Idiopathic Pulmonary FibrosisPhase 2ZAPPHIRENCT07516951
A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis
A Phase 2 study testing CHF10067 in people with Idiopathic Pulmonary Fibrosis, run by Chiesi Farmaceutici S.p.A. at 19 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- CHF10067
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 19 sitesin 4 countries
- Study dates
- 8 Jul 2026to 27 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
19 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 4 countries
South Korea10 sites, 10 recruiting
- Recruiting
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, 14584
Sung-Woo Park
- Recruiting
Inje University Busan Paik Hospital
Busan, 47392
Hyun-Kyung Lee
- Recruiting
Inje University Haeundae Paik Hospital
Busan, 48108
Jae-Ha Lee
- Recruiting
Chonnam National University Hospital
Gwangju, 61469
Hong-Joon Shin
- Recruiting
Kyung Hee University Hospital
Seoul, 02447
Hye-sook Choi
- Recruiting
Korea University Anam Hospital
Seoul, 02841
Eun Joo Lee
- Recruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312
BoRa Lee
- Recruiting
Asan Medical Center
Seoul, 05505
Jin-Woo Song
- Recruiting
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Seoul, 07061
Deog Kyeom Kim
- Recruiting
Ajou University Hospital
Suwon, 16499
Joo Hun Park
United States6 sites, 6 recruiting
- Recruiting
Premier Pulmonary Critical Care and Sleep Medicine, PA
Denison, Texas, 75020
Sanober Kable
- Recruiting
SEC Clinical Research LLC
Dothan, Alabama, 36305
Marvin Sexton
- Recruiting
Hannibal Regional Healthcare System, Inc.
Hannibal, Missouri, 63401
Farah Humam
- Recruiting
Tennessee Comprehensive Lung and Sleep Center
Hendersonville, Tennessee, 37075
Clyde Southwell
- Recruiting
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
Michael Denenberg
- Recruiting
Pasadena Center for Medical Research, Inc
St. Petersburg, Florida, 33707
Mohamed Ali
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Papworth Hospital NHS Foundation Trust
Cambridge, CB2 0AY
Gauri Saini
- Recruiting
Royal Devon and Exeter Hospital - Royal Devon University Healthcare NHS Foundation Trust
Exeter, EX2 5DW
Pilar Rivera-Ortega
North Macedonia1 site, 1 recruiting
- Recruiting
PHI University Clinic of Pulmonology and Allergology
Skopje, 1000
Dejan V Dokic
Dejan V Dokic
About this study
Official title: A Phase IIb, Multicentre, Randomised, Double Blind, Placebo Controlled, Three-arm Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability at Week 24 of 2 Doses of CHF10067 (Zampilimab),in Participants With Idiopathic Pulmonary Fibrosis
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
- Being tested
- CHF10067, Placebo
- Keywords
- IPF
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF10067Drug
Dose 1 CHF10067 Intravenous (IV) infusion
CHF10067Drug
Dose 2 CHF10067 IV infusion
PlaceboOther
Placebo IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | CHF10067 (Test Dose 1) Receives: Drug: CHF10067 |
| Arm B | Experimental | CHF10067 (Test Dose 2) Receives: Drug: CHF10067 |
| Arm C | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure: Absolute change from baseline in ppFVC (percent predicted forced vital capacity) at Week 24.
Measured: At Week 24
Secondary outcomes (11)
Absolute change from baseline in ppFVC at Weeks 6, 12, 18, and 30
Measured: At Weeks 6, 12, 18, and 30
Relative change from baseline in ppFVC at Week 24 and at Weeks 6, 12, 18, and 30
Measured: 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%)
Measured: 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%)
Measured: At Weeks 6, 12, 18, 24 and 30
Rate of decline in ppFVC over 24 weeks
Measured: 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
Measured: 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)
Measured: At Weeks 6, 12, 18, 24 and 30
Rate of decline in FVC (mL) over 24 weeks
Measured: 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.
Measured: 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.
Measured: At Weeks 12 and 24
CHF10067 concentrations at each visit (Week 0 to Week 21)
Measured: From Week 0 up to Week 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start8 Jul 2026
- Primary completion27 Jun 2028 (estimated)
- Study completion27 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study will include a screening period of 6 weeks (including prescreening), a treatment period of 21 weeks (with evaluation of primary variable at Week 24), and a follow-up period of 9 weeks after the last dose or the discontinuation of study treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincent COTTIN, Principal investigator, Louis Pradel Hospital - Lyon, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516951
- Sponsor's protocol ID
- CLI-10067AA1-02
- Other IDs
- 2024-514246-37-00
- Acronym
- ZAPPHIRE
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Multicentre, Randomised, Double Blind, Placebo Controlled, Three-arm Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability at Week 24 of 2 Doses of CHF10067 (Zampilimab),in Participants With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT07516951
- Acronym / sponsor ID
- ZAPPHIRE / CLI-10067AA1-02
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- IPF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 27 Jun 2028 (estimated)
- Study completion
- 27 Jun 2028 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Study will include a screening period of 6 weeks (including prescreening), a treatment period of 21 weeks (with evaluation of primary variable at Week 24), and a follow-up period of 9 weeks after the last dose or the discontinuation of study treatment.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: CHF10067CHF10067 (Test Dose 1) |
| Arm B | Experimental | Drug: CHF10067CHF10067 (Test Dose 2) |
| Arm C | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHF10067Dose 1 CHF10067 Intravenous (IV) infusion | Drug | Arm A |
| CHF10067Dose 2 CHF10067 IV infusion | Drug | Arm B |
| PlaceboPlacebo IV infusion | Other | Arm C |
Primary outcome
Primary Outcome Measure: Absolute change from baseline in ppFVC (percent predicted forced vital capacity) at Week 24.
Time frame: At Week 24
11 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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.
Idiopathic Pulmonary Fibrosis (IPF)
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Active, not recruitingPhase 2
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
Active, not recruitingPhase 3
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast
Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent COTTIN principal investigator
Louis Pradel Hospital - Lyon, FRANCE
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CHF10067 in people with Idiopathic Pulmonary Fibrosis, run by Chiesi Farmaceutici S.p.A. at 19 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in South Korea, United States, United Kingdom, North Macedonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiesi Clinical Trial Info (+ 39 0521 2791, Clinicaltrials_info@chiesi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.