Estudio de fase 3, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad de lebrikizumab/LY3650150 en participantes con rinosinusitis crónica con pólipos nasales en tratamiento de base con corticosteroides intranasales

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06338995Tipo: INTERVENTIONALInicio: 29 de abr de 2024Fin estimado: 1 de mar de 2028

Resumen

El objetivo principal de este estudio es evaluar la eficacia y seguridad de lebrikizumab en participantes con rinosinusitis crónica y pólipos nasales tratados con corticosteroides intranasales. El estudio tendrá una duración de aproximadamente 18 meses.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP).
Prior treatment with systemic corticosteroids (SCS) within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for NP, or both.
Endoscopic bilateral NPS score of at least 5 out of 8, with a minimum score of 2 in each nasal cavity performed at screening and baseline.
Ongoing symptoms for at least 8 weeks prior to study entry (screening), including:
Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening and a weekly average severity score of at least 1 (range 0 to 3) at randomization, and
At least one other symptom, such as partial loss of smell (hyposmia), total loss of smell (anosmia), or anterior or posterior rhinorrhea.
Have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.
Adolescent participants ≥12 to \<18 years of age and weighing ≥40 kg at time of Visit 1.

Criterios de exclusión

Have received a dose of lebrikizumab.
Have received treatment with any rescue medication and/or have the need for surgery for NP during screening and/or run-in period.
Allergen immunotherapy (subcutaneous immunotherapy \[SCIT\]/sublingual immunotherapy \[SLIT\]) initiated within 6 months prior to screening, that is not on a stable dose (3 months prior to screening).
Has received a biologic treatment approved for use in CRSwNP, asthma, or AD, even if administered to treat a different condition, within 4 months or 5 half-lives, whichever is longer, prior to screening.
Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit:
B cell-depleting biologics, including rituximab, within 6 months.
other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
Systemic immunosuppressants within 4 weeks prior to baseline.
Have had any sinus intranasal surgery (including nasal polypectomy) within 6 months prior to screening
Have had prior sino-nasal surgery or sinus surgery changing lateral wall structure of the nose making it difficult to assess endoscopic NPS
Have a presence of any of the following conditions that may impact the assessment of endpoints at screening or baseline:
Nasal septal deviation occluding at least one nostril.
Antrochoanal polyps.
Acute sinusitis, acute nasal infection, or acute upper respiratory infection.
Ongoing rhinitis medicamentosa.
Presence of another diagnosis associated with NP (ie, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, primary ciliary dyskinesia, cystic fibrosis). Note: for adolescents, documentation for ruling out cystic fibrosis and primary ciliary dyskinesia is required.
A nasal cavity tumor (malignant or benign).
Evidence of fungal rhinosinusitis.
Have anosmia from COVID or any reason other than CRSwNP.
Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal) at screening.
Female participant who is pregnant, breastfeeding, or is planning to become pregnant, or to breastfeed during the study.

Intervenciones

drug

LY3650150

Administered SC.

drug

Placebo

Administered SC.

drug

Standard therapy for INCS

Administered as intranasal spray.

Ubicaciones

CEMLO - Centro de Especialidades Médicas Lobos

Beunos Aires, Argentina

RECRUITING

Fundacion Respirar

Buenos Aires, Argentina

RECRUITING

Centro Platense en Investigaciones Respiratorias - CEPIR

Buenos Aires, Argentina

NOT_YET_RECRUITING

Fundacion CIDEA

Caba, Argentina

NOT_YET_RECRUITING

Centro de Investigaciones Clínicas - IESR - Rosario

Rosario, Argentina

RECRUITING

Investigaciones en Patologías Respiratorias SRL

San Miguel de Tucumán, Argentina

RECRUITING

CIMER-Centro Integral de Medicina Respiratoria

San Miguel de Tucumán, Argentina

NOT_YET_RECRUITING

Centro Respiratorio Infantil

Santa Fe, Argentina

NOT_YET_RECRUITING

CARE - Centro de Alergia y Enfermedades Respiratorias

Villa Crespo, Argentina

RECRUITING

Patrocinadores

PrincipalEli Lilly and Company

Contactos

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

LillyTrials@Lilly.com 1-317-615-4559

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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