Idiopathic Pulmonary Fibrosis
Conditions
Keywords
IPF
Brief summary
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
DRUGCHF10067
Dose 1 CHF10067 Intravenous (IV) infusion
OTHERPlacebo
Placebo IV infusion
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) The Investigational Medicinal Product (IMP) is blinded for the participant, investigators, and the sponsor. At the study site an unblinded pharmacist (or designee) will prepare the IMP and an unblinded clinical research associate will check the IMP related documentation Unblinded Sponsor and Clinical Research organization's Study Managers and Clinical Supplies representative will be also assigned.
Intervention model description
Study will include a screening period of 6 weeks (including prescreening), a treatment period of 21 weeks (with evaluation of primary variable at Week 24), and a follow-up period of 9 weeks after the last dose or the discontinuation of study treatment.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measure: Absolute change from baseline in ppFVC (percent predicted forced vital capacity) at Week 24. | At Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute change from baseline in ppFVC at Weeks 6, 12, 18, and 30 | At Weeks 6, 12, 18, and 30 | — |
| Relative change from baseline in ppFVC at Week 24 and at Weeks 6, 12, 18, and 30 | At Weeks 6, 12, 18, 24 and 30 | — |
| Categorical absolute change from baseline in ppFVC at Week 24 and at Weeks 6, 12, 18, and 30 (5 dichotomous thresholds: -10%, -5%, 0%, 5%, and 10%) | At Weeks 6, 12, 18, 24 and 30 | — |
| Categorical relative change from baseline in ppFVC at Week 24 and at Weeks 6, 12, 18, and 30 (5 dichotomous thresholds: -10%, -5%, 0%, 5%, and 10%) | At Weeks 6, 12, 18, 24 and 30 | — |
| Rate of decline in ppFVC over 24 weeks | Up to 24 weeks | — |
| Absolute and relative change from baseline in FVC (forced vital capacity) milliliter (mL) at Week 24 and at Weeks 6, 12, 18, and 30 | At Weeks 6, 12, 18, 24 and 30 | — |
| Categorical absolute change from baseline in FVC (mL) at Week 24 and at Weeks 6, 12, 18, and 30 (5 dichotomous thresholds: -200 mL, -100 mL, 0 mL, 100 mL, and 200 mL) | At Weeks 6, 12, 18, 24 and 30 | — |
| Rate of decline in FVC (mL) over 24 weeks | Up to 24 Weeks | — |
| Change from baseline in the Living with Pulmonary Fibrosis (L-PF) questionnaire at Week 12 and at Week 24 | At Weeks 12 and 24 | L PF is a patient-reported questionnaire designed to assess health-related quality of life in participants with progressive fibrosing interstitial lung disease (ILD). The questionnaire comprises two distinct modules: L PF symptoms (23 items) and L PF impacts (21 items). The symptoms module assesses shortness of breath, cough, and fatigue over the past 24 hours. The impacts module assesses multiple aspects of health-related quality of life with a recall period of one week. Scores range from 0 to 100, with higher scores indicating worse symptoms and poorer quality of life. A negative change from baseline indicated better symptoms and better quality of life. |
| Change from baseline in specific modules of the L-PF questionnaire (symptoms and impact) and within the symptom modules of specific domains (shortness of breath, cough, and fatigue) at Week 12 and at Week 24 | At Weeks 12 and 24 | L PF is a patient-reported questionnaire designed to assess health-related quality of life in participants with progressive fibrosing ILD. The questionnaire comprises two distinct modules: L PF symptoms (23 items) and L PF impacts (21 items). The symptoms module assesses shortness of breath, cough, and fatigue over the past 24 hours. The Impacts module assesses multiple aspects of health-related quality of life with a recall period of one week. Scores range from 0 to 100, with higher scores indicating worse symptoms and poorer quality of life. A negative change from baseline indicated better symptoms and quality of life. |
| CHF10067 concentrations at each visit (Week 0 to Week 21) | From Week 0 up to Week 21 | — |
Countries
North Macedonia, United States
Contacts
CONTACTChiesi Clinical Trial Info
PRINCIPAL_INVESTIGATORVincent COTTIN
Louis Pradel Hospital - Lyon, FRANCE
Outcome results
None listed