Idiopathic Pulmonary Fibrosis (IPF)Phase 2AURA-IPFNCT07194382
AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF
A Phase 2 study testing AP02 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Avalyn Pharma Inc. at 49 sites in 7 countries.
Trial summary
This study will evaluate the impact Nintedanib Solution for Inhalation (AP02) has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF) as well as assess its safety and tolerability. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- AP02
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 49 sitesin 7 countries
- Study dates
- 10 Mar 2026to Jun 2027
- 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
- Male or female patients aged ≥40 years at the time of signing the written informed consent form
- Diagnosis of idiopathic pulmonary fibrosis (IPF) as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/ Asociación Latinoamericana de Tórax IPF guidelines within 5 years
- Combination of High-Resolution Computerized Tomography (HRCT) pattern, and if available, surgical lung biopsy pattern consistent with diagnosis of IPF
- In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation
- Forced vital capacity (FVC) ≥45% predicted of normal
- Lung diffusion test (DLCO) corrected for hemoglobin (Hgb) ≥30% and ≤80% predicted of normal.
- Women and men of childbearing potential must use highly effective contraception measures until 90 days after the last dose of study drug.
Who cannot join
- Current treatment with oral nintedanib, oral pirfenidone, or previous treatment with oral nintedanib or oral pirfenidone within 3 months prior to screening. Participants who have taken both oral nintedanib and pirfenidone together as a treatment will not be able to join the study.
- Forced expiratory volume (FEV) in the first second/FVC (FEV1/FVC) ratio ≥0.7 based on pre-bronchodilator value
- Participants with a history of serious cardiovascular disease, bleeding problems or significant liver or kidney disease (as defined in the study protocol)
- History of diverticular disease or abdominal surgery within 4 weeks prior to screening visit
- History of cancer within the past 5 years (except for certain types explained in the protocol)
- Participants who have smoked within the past 3 months prior to screening, who are not willing to stop smoking during the study, or who currently use illegal drugs or drugs of abuse
Show all 9Show fewer
- Female participants who are pregnant or nursing
- Use of any investigational drugs including those for IPF within the past 30 days prior to screening
- Further inclusion/exclusion criteria apply
Trial locations and contacts
49 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
49 sites in 7 countries
United Kingdom13 sites, 13 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands
- Recruiting
University Hospitals Birmingham NHS Foundation Trust - Heartlands Hospital
Birmingham
- Recruiting
Royal Papworth Hospital NHS Foundation Trust
Cambridge
- Recruiting
Hull University Hospitals NHS Trust
Cottingham, East Riding of Yorkshire
- Recruiting
Royal Devon University Hospital
Exeter, Devon
- Recruiting
Leicester Biomedical Research Centre
Leicester, Leicestershire
- Recruiting
Aintree University Hospital
Liverpool
- Recruiting
Royal Brompton Hospital, Guy's and St Thomas NHS Foundation Trust
London
- Recruiting
St. George's University Hospitals NHS Foundation Trust
London
- Recruiting
Altnagelvin Hospital Campus
Londonderry
- Recruiting
Manchester University NHS Foundation Trust - NIHR Manchester Clinical Research Facility at Wythenshawe Hospital
Manchester
- Recruiting
Oxford University Hospitals NHS Foundation Trust - Churchill Hospital
Oxford
- Recruiting
NHS Tayside - Perth Royal Infirmiry (Scotland)
Perth
Canada10 sites, 10 recruiting
- Recruiting
Dynamic Drug Advancement
Ajax, Ontario, L1S2J5
- Recruiting
University of Calgary - Foothills Medical Centre
Calgary, Alberta
- Recruiting
Queen Elizabeth
Halifax, Nova Scotia
- Recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec
- Recruiting
Jewish General Hospital
Montreal, Quebec
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hôpital Fleurimont
Sherbrooke, Quebec
- Recruiting
Newfoundland and Labrador Health Services
St. John's, Newfoundland and Labrador
- Recruiting
University Health Network - Toronto General Hospital
Toronto, Ontario
