A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)

Официальное название

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab/LY3650150 in Participants With Chronic Rhinosinusitis With Nasal Polyps on Background Intranasal Corticosteroids

Обзор

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.

Вмешательства

• Препарат LY3650150
  Administered SC.
• Препарат Placebo
  Administered SC.
• Препарат Standard therapy for INCS
  Administered as intranasal spray.

Первичные конечные точки

• Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity [Срок оценки: Baseline, Week 24]
• Mean CFBL in Endoscopic Nasal Polyp Score (NPS) [Срок оценки: Baseline, Week 24]

Вторичные конечные точки (6)

• Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK) [Срок оценки: Baseline, Week 24]
• Mean change in Forced Expiratory Volume in 1 Second (FEV1) [Срок оценки: Baseline, Week 24]
• Mean CFBL in Severity of Loss of Smell [Срок оценки: Baseline, Week 24]
• Mean CFBL in Postnasal Drip [Срок оценки: Baseline, Week 24]
• Mean Change from Baseline by Visit for the 22-item Sino-nasal Outcome Test (SNOT-22) [Срок оценки: Baseline, Week 24]
• Mean Change from Baseline by Visit for the Nasal Peak Inspiratory Flow (NPIF) [Срок оценки: Baseline, Week 24]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 41 центр

• AllerVie Clinical Research — Birmingham
• University of Alabama at Birmingham — Birmingham
• Medovation Research — Huntsville
• Novak Clinical Research - Tucson - North La Cholla Boulevard — Tucson
• Keck Medicine of USC — Arcadia
• University of California, Irvine — Irvine
• ADCRC — La Mesa
• Ark Clinical Research — Long Beach
• … и ещё 33 центра

Япония · 35 центров

Список центров уточняется — проверьте первичный протокол.

Китай · 26 центров

• Peking University Third Hospital — Пекин
• Beijing Hospital — Пекин
• Beijing Tongren Hospital — Пекин
• The First Affiliated Hospital of Bengbu Medical College — Bengbu
• The Third Xiangya Hospital of Central South University — Чанша
• Sichuan Provincial People's Hospital — Чэнду
• The First People's Hospital of Foshan — Foshan
• The First Affiliated Hospital Of Fujian Medical University — Фучжоу
• … и ещё 18 центров

Польша · 11 центров

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South Korea · 10 центров

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Аргентина · 9 центров

• CEMLO - Centro de Especialidades Médicas Lobos — Beunos Aires
• Policonsultorio CEPIR — Buenos Aires
• Fundacion Respirar — Buenos Aires
• Fundacion CIDEA — Caba
• Centro de Investigaciones Clínicas - IESR - Rosario — Rosario
• Investigaciones en Patologías Respiratorias SRL — San Miguel de Tucumán
• CIMER-Centro Integral de Medicina Respiratoria — San Miguel de Tucumán
• Centro Respiratorio Infantil — Santa Fe
• … и ещё 1 центр

Германия · 8 центров

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Италия · 7 центров

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Румыния · 7 центров

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Испания · 7 центров

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Великобритания · 7 центров

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Болгария · 6 центров

• Multiprofile Hospital For Active Treatment Dr Tota Venkova A — Gabrovo
• Medical Center Medconsult Pleven OOD — Pleven
• Diagnostic-Consultative Centre Ascendent EOOD — Sofia
• Military Medical Academy - Multiprofile Hospital for Active Treatment - Sofia, — Sofia
• University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna — Sofia
• Multiprofile Hospital for Active treatment Trakia EOOD — Zagora

Португалия · 6 центров

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Мексика · 5 центров

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Канада · 4 центра

• St. Joseph's Hospital — Ontario
• CSAC — Québec
• The Gordon and Leslie Diamond Health Care Centre — Vancouver
• St Paul's Sinus Centre — Vancouver

Дания · 4 центра

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Бельгия · 3 центра

• Pneumocare — Erpent
• UZ Gent — Ghent
• Cliniques Universitaires Saint-Luc Avenue Hippocrate 10 — Woluwe-Saint-Lambert

Финляндия · 2 центра

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Венгрия · 2 центра

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Тайвань · 2 центра

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Идентификаторы

NCT: NCT06338995 · 18790 · J2T-MC-KGBU · 2023-508760-29-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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