A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis

Официальное название

A Phase IIb, Multicentre, Randomised, Double Blind, Placebo Controlled, Three-arm Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability at Week 24 of 2 Doses of CHF10067 (Zampilimab),in Participants With Idiopathic Pulmonary Fibrosis

Обзор

The purpose of this study is to evaluate the efficacy, safety, and tolerability at Week 24 of 2 doses of CHF10067 (zampilimab) in participants with idiopathic pulmonary fibrosis (IPF). It is a phase IIb, multicentre, randomised, double-blind, placebo-controlled, three-arm parallel-group study. A total of 240 participants with IPF (Idiomatic Pulmonary Fibrosis) will be randomised in approximately 150 investigational sites in North and Latin America, Europe, Asia, and Oceania.

Вмешательства

• Препарат CHF10067
  Dose 1 CHF10067 Intravenous (IV) infusion
• Препарат CHF10067
  Dose 2 CHF10067 IV infusion
• Другое Placebo
  Placebo IV infusion

Первичные конечные точки

• Primary Outcome Measure: Absolute change from baseline in ppFVC (percent predicted forced vital capacity) at Week 24. [Срок оценки: At Week 24]

Вторичные конечные точки (11)

• Absolute change from baseline in ppFVC at Weeks 6, 12, 18, and 30 [Срок оценки: At Weeks 6, 12, 18, and 30]
• Relative change from baseline in ppFVC at Week 24 and at Weeks 6, 12, 18, and 30 [Срок оценки: At Weeks 6, 12, 18, 24 and 30]
• Categorical absolute change from baseline in ppFVC at Week 24 and at Weeks 6, 12, 18, and 30 (5 dichotomous thresholds: -10%, -5%, 0%, 5%, and 10%) [Срок оценки: At Weeks 6, 12, 18, 24 and 30]
• Categorical relative change from baseline in ppFVC at Week 24 and at Weeks 6, 12, 18, and 30 (5 dichotomous thresholds: -10%, -5%, 0%, 5%, and 10%) [Срок оценки: At Weeks 6, 12, 18, 24 and 30]
• Rate of decline in ppFVC over 24 weeks [Срок оценки: Up to 24 weeks]
• Absolute and relative change from baseline in FVC (forced vital capacity) milliliter (mL) at Week 24 and at Weeks 6, 12, 18, and 30 [Срок оценки: At Weeks 6, 12, 18, 24 and 30]
• Categorical absolute change from baseline in FVC (mL) at Week 24 and at Weeks 6, 12, 18, and 30 (5 dichotomous thresholds: -200 mL, -100 mL, 0 mL, 100 mL, and 200 mL) [Срок оценки: At Weeks 6, 12, 18, 24 and 30]
• Rate of decline in FVC (mL) over 24 weeks [Срок оценки: Up to 24 Weeks]
• Change from baseline in the Living with Pulmonary Fibrosis (L-PF) questionnaire at Week 12 and at Week 24 [Срок оценки: At Weeks 12 and 24]
• Change from baseline in specific modules of the L-PF questionnaire (symptoms and impact) and within the symptom modules of specific domains (shortness of breath, cough, and fatigue) at Week 12 and at Week 24 [Срок оценки: At Weeks 12 and 24]
• CHF10067 concentrations at each visit (Week 0 to Week 21) [Срок оценки: From Week 0 up to Week 21]

Критерии участия

Критерии включения

• Informed consent: Participant's written informed consent obtained prior to any study-related procedure.
• Sex and age: Male or female, of any race and ethnicity, aged ≥40 years with a life expectancy of at least 1 year at screening in the opinion of the Investigator.
• Body weight ≥45 kg.
• Diagnosis of IPF: Diagnosis as defined by the 2018 and 2022 American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Society Guidelines for a maximum 8 years before screening. The most recent High-resolution computed tomography (HRCT) ≤6 months prior to screening, reviewed by central reading, should be used to confirm the diagnosis.
• Lung function: FVC ≥45% of predicted normal value and a ratio of forced expiratory volume in the first second (FEV1)/FVC ≥0.7 at screening.
• Diffusing capacity of the lung for carbon monoxide (DLCO) corrected for haemoglobin ≥25% of predicted normal at screening.
• Oxygen saturation measured by pulse oximetry (peripheral capillary oxygen saturation \[SpO2\]) >90% at rest when the maximum oxygen flow is 4 L/min by standard nasal cannula or the equivalent oxygen delivery via reservoir nasal cannula (≤2 L/min).

Критерии исключения

• Participant with a documented diagnosis of coeliac disease.
• Low respiratory tract infection: Documented low respiratory tract infection in the last 4 weeks prior to screening or documented acute exacerbation of IPF (defined as acute worsening or development of dyspnoea typically <1 month duration;
• Lung cancer: Active diagnosis or history of lung cancer.
• Emphysema: HRCT (refer to inclusion criterion \[Diagnosis of IPF\]), reviewed by central reading, shows the presence of emphysema ≥20% or that the extent of emphysema is greater than the extent of fibrosis.
• Organ transplantation: End-stage fibrotic disease expected to require organ transplantation within 6 months from screening.
• Other medical conditions: Clinically relevant and uncontrolled pulmonary (including any non-IPF pulmonary diagnosis), cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, psychiatric disorders, active or untreated latent tuberculosis/tuberculosis infection that may interfere with the participant's ability to complete this study according to the Investigator's judgement.
• Any other comorbid non-IPF pulmonary condition that may impact FVC according to the Investigator's judgement. Emphysema is allowed, unless it meets the above exclusion criterion regarding emphysema.
• Participant currently treated, or been treated with cytotoxic and immunosuppressant/modulator drugs within 48 weeks prior to screening. Systemic (IV, intramuscular, or oral) corticosteroids prednisone- equivalent dose of >10 mg/day used for >10 days.
• Hypersensitivity: Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation or any other substance used in the study.
• History of allergic or anaphylactic reaction to human, humanised, chimeric immunoglobulins (Igs), or murine monoclonal antibodies.

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

North Macedonia · 1 центр

• PHI University Clinic of Pulmonology and Allergology — Skopje

Идентификаторы

NCT: NCT07516951 · CLI-10067AA1-02 · 2024-514246-37-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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