El propósito principal del estudio es evaluar la eficacia de brensocatib a dosis de 10 y 40 miligramos (mg) una vez al día en comparación con placebo en la mejoría de los síntomas clínicos de la rinosinusitis crónica sin pólipos nasales (RSCsPN).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Participants who have at least a 12-week history before Screening Visit of CRSsNP and confirmed by endoscopy at Visit 1 (Screening).
Participants must have a NCS of ≥2 at Visit 1 (Screening Visit) and Visit 2 (Baseline; average score in the week prior to randomization).
Participants must have sTSS (nasal congestion \[NC\], anterior/posterior rhinorrhea, facial pain/pressure) ≥5 at Visit 1 (Screening) and at Visit 2 (Baseline; average score in the week prior to randomization).
Participants who have at least 1 of the 3 following features:
Previous sinonasal surgery for CRS, including but not limited to fenestrated endoscopic sinus surgery and balloon sinuplasty.
Received medical treatment with systemic corticosteroids (SCS) to treat symptoms of CRS as defined by any dose and duration within 1 year of Screening Visit or intolerance/contraindication to SCS.
Received a course of antibiotics to treat symptoms of CRS within 1 year before the Screening Visit.
Participants who have a blood eosinophil count ≤750 cells/microliter (μL) at Visit 1 (Screening).
Participants who have bilateral inflammation of paranasal sinuses in the CT scan performed during Screening and bilateral ethmoid and/or maxillary opacification before randomization as confirmed by the central reader.
Participants who have a SNOT-22 score of ≥20 at Visit 1 (Screening) and Visit 2 (Baseline).
Participants who have received a stable daily dose regimen of MFNS for at least 4 weeks before Visit 2 (Baseline).

Criterios de exclusión

Diagnosis of unilateral or bilateral chronic rhinosinusitis with nasal polyps (CRSwNP).
Clinical diagnosis of cystic fibrosis (CF) or primary ciliary dyskinesia.
Scheduled sinus surgery at any time during the study.
Participants who have had nasal surgery within 4 weeks before Visit 1 (Screening) and during the Screening Period.
Significant oral maxillofacial structural abnormalities or severe septal deviation.
Participants with radiological suspicion or confirmed invasive fungal rhinosinusitis, odontogenic sinusitis, osteomas, or nasal tumors.
Participants with acute change in symptoms consistent with acute rhinosinusitis.
Participants with seasonal allergic rhinitis whose symptoms coincide with the treatment period of the study.
Participants with moderate to severe atopic dermatitis requiring treatment with high potency topical steroids or topical calcineurin inhibitors or biologics.
Clinical diagnosis of Papillon-Lefèvre syndrome.

Ubicaciones

ARG015

La Plata, Buenos Aires, Argentina

ARG001

La Plata, Buenos Aires, Argentina

ARG006

Lobos, Buenos Aires, Argentina

ARG005

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

ARG012

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

ARG011

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

ARG017

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

ARG013

San Rafael, Mendoza Province, Argentina

ARG007

Rosario, Santa Fe Province, Argentina

ARG010

Rosario, Santa Fe Province, Argentina

ARG004

Rosario, Santa Fe Province, Argentina

ARG009

San Miguel de Tucumán, Tucumán Province, Argentina

ARG002

Mar del Plata, Argentina

ARG014

Mendoza, Argentina

ARG003

Mendoza, Argentina

ARG016

Rosario, Argentina

ARG008

Santa Fe, Argentina

Estudio de fase 2b, aleatorizado, doble ciego, controlado con placebo, multicéntrico, de la eficacia y seguridad de brensocatib en participantes con rinosinusitis crónica sin pólipos nasales - Estudio BiRCh

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Brensocatib

Placebo

Mometasone furoate nasal spray (MFNS)

Ubicaciones

ARG015

ARG001

ARG006

ARG005

ARG012

ARG011

ARG017

ARG013

ARG007

ARG010

ARG004

ARG009

ARG002

ARG014

ARG003

ARG016

ARG008

Patrocinadores