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New treatment option for Idiopathic Pulmonary Fibrosis
Official title A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis
ClinicalTrials.gov ID: NCT07516951
What this study is testing
What is CHF10067?
CHF10067 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for idiopathic pulmonary fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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...
- 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...
- 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.
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Skopje, North Macedonia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Skopje, North Macedonia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.