A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis
Chiesi Farmaceutici S.p.A. · NCT07516951
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 40+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 240
- US sites recruiting
- 6
- Study start
- July 8, 2026
- Record last updated
- October 16, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: CHF10067; CHF10067; Placebo
Conditions: Idiopathic Pulmonary Fibrosis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
SEC Clinical Research LLC
Dothan, AL 36305
Site contact: Marvin Sexton
Pasadena Center for Medical Research, Inc
St. Petersburg, FL 33707
Site contact: Mohamed Ali
Hannibal Regional Healthcare System, Inc.
Hannibal, MO 63401
Site contact: Farah Humam
Clinical Research of Rock Hill
Rock Hill, SC 29732
Site contact: Michael Denenberg
Tennessee Comprehensive Lung and Sleep Center
Hendersonville, TN 37075
Site contact: Clyde Southwell
Premier Pulmonary Critical Care and Sleep Medicine, PA
Denison, TX 75020
Site contact: Sanober Kable
Study contacts (from the official record)
- Chiesi Clinical Trial Info · + 39 0521 2791 · Clinicaltrials_info@chiesi.com