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A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
510 patients around the world
Available in Argentina, United States
Eli Lilly and Company
9Research sites
510Patients around the world
This study is for people with
Rhinosinusitis
Chronic Rhinosinusitis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.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.
- 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) or may require a dose change during study.Prior or current biologic treatment for CRSwNP and/or asthma including but not limited to omalizumab, dupilumab, mepolizumab, reslizumab, and benralizumab.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).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.
Sites
Fundación CIDEA - Buenos Aires
Centro de Investigaciones Clínicas - IESR - Rosario, Santa Fe
CEPIR - La Plata
Instituto de Investigaciones en Patologías Respiratorias SRL - Tucumán
Centro Integral de Medicina Respiratoria (CIMER) - Tucumán
Centro Respiratorio Infantil S.A. - Rosario
CEMLO Centro de Especialidades Médicas Lobos
Centro de Alergia y Enfermedades Respiratorias - Buenos Aires
Fundación Respirar
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Chronic Rhinosinusitis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06338995
