A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis

Official title

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

Overview

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

• Drug CHF10067
  Dose 1 CHF10067 Intravenous (IV) infusion
• Drug CHF10067
  Dose 2 CHF10067 IV infusion
• Other Placebo
  Placebo IV infusion

Primary outcome measures

• Primary Outcome Measure: Absolute change from baseline in ppFVC (percent predicted forced vital capacity) at Week 24. [Time frame: At Week 24]

Secondary outcome measures (11)

• 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 [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 [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]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

North Macedonia · 1 center

• PHI University Clinic of Pulmonology and Allergology — Skopje

Identifiers

NCT: NCT07516951 · CLI-10067AA1-02 · 2024-514246-37-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