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

Chiesi Farmaceutici S.p.A. · NCT07516951

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 40+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
240
US sites recruiting
6
Study start
July 8, 2026
Record last updated
October 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: CHF10067; CHF10067; Placebo

Conditions: Idiopathic Pulmonary Fibrosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • SEC Clinical Research LLC

    Dothan, AL 36305

    Site contact: Marvin Sexton

  • Pasadena Center for Medical Research, Inc

    St. Petersburg, FL 33707

    Site contact: Mohamed Ali

  • Hannibal Regional Healthcare System, Inc.

    Hannibal, MO 63401

    Site contact: Farah Humam

  • Clinical Research of Rock Hill

    Rock Hill, SC 29732

    Site contact: Michael Denenberg

  • Tennessee Comprehensive Lung and Sleep Center

    Hendersonville, TN 37075

    Site contact: Clyde Southwell

  • Premier Pulmonary Critical Care and Sleep Medicine, PA

    Denison, TX 75020

    Site contact: Sanober Kable

Study contacts (from the official record)

  • Chiesi Clinical Trial Info · + 39 0521 2791 · Clinicaltrials_info@chiesi.com
A Study to Find an Efficacious and Safe Dose of CHF10067… (NCT07516951) | Bored Studies