Testing 2 doses of zampilimab in people with idiopathic pulmonary fibrosis
Tests 2 doses of zampilimab against placebo in adults with idiopathic pulmonary fibrosis.
Plain-language title generated from the registry record
Registry title: A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis
Key facts
- Where
- Haskovo and Sofiya, BulgariaSee the 2 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 or older with idiopathic pulmonary fibrosis (IPF), a lung disease that scars the lungs. It tests two doses of CHF10067 (zampilimab) against placebo.
- Age
- 40 years or older
- Sex
- Men and women can join.
- Disease stage
- IPF diagnosed within the last 8 years. Lung function tests must meet set minimums: FVC at least 45% and DLCO at least 25% of predicted normal.
- Earlier treatment
- People cannot join if they are being treated now, or were treated within the last 48 weeks, with cytotoxic or immunosuppressant/modulator drugs. High-dose steroids used for more than 10 days also rule people out.
Main reasons for not taking part
- Lung infection in the last 4 weeks or a recent acute flare-up of IPF
- Active lung cancer or a history of lung cancer
- Emphysema of 20% or more, or more emphysema than fibrosis
- End-stage disease expected to need an organ transplant within 6 months
- Coeliac disease, or known allergy to the study drug ingredients or to antibody-based medicines
Read by machine on 9 November 2026.
Where in Bulgaria
- Medical Center Pulmo - 2018 EOODHaskovo, BulgariaNot yet recruiting
- Diagnostics And Consultation Center Convex Ltd.Sofiya, BulgariaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Chiesi Farmaceutici S.p.A.
- Trial code
- NCT07516951EU 2024-514246-37-00
- Record updated
- 16 October 2026
- Original 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).Read full original descriptionShow less
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
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.
Inclusion: 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: 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; 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; Participant with a documented diagnosis of coeliac disease; Lung cancer: Active diagnosis or history of lung cancer; 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; 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; 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.