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

RecruitingPhase 2Ages 40 Years - anyAllChiesi Farmaceutici S.p.A.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 โ‰ฅ40 years with a life expectancy of at least 1 year at screening in the opinion of the Investigator. * Body weight โ‰ฅ45 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) โ‰ค6 months prior to screening, reviewed by central reading, should be used to confirm the diagnosis. * Lung function: FVC โ‰ฅ45% of predicted normal value and a ratio of forced expiratory volume in the first second (FEV1)/FVC โ‰ฅ0.7 at screening. * Diffusing capacity of the lung for carbon monoxide (DLCO) corrected for haemoglobin โ‰ฅ25% 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 (โ‰ค2 L/min). Exclusion Criteria: * 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 โ‰ฅ20% 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.
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What it tests

  • CHF10067
  • CHF10067
  • Placebo
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Where

19 sites
SEC Clinical Research LLC
Dothan, United States
Pasadena Center for Medical Research, Inc
St. Petersburg, United States
Hannibal Regional Healthcare System, Inc.
Hannibal, United States
Clinical Research of Rock Hill
Rock Hill, United States
Tennessee Comprehensive Lung and Sleep Center
Hendersonville, United States
Premier Pulmonary Critical Care and Sleep Medicine, PA
Denison, United States
PHI University Clinic of Pulmonology and Allergology
Skopje, North Macedonia
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, South Korea

โ€ฆand 11 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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