- Recruiting
CIC Mauricie
Trois-Rivières, Quebec, G8T 7A1
- Recruiting
Centre for Lung Health - Vancouver General Hospital
Vancouver, British Columbia
Spain9 sites, 9 recruiting
- Recruiting
Hospital Germans Trias i Pujol/Hospital Can Ruti
Badalona, Barcelona
- Recruiting
Hospital Clínic de Barcelona
Barcelona
- Recruiting
Hospital General de Granollers, Barcelona
Granollers, Barcelona
- Recruiting
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Catalonia / Barcelona
- Recruiting
Hospital HM Sanchinarro
Madrid
- Recruiting
Hospital Universitario de la Princesa
Madrid
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga
- Recruiting
Consorci Corporació Sanitària Parc Taulí (Parc Taulí Hospital Universitari)
Sabadell, Catalonia / Barcelona
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria
Australia8 sites, 8 recruiting
- Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales
- Recruiting
Austin Health
Heidelberg, Victoria
- Recruiting
Nepean Lung and Sleep
Kingswood, New South Wales, 2747
- Recruiting
Launceston Respiratory and Sleep Centre
Launceston, Tasmania
- Recruiting
The Alfred Hospital
Melbourne, Victoria
- Recruiting
John Hunter Hospital
New Lambton Heights, New South Wales
- Recruiting
Macquarie University Hospital
Sydney, New South Wales
- Recruiting
Ludwig Engel Centre for Respiratory Research
Westmead, New South Wales, 2145
Germany4 sites, 4 recruiting
- Recruiting
Studienzentrum Dr. Keller
Frankfurt am Main, Hesse
- Recruiting
Universitätsklinikum Heidelberg - Thoraxklinik Heidelberg
Heidelberg
- Recruiting
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz
- Recruiting
Pneumologisches Studienzentrum München-West
Munich, Bavaria
New Zealand3 sites, 3 recruiting
- Recruiting
Greenlane Clinical Centre
Auckland
- Recruiting
Christchurch Hospital
Christchurch, Cantebury
- Recruiting
Waikato Hospital
Hamilton, Waikato Region
Sandra Hopping
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Istanbul University Cerrahpasa Hospital
Istanbul
- Recruiting
Gülhane Saglik Bilimleri Fakültesi
Keçiören
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Proof of Concept (POC) Study Evaluating the Safety, Tolerability, and Efficacy of Nintedanib Solution for Inhalation (AP02) in Participants With Idiopathic Pulmonary Fibrosis (IPF) (AURA-IPF)
This study will evaluate the impact Nintedanib Solution for Inhalation (AP02) has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF) as well as assess its safety and tolerability.
Adults 40 years of age or older with IPF who meet the inclusion and exclusion criteria can participate in this study if they are not currently on treatment for IPF, and if treated with oral nintedanib or pirfenidone, have stopped the medication for at least 3 months.
Read more
Researchers will compare two different doses of AP02 to a placebo (a look-alike substance that contains no drug) to see if AP02 works to treat IPF. Participants are put into 1 of 3 groups randomly, which means by chance and will take AP02 or a placebo two times every day for 12 weeks by using a nebulizer, which is a device that provides medicine to the lungs via inhalation.
Participants will visit the office 6 times and receive 1 phone call over a 16-week period. At site visits doctors regularly perform breathing tests that measure how well the lungs are working, give the patient questionnaires and will check the participants' health.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- AP02, Placebo
- Keywords
- Idiopathic Pulmonary Fibrosis, IPF, AP02
- 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.
AP02Drug
Oral inhalation solution
PlaceboDrug
Placebo oral inhalation solution
| Study group | Role | What they receive |
|---|---|---|
| Placebo BID | Placebo comparator | Placebo solution for Inhalation Receives: Drug: Placebo |
| AP02 low dose BID | Active comparator | Nintedanib solution for Inhalation Receives: Drug: AP02 |
| AP02 high dose BID | Active comparator | Nintedanib solution for Inhalation Receives: Drug: AP02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the morning pre-dose forced vital capacity at Week 12
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (2)
Time to disease progression
Disease progression is defined as forced vital capacity (FVC) percent predicted decline of ≥10% prior to Week 12, respiratory hospitalization, or death.
