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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Dose 1 CHF10067 Intravenous (IV) infusion
Dose 2 CHF10067 IV infusion
Placebo IV infusion
Hannibal Regional Healthcare System, Inc.
Hannibal, Missouri, United States
RECRUITINGPremier Pulmonary Critical Care and Sleep Medicine, PA
Denison, Texas, United States
RECRUITINGPHI University Clinic of Pulmonology and Allergology
Skopje, North Macedonia
RECRUITINGPrimary Outcome Measure: Absolute change from baseline in ppFVC (percent predicted forced vital capacity) at Week 24.
Time frame: At Week 24
Absolute change from baseline in ppFVC at Weeks 6, 12, 18, and 30
Time frame: At Weeks 6, 12, 18, and 30
Relative change from baseline in ppFVC at Week 24 and at Weeks 6, 12, 18, and 30
Time frame: 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%)
Time frame: 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%)
Time frame: At Weeks 6, 12, 18, 24 and 30
Rate of decline in ppFVC over 24 weeks
Time frame: 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
Time frame: 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)
Time frame: At Weeks 6, 12, 18, 24 and 30
Rate of decline in FVC (mL) over 24 weeks
Time frame: Up to 24 Weeks
Change from baseline in the Living with Pulmonary Fibrosis (L-PF) questionnaire at Week 12 and at Week 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.
Time frame: At Weeks 12 and 24
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
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.
Time frame: At Weeks 12 and 24
CHF10067 concentrations at each visit (Week 0 to Week 21)
Time frame: From Week 0 up to Week 21
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