What is CHF10067 studying for idiopathic pulmonary fibrosis?

CHF10067 is being studied to evaluate its effectiveness, safety, and tolerability in adults with idiopathic pulmonary fibrosis (IPF). The trial aims to compare two doses of CHF10067 with a placebo to understand their impact on lung function over 24 weeks. This research is sponsored by Chiesi Farmaceutici S.p.A.

Who may be eligible for this idiopathic pulmonary fibrosis clinical trial?

Adults aged 40 years or older with a diagnosis of idiopathic pulmonary fibrosis made within the past 8 years may be eligible. Participants must weigh at least 45 kg and have specific lung function measurements. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this idiopathic pulmonary fibrosis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 40Years +

All Genders

ID07516951

Phase IIb Study Evaluating Safety and Effectiveness of Two Doses of CHF10067 Zampilimab Infusions for Adults with Idiopathic Pulmonary Fibrosis

Led by Chiesi Farmaceutici S.p.A. · Updated on 2026-07-16

240

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating two different doses of CHF10067 zampilimab to assess their effectiveness, safety, and tolerability in adults with idiopathic pulmonary fibrosis IPF. This phase IIb, multicenter, randomized, double-blind, placebo-controlled study involves 240 participants across about 150 sites worldwide. The study focuses on changes in lung function, specifically percent predicted forced vital capacity ppFVC, at Week 24. Participants will be randomly assigned to one of three groups receiving either one of two doses of CHF10067 or a placebo, all administered via intravenous infusion. The study treatment is given over a 24-week period, with evaluations at several points including Weeks 6, 12, 18, 24, and 30. This design allows comparison of the drug doses against placebo while monitoring drug levels and effects over time. During the study, participants will undergo lung function tests, oxygen saturation measurements, and complete questionnaires related to living with pulmonary fibrosis. Blood samples will be taken to measure drug concentration. Various outcome measures such as absolute and relative changes in lung function and symptom assessments will be collected up to Week 30. Safety and tolerability will be closely monitored throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participant provides written informed consent before any study procedures
Male or female aged 40 years or older with at least 1 year life expectancy
Body weight of 45 kg or more
Diagnosis of idiopathic pulmonary fibrosis within 8 years confirmed by recent HRCT
Forced vital capacity (FVC) at least 45% of predicted normal value
Forced expiratory volume in 1 second (FEV1)/FVC ratio of 0.7 or higher
Diffusing capacity of the lung for carbon monoxide (DLCO) corrected for hemoglobin 25% or higher of predicted normal
Oxygen saturation (SpO2) greater than 90% at rest with oxygen flow up to 4 L/min by nasal cannula or equivalent

You will not qualify if you...

Diagnosis of coeliac disease
Lower respiratory tract infection or acute exacerbation of IPF within 4 weeks before screening
Active or history of lung cancer
Emphysema covering 20% or more of lungs or greater extent than fibrosis on HRCT
Expected need for organ transplantation within 6 months of screening
Clinically relevant uncontrolled pulmonary, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders
Active or untreated latent tuberculosis infection
Any other non-IPF pulmonary condition affecting lung function except allowed emphysema
Treatment with cytotoxic or immunosuppressant drugs in past 48 weeks
Systemic corticosteroids equivalent to prednisone over 10 mg/day for more than 10 days
Known intolerance or hypersensitivity to study drug components or monoclonal antibodies

Research Team

Chiesi Clinical Trial Info

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