Measured: From enrollment to the end of treatment at 12 weeks
To evaluate the change from baseline in quantitative lung fibrosis score
Change in lung fibrosis score.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start10 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avalyn Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194382
- Sponsor's protocol ID
- AP02-003
- Acronym
- AURA-IPF
- Status last verified
- Feb 2026
- First submitted
- 4 Sep 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Proof of Concept (POC) Study Evaluating the Safety, Tolerability, and Efficacy of Nintedanib Solution for Inhalation (AP02) in Participants With Idiopathic Pulmonary Fibrosis (IPF) (AURA-IPF)
- ClinicalTrials.gov ID
- NCT07194382
- Acronym / sponsor ID
- AURA-IPF / AP02-003
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- Idiopathic Pulmonary Fibrosis, IPF, AP02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Avalyn Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Sep 2025 (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.
This study will evaluate the impact Nintedanib Solution for Inhalation (AP02) has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF) as well as assess its safety and tolerability.
Adults 40 years of age or older with IPF who meet the inclusion and exclusion criteria can participate in this study if they are not currently on treatment for IPF, and if treated with oral nintedanib or pirfenidone, have stopped the medication for at least 3 months.
Researchers will compare two different doses of AP02 to a placebo (a look-alike substance that contains no drug) to see if AP02 works to treat IPF. Participants are put into 1 of 3 groups randomly, which means by chance and will take AP02 or a placebo two times every day for 12 weeks by using a nebulizer, which is a device that provides medicine to the lungs via inhalation.
Participants will visit the office 6 times and receive 1 phone call over a 16-week period. At site visits doctors regularly perform breathing tests that measure how well the lungs are working, give the patient questionnaires and will check the participants' health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo BID | Placebo comparator | Drug: PlaceboPlacebo solution for Inhalation |
| AP02 low dose BID | Active comparator | Drug: AP02Nintedanib solution for Inhalation |
| AP02 high dose BID | Active comparator | Drug: AP02Nintedanib solution for Inhalation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients aged ≥40 years at the time of signing the written informed consent form
- Diagnosis of idiopathic pulmonary fibrosis (IPF) as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/ Asociación Latinoamericana de Tórax IPF guidelines within 5 years
- Combination of High-Resolution Computerized Tomography (HRCT) pattern, and if available, surgical lung biopsy pattern consistent with diagnosis of IPF
- In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation
- Forced vital capacity (FVC) ≥45% predicted of normal
Key exclusion criteria (9 listed)
- Current treatment with oral nintedanib, oral pirfenidone, or previous treatment with oral nintedanib or oral pirfenidone within 3 months prior to screening. Participants who have taken both oral nintedanib and pirfenidone together as a treatment will not be able to join the study.
- Forced expiratory volume (FEV) in the first second/FVC (FEV1/FVC) ratio ≥0.7 based on pre-bronchodilator value
- Participants with a history of serious cardiovascular disease, bleeding problems or significant liver or kidney disease (as defined in the study protocol)
- History of diverticular disease or abdominal surgery within 4 weeks prior to screening visit
- History of cancer within the past 5 years (except for certain types explained in the protocol)
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 |
|---|---|---|
| AP02Oral inhalation solution | Drug | AP02 high dose BID, AP02 low dose BID |
| PlaceboPlacebo oral inhalation solution | Drug | Placebo BID |
Primary outcome
Change from baseline in the morning pre-dose forced vital capacity at Week 12
Time frame: From enrollment to the end of treatment at 12 weeks
2 secondary outcomes
Time to disease progression
Time frame: From enrollment to the end of treatment at 12 weeks
To evaluate the change from baseline in quantitative lung fibrosis score
Time frame: From enrollment to the end of treatment at 12 weeks
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 15 Oct 2026.
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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.
49 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AP02 in people with Idiopathic Pulmonary Fibrosis (IPF), run by Avalyn Pharma Inc. at 49 sites in 7 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 9 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 15 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 49 sites in United Kingdom, Canada, Spain, Australia, Germany and 2 more countries. 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 Craig S Conoscenti, MD, FCCP, ATSF (206-707-0340, AP02-003regulatory@avalynpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the morning pre-dose forced vital capacity at Week 12 (time frame: From enrollment to the end of treatment at 12 weeks). 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 15 Oct 2026.