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

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), With an Optional 24-week Double Blind, Placebo Controlled Extension Phase in Participants With Idiopathic Pulmonary Fibrosis

The purpose of this study is to evaluate the efficacy, safety, and tolerability at Week 24 (Part A) of 2 doses of CHF10067 (zampilimab), with an optional 24-week double-blind, placebo-controlled extension phase (Part B) in participants with idiopathic pulmonary fibrosis.

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. The optional extension phase (Part B) is only applicable to the European Union and Macedonia.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: CHF10067; Drug: CHF10067; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chiesi Clinical Trial info; Phone Number: + 39 0521 2791; Email: clinicaltrials_info@chiesi.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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% 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 #5 [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 Igs (immunoglobulins), or murine monoclonal antibodies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm A; CHF10067 (Test Dose 1)	Drug: CHF10067; Dose 1 CHF10067 Intravenous infusion; Drug: CHF10067; Dose 2 CHF10067 Intravenous infusion
Experimental: Treatment arm B; CHF10067 (Test Dose 2)	Drug: CHF10067; Dose 1 CHF10067 Intravenous infusion; Drug: CHF10067; Dose 2 CHF10067 Intravenous infusion
Placebo Comparator: Treatment arm C; Placebo	Other: Placebo; Placebo Intravenous infusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Absolute change from baseline in ppFVC at Weeks 6, 12, 18, and 30	Weeks 6, 12, 18, and 30
Relative change from baseline in ppFVC at Week 24 and at Weeks 6, 12, 18, and 30	Weeks 6, 12, 18, 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%)	Weeks 6, 12, 18, 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%)	Week 24 and at Weeks 6, 12, 18
Rate of decline in ppFVC over 24 weeks	over 24 weeks
Absolute and relative change from baseline in FVC (forced vital capacity)(mL) at Week 24 and at Weeks 6, 12, 18, and 30	Week 24 and at Weeks 6, 12, 18 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)	Week 24 and at Weeks 6, 12, 18, and 30
Rate of decline in FVC (mL) over 24 weeks	over 24 Weeks
Change from baseline in the L-PF(Living with Pulmonary Fibrosis) questionnaire at Week 12 and at Week, 24	at Week12 and at Week 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	W12 and at Week 24
CHF10067 concentrations at each visit (Week 0 to Week 21)	Over 21 Weeks

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: Vincent COTTIN, Louis Pradel Hospital - Lyon, FRANCE

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): February 12, 2028
• Study Completion (Estimated): February 12, 2028

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: IPF
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: CLI-10067AA1-02; 2024-514246-37-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No