RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Chiesi Farmaceutici S.p.A. • ClinicalTrials.gov ID: NCT07516951

Registry updated: 2026-10-16

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Description

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.

Interventions

CHF10067 (Drug)
Dose 1 CHF10067 Intravenous (IV) infusion
CHF10067 (Drug)
Dose 2 CHF10067 IV infusion
Placebo (Other)
Placebo IV infusion

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 \<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.

Conditions

Idiopathic Pulmonary Fibrosis

Locations

SEC Clinical Research LLC — Dothan, Alabama, United States
Pasadena Center for Medical Research, Inc — St. Petersburg, Florida, United States
Hannibal Regional Healthcare System, Inc. — Hannibal, Missouri, United States
Clinical Research of Rock Hill — Rock Hill, South Carolina, United States
Tennessee Comprehensive Lung and Sleep Center — Hendersonville, Tennessee, United States
Premier Pulmonary Critical Care and Sleep Medicine, PA — Denison, Texas, United States
PHI University Clinic of Pulmonology and Allergology — Skopje, North Macedonia
Soon Chun Hyang University Bucheon Hospital — Bucheon-si, South Korea
Inje University Busan Paik Hospital — Busan, South Korea
Inje University Haeundae Paik Hospital — Busan, South Korea
Chonnam National University Hospital — Gwangju, South Korea
Kyung Hee University Hospital — Seoul, South Korea
Korea University Anam Hospital — Seoul, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital — Seoul, South Korea
Asan Medical Center — Seoul, South Korea
Seoul Metropolitan Government-Seoul National University Boramae Medical Center — Seoul, South Korea
Ajou University Hospital — Suwon, South Korea
Royal Papworth Hospital NHS Foundation Trust — Cambridge, United Kingdom
Royal Devon and Exeter Hospital - Royal Devon University Healthcare NHS Foundation Trust — Exeter, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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