chronic Sinusitis
The prevalence of Chronic Sinusitis with Nasal Polyps (CRSwNP) in the United States is estimated at roughly 4%, which equates to over 13 million Americans. Until recently, the only medical treatment options available for patients with CRSwNP were corticosteroids, with surgery reserved for medical failure.
Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Biologic Agents. The registry lists allocation as randomized. The prevalence of Chronic Sinusitis with Nasal Polyps (CRSwNP) in the United States is estimated at roughly 4%, which equates to over 13 million Americans.
They plan to enroll about 504 people at 5 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
SMART Use of Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Interventions: Biologic Agents
Primary outcome (registry wording): Disease-Specific Quality of Life
Who it is for (from inclusion criteria)
Ages 18 Years to any
Confirmed diagnosis of chronic rhinosinusitis with nasal polyposis using ICAR-21 (International Consensus Statement 20215) criteria
Bilateral nasal polyposis visible on sinonasal endoscopy
Nasal polyp score \> 5
Baseline SNOT-22 total score \> 30
Patient elects biologic therapy for the management of CRSwNP
Capable of receiving all 3 biologic therapy medications
Treatment with intranasal mometasone ≥200 μg. once daily (or equivalent of another intranasal corticosteroid) for 1-month prior to baseline visit
Who the registry excludes
Endoscopic sinus surgery within 6-months preceding enrollment / randomization
Oral corticosteroid use within 30-days preceding enrollment / randomization
Serum IgE level outside the dosing range for omalizumab (i.e., \<30 IU/ml. or a weight-based dose with insufficient data to determine dose as per FDA dosing chart)
Comorbid atopic dermatitis, urticaria, or any other condition that would require a specific biologic per the standard of care
Currently pregnant or plan to become pregnant within the 6 months after enrollment / randomization
Any previous treatment with any of the 3 biologic medications
Comorbid cystic fibrosis, CVID, or ciliary dyskinesia
We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled.
This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.
This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06824649?
Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06824649?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.