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

NCT07516951 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: CLI-10067AA1-022024-514246-37-00
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

IPF

Outcome Measures

Primary Outcomes (1)

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

  At Week 24

Secondary Outcomes (11)

• 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

Study Arms (3)

Arm A

EXPERIMENTAL

CHF10067 (Test Dose 1)

Drug: CHF10067

Arm B

EXPERIMENTAL

CHF10067 (Test Dose 2)

Drug: CHF10067

Arm C

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

CHF10067 DRUG

Dose 1 CHF10067 Intravenous (IV) infusion

Arm A

Placebo OTHER

Placebo IV infusion

Arm C

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

PHI University Clinic of Pulmonology and Allergology

Skopje, 1000, North Macedonia

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Vincent COTTIN

  Louis Pradel Hospital - Lyon, FRANCE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiesi Clinical Trial Info

CONTACT

+ 39 0521 2791; Clinicaltrials_info@chiesi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): February 12, 2028
• Study Completion (Estimated): February 12, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)