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
- Ferrara, Foggia, Milan, Modena, Monza, Padova, Rome, Siena, and Verona, ItalySee the 10 sites
- Phase
- Phase 2
Where in Italy
- University Hospital Of FerraraFerrara, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, ItalyNot yet recruiting
- ASST Fatebenefratelli SaccoMilan, ItalyNot yet recruiting
- Azienda Socio Sanitaria Territoriale Santi Paolo E CarloMilan, ItalyNot yet recruiting
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyNot yet recruiting
- Fondazione IRCCS San Gerardo dei TintoriMonza, ItalyNot yet recruiting
- Azienda Ospedaliera di PadovaPadova, ItalyNot yet recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria SeneseSiena, ItalyNot yet recruiting
- Centro Ricerche Cliniche di Verona s.r.l.Verona, ItalyNot 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?
Trial 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.