RecruitingNCT07516951ZAPPHIREUpdated Sep 17, 2026

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

A Phase 2 interventional study of CHF10067 and CHF10067 in Idiopathic Pulmonary Fibrosis, sponsored by Chiesi Farmaceutici S.p.A.. Recruiting at 3 sites in 2 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Chiesi Farmaceutici S.p.A. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 240
Allocation: Randomized
Ages: 40 Years and older
Sex: All

Study 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 studied

Idiopathic Pulmonary Fibrosis

Browse trials for

Idiopathic Pulmonary Fibrosis 550

Keywords

Who can participate

Ages eligible: 40 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 240 participants (estimated)

Study arms

Experimental
Arm A
CHF10067 (Test Dose 1)
Drug: CHF10067
Experimental
Arm B
CHF10067 (Test Dose 2)
Drug: CHF10067
Placebo comparator
Arm C
Placebo
Other: Placebo

Interventions

DrugCHF10067
Dose 1 CHF10067 Intravenous (IV) infusion
DrugCHF10067
Dose 2 CHF10067 IV infusion
OtherPlacebo
Placebo IV infusion

What researchers measure

Primary outcomes

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

Secondary outcomes

Absolute change from baseline in ppFVC at Weeks 6, 12, 18, and 30
Time frame: At Weeks 6, 12, 18, and 30
Relative change from baseline in ppFVC at Week 24 and at Weeks 6, 12, 18, and 30
Time frame: 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%)
Time frame: 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%)
Time frame: At Weeks 6, 12, 18, 24 and 30
Rate of decline in ppFVC over 24 weeks
Time frame: Up to 24 weeks
Absolute and relative change from baseline in FVC (forced vital capacity) milliliter (mL) at Week 24 and at Weeks 6, 12, 18, and 30
Time frame: At Weeks 6, 12, 18, 24 and 30
Categorical absolute change from baseline in FVC (mL) at Week 24 and at Weeks 6, 12, 18, and 30 (5 dichotomous thresholds: -200 mL, -100 mL, 0 mL, 100 mL, and 200 mL)
Time frame: At Weeks 6, 12, 18, 24 and 30
Rate of decline in FVC (mL) over 24 weeks
Time frame: Up to 24 Weeks
Change from baseline in the Living with Pulmonary Fibrosis (L-PF) questionnaire at Week 12 and at Week 24
L PF is a patient-reported questionnaire designed to assess health-related quality of life in participants with progressive fibrosing interstitial lung disease (ILD). The questionnaire comprises two distinct modules: L PF symptoms (23 items) and L PF impacts (21 items). The symptoms module assesses shortness of breath, cough, and fatigue over the past 24 hours. The impacts module assesses multiple aspects of health-related quality of life with a recall period of one week. Scores range from 0 to 100, with higher scores indicating worse symptoms and poorer quality of life. A negative change from baseline indicated better symptoms and better quality of life.
Time frame: At Weeks 12 and 24
Change from baseline in specific modules of the L-PF questionnaire (symptoms and impact) and within the symptom modules of specific domains (shortness of breath, cough, and fatigue) at Week 12 and at Week 24
L PF is a patient-reported questionnaire designed to assess health-related quality of life in participants with progressive fibrosing ILD. The questionnaire comprises two distinct modules: L PF symptoms (23 items) and L PF impacts (21 items). The symptoms module assesses shortness of breath, cough, and fatigue over the past 24 hours. The Impacts module assesses multiple aspects of health-related quality of life with a recall period of one week. Scores range from 0 to 100, with higher scores indicating worse symptoms and poorer quality of life. A negative change from baseline indicated better symptoms and quality of life.
Time frame: At Weeks 12 and 24
CHF10067 concentrations at each visit (Week 0 to Week 21)
Time frame: From Week 0 up to Week 21

Study locations

3 of 3 sites recruiting

Hannibal Regional Healthcare System, Inc.
Hannibal, Missouri 63401, United States
- Farah Humam · Contact
Recruiting
Premier Pulmonary Critical Care and Sleep Medicine, PA
Denison, Texas 75020, United States
- Sanober Kable · Contact
Recruiting
PHI University Clinic of Pulmonology and Allergology
Skopje, 1000, North Macedonia
- Dejan V Dokic · Contact
- Dejan V Dokic · Principal investigator
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT07516951
Lead sponsor: Chiesi Farmaceutici S.p.A.
Responsible party: Sponsor
First posted: Apr 8, 2026
Start date: Jul 8, 2026
Primary completion: Jun 27, 2028 (estimated)
Completion: Jun 27, 2028 (estimated)
Last update: Sep 17, 2026

Study contacts

Chiesi Clinical Trial Info

Contact

Clinicaltrials_info@chiesi.com

+ 39 0521 2791

Vincent COTTIN

principal investigator · Louis Pradel Hospital - Lyon, FRANCE

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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