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NCT07516951
A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis
Conditions: Idiopathic Pulmonary Fibrosis
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 240
Sponsor: Chiesi Farmaceutici S.p.A.
Location: Hannibal Regional Healthcare System, Inc. Hannibal Missouri
Summary
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.
Eligibility Criteria
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 ≥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).
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 \
Source: ClinicalTrials.gov (NCT07516951). StuddyBuddy aggregates publicly available trial information.