A study to find an efficacious and safe dose of CHF10067 (zampilimab) in participants with idiopathic pulmonary fibrosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Chiesi Farmaceutici S.p.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2026-04-27

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Chiesi Farmaceutici S.p.A.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Pharmacogenomic, Pharmacokinetic, Pharmacogenetic, Efficacy, Others, Therapy, Safety

To evaluate the efficacy of 2 dose strengths of CHF10067 in terms of change from baseline in percent predicted forced vital capacity (ppFVC) at Week  24 compared to placebo in the entire study population.

Secondary objectives 2

1. 1. To evaluate the effect of CHF10067 on other lung function parameters, participant’s health status, safety, and tolerability.
2. 2. To evaluate pharmacokinetic (PK) variables after repeated doses.

Conditions and MedDRA coding

Idiopathic pulmonary fibrosis (IPF)

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Paul-Ehrlich-Institut, Food And Drug Administration, Medicines And Healthcare Products Regulatory Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1. Informed consent: Participant’s written informed consent obtained prior to any study-related procedure.
2. 2. 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.
3. 3. Body weight ≥45 kg.
4. 4. 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.
5. 5. 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.
6. 6. Diffusing capacity of the lung for carbon monoxide (DLCO) corrected for haemoglobin ≥25% of predicted normal at screening.
7. 7. Oxygen saturation measured by pulse oximetry (peripheral capillary oxygen saturation [SpO2]) >90% when the maximum oxygen flow is 4 L/min by standard nasal cannula.

Exclusion criteria 9

1. 1. Participant with a documented diagnosis of coeliac disease.
2. 2. 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;
3. 3. Lung cancer: Active diagnosis or history of lung cancer.
4. 4. Emphysema: HRCT (refer to inclusion criterion #5 [Diagnosis of IPF]), reviewed by central reading, shows the presence of emphysema ≥50% or that the extent of emphysema is greater than the extent of fibrosis.
5. 5. Organ transplantation: End-stage fibrotic disease expected to require organ transplantation within 6 months from screening.
6. 6. Other medical conditions: Clinically relevant and uncontrolled 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.
7. 7. 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.
8. 8. Hypersensitivity: Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation or any other substance used in the study.
9. 9. History of allergic or anaphylactic reaction to human, humanised, chimeric Igs, or murine monoclonal antibodies.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Week 24

Secondary endpoints 2

1. 1- Efficacy thorughout the duration of the study at Weeks 0, 6, 12, 18, 24 and 30
2. 2 - Week 0 through to Week 21

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Chiesi Farmaceutici S.p.A.

Sponsor organisation

Chiesi Farmaceutici S.p.A.

Address

Via Palermo 26 A

City

Parma

Postcode

43122

Country

Italy

Scientific contact point

Organisation

Chiesi Farmaceutici S.p.A.

Contact name

Clinical Project Manager

Public contact point

Organisation

Chiesi Farmaceutici S.p.A.

Contact name

Clinical Project Manager

Third parties 5

Locations

10 EU/EEA countries · 63 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 253 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications