Recruiting
Phase 2

CHF10067

Sponsor:

Chiesi Farmaceutici S.p.A.

Code:

NCT07516951

Conditions

Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

CHF10067

CHF10067

Placebo

Study Details

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

Study ID

NCT07516951

Start date

Jul 8, 2026

Status verified date

Sep, 2026

Completion date

Jun 27, 2028

Anticipated

Primary completion date

Jun 27, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

CHF10067 (Test Dose 1)

experimental: Arm B

CHF10067 (Test Dose 2)

placebo comparator: Arm C

Placebo

Interventions

CHF10067

Dose 1 CHF10067 Intravenous (IV) infusion

CHF10067

Dose 2 CHF10067 IV infusion

Placebo

Placebo IV infusion

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Chiesi Clinical Trial Info

+ 39 0521 2791Clinicaltrials_info@chiesi.com

Locations

Hannibal Regional Healthcare System, Inc.

Recruiting

Hannibal, Missouri, United States, 63401

Premier Pulmonary Critical Care and Sleep Medicine, PA

Recruiting

Denison, Texas, United States, 75020

More Information

Sponsor

Chiesi Farmaceutici S.p.A.

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Keywords

  • IPF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Chiesi Farmaceutici S.p.A. on 2026-09-17.