A Phase IIb, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Zampilimab in Participants with Idiopathic Pulmonary Fibrosis

Trial ID: 2024-514246-37-00
Protocol: CLI-10067AA1-02
Sponsor: Chiesi Farmaceutici S.p.A.

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Diseases & Conditions

Idiopathic pulmonary fibrosis

Objectives

The primary objective of this study is to evaluate the efficacy of two dose strengths of zampilimab in patients with idiopathic pulmonary fibrosis, specifically measuring the change from baseline in percent predicted forced vital capacity (ppFVC) at Week 24 compared to placebo. 5

The secondary objectives include:

Evaluation of additional lung function parameters, health status, safety, and tolerability. 3, 4, 5, 13
Assessment of pharmacokinetic variables following repeated administration. 6

Participants

This study involves 140 participants diagnosed with idiopathic pulmonary fibrosis. The study population consists of male and female patients aged 40 years or older with a life expectancy of at least one year. Inclusion requires a body weight of at least 45 kg and a diagnosis confirmed by high-resolution computed tomography according to established clinical guidelines. Essential pulmonary function parameters include a forced vital capacity of at least 45% of the predicted normal value and a forced expiratory volume in one second to FVC ratio of 0.7 or greater. Additionally, the diffusing capacity of the lung for carbon monoxide must be at least 25% of the predicted normal value, and peripheral capillary oxygen saturation must exceed 90% during a maximum oxygen flow of 4 L/min via nasal cannula.

Plans and Procedures

This Phase IIb, multicentre, randomised, double-blind, placebo-controlled, three-arm parallel-group study is designed to evaluate the efficacy, safety, and tolerability of zampilimab in participants with idiopathic pulmonary fibrosis. The primary objective is to assess the change from baseline in percent predicted forced vital capacity (ppFVC) at Week 24. Participants will receive either two different dose strengths of zampilimab via intravenous infusion or a placebo consisting of 0.9% sodium chloride aqueous solution. The study includes a screening period to confirm the diagnosis through high-resolution computed tomography and to assess lung function parameters, such as diffusing capacity of the lung for carbon monoxide (DLCO) and forced vital capacity (FVC). Following the initial phase, an optional 24-week double-blind, placebo-controlled extension phase is available. Clinical assessments and efficacy evaluations are scheduled at various intervals, including Weeks 0, 6, 12, 18, 24, and 30. The total duration of participant involvement depends on the completion of the core study and the optional extension.

Treatment

The experimental medication consists of zampilimab, provided as a solution for infusion. The administration is conducted via intravenous infusion at a dose of 3000 mg.

The control group receives a placebo consisting of 0.9% sodium chloride aqueous solution for intravenous infusion.

Efficacy

The efficacy of zampilimab in participants with idiopathic pulmonary fibrosis is evaluated by measuring the change from baseline in the percent predicted forced vital capacity (ppFVC). This primary endpoint is assessed at Week 24.

Secondary efficacy assessments are conducted at Weeks 0, 6, 12, 18, 24, and 30, as well as from Week 0 through Week 21.

Inclusion and Exclusion Criteria

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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 HRCT(High-resolution computed tomography) ≤6 months prior to screening, reviewed by central reading, should be used to confirm the diagnosis.
Lung function: Forced vital capacity (FVC) ≥45% of predicted normal value and a ratio of forced expiratory volume in the first second/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% when the maximum oxygen flow is 4 L/min by standard nasal cannula.

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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 #5 [Diagnosis of IPF]), reviewed by central reading, shows the presence of emphysema ≥50% 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 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.
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 Igs, or murine monoclonal antibodies.

Trial Status by Country

Country	Status	Start of Recruitment	Planned Patients
Belgium	Not Yet Recruiting	01 Jan 2026	6
Bulgaria	Not Yet Recruiting	01 Jan 2026	8
Czechia	Not Yet Recruiting	01 Jan 2026	7
France	Not Yet Recruiting	01 Jan 2026	14
Germany	Not Yet Recruiting	01 Jan 2026	11
Italy	Not Yet Recruiting	01 Jan 2026	14
The Netherlands	Not Yet Recruiting	01 Jan 2026	—
Poland	Not Yet Recruiting	01 Jan 2026	8
Portugal	Not Yet Recruiting	01 Jan 2026	7
Romania	Not Yet Recruiting	01 Jan 2026	8