Idiopathic Pulmonary FibrosisPhase 2NCT05497284
To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF
A Phase 2 study testing LTP001 in people with Idiopathic Pulmonary Fibrosis, run by Novartis Pharmaceuticals at 15 sites in 7 countries.
Trial summary
A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- LTP001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 15 sitesin 7 countries
- Study dates
- 10 Nov 2022to 26 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants at least 40 years of age
- IPF diagnosed based on ATS/ERS/JRS/ALAT IPF 2018 modified guidelines
- FVC ≥45% predicted
- DLCO, corrected for hemoglobin, ≥25% predicted (inclusive)
- Unlikely to undergo lung transplantation during this trial in the opinion of the investigator
- If a participant is taking nintedanib or pirfenidone, they must be on a stable regimen for at least 8 weeks prior to randomization
Who cannot join
- Airway obstruction (i.e. prebronchodilator FEV1/ FVC < 0.7) or evidence of a bronchodilator response at screening
- Emphysema >20% on screening HRCT
- Fibrosis <10% on screening HRCT
- Clinical diagnosis of any connective tissue disease
- Clinically diagnosed acute exacerbation of IPF (AE-IPF) or other significant clinical worsening within 3 months of randomization
- Additional protocol-defined inclusion / exclusion criteria may apply.
Trial locations and contacts
15 sites in 7 countries.
15 sites in 7 countries
Argentina3 sites
Novartis Investigative Site
CABA, Buenos Aires, C1056ABJ
Novartis Investigative Site
Paraná, 3100
Novartis Investigative Site
Ranelagh Partido de Berazate, Buenos Aires, 1884
Australia3 sites
Novartis Investigative Site
Camperdown, New South Wales, 2050
Novartis Investigative Site
Chermside, Queensland, 4032
Novartis Investigative Site
Spearwood, Western Australia, 6163
Germany3 sites
Novartis Investigative Site
Coswig, 01640
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Munich, Bavaria, 81377
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Kansas Hospital
Kansas City, Kansas, 66160
Netherlands2 sites
Novartis Investigative Site
Amsterdam, North Holland, 1081 HV
Novartis Investigative Site
Nieuwegein, Utrecht, 3435 CM
About this study
Official title: A Participant- and Investigator-blinded, Randomized, Placebo-controlled, Multicenter, Platform Study to Investigate Efficacy, Safety, and Tolerability of Various Single Treatments in Participants With Idiopathic Pulmonary Fibrosis
A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis
Read the detailed description
This was a randomized, placebo-controlled, participant- and investigator-blinded platform study in participants with idiopathic pulmonary fibrosis. Participants underwent a screening period of 42 days, a treatment period of 26 weeks and a post-treatment safety follow-up period of 30 days. This study was designed to safely allow rapid and efficient screening of potentially efficacious investigational products in participants with IPF. The study was terminated for strategic reasons and no additional cohorts were created.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- LTP001, Placebo, Standard of Care (SoC)
- Keywords
- Idiopathic pulmonary fibrosis, FVC, DLCO, 6-minute walk test, patient reported outcome, HRCT
- 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.
LTP001Drug
LTP001 administered once daily in the morning
PlaceboDrug
Placebo to LTP001 administered once daily in the morning
Standard of Care (SoC)Drug
nintedanib, pirfenidone, or neither
| Study group | Role | What they receive |
|---|---|---|
| LTP001 | Experimental | LTP001 orally once daily in the morning for approximately 26 weeks. Receives: Drug: LTP001; Drug: Standard of Care (SoC) |
| Placebo | Experimental | Placebo orally once daily in the morning for approximately 26 weeks. Receives: Drug: Placebo; Drug: Standard of Care (SoC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to End of Treatment Epoch in Forced Vital Capacity (FVC) Expressed in Percent Predicted
Forced Vital Capacity (FVC) is the total amount of air exhaled during the Forced expiratory volume (FEV) test measured through spirometry testing. FEV measures how much air a person can exhale during a forced breath. It is expressed as percent predicted, defined as FVC of the participant divided by the average FVC in the population for any person of similar age, sex, and body composition multiplied by 100. A positive change from baseline is considered a favorable outcome.
Measured: Baseline, up to approximately 26 weeks
Secondary outcomes (9)
Change From Baseline to End of Treatment Epoch in FVC
Forced Vital Capacity (FVC) is the total amount of air exhaled during the Forced expiratory volume (FEV) test measured through spirometry testing. FEV measures how much air a person can exhale during a forced breath. A positive change from baseline is considered a favorable outcome.
Measured: Baseline, up to approximately 26 weeks
Progression-free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of the any of the following events: Absolute reduction from baseline of ≥10% predicted in FVC, Nonelective hospitalization for respiratory events, Lung Transplant, Death. PFS was analyzed based on Kaplan-Meier estimates.
Measured: Baseline, up to approximately 26 weeks
Number of Participants With Absolute Decline of ≥10% Predicted in FVC
Binary output of absolute decline of ≥ 10% predicted in FVC (Yes/No) at the end of treatment epoch.
Measured: Baseline, up to approximately 26 weeks
Change From Baseline to the End of Treatment Epoch in Diffusion Capacity of Lung for Carbon Monoxide (DLCO)
Diffusing capacity of the lungs for carbon monoxide (DLCO) is a measurement to assess the ability of the lungs to transfer gas from inspired air to the bloodstream. Inhaled carbon monoxide (CO) is used for this test due to its high affinity for hemoglobin. During a ten-second breath-hold, DLCO measures uptake of CO per time per CO pressure.
Measured: Baseline, up to approximately 26 weeks
Change From Baseline to the End of Treatment Epoch in 6-minute Walk Distance (6MWD)
The 6MWD test is self-paced, with standardized instructions and encouragement being given as participants walk as far as possible over 6 minutes through a flat corridor. The final distance is recorded in meters. A positive change from baseline in 6MWD is considered a favourable outcome.
Measured: Baseline, up to approximately 26 weeks
Change From Baseline to the End of Treatment Epoch in Total Score From the K-BILD Questionnaire
The King's Brief Interstitial Lung Disease (K-BILD) is a 15-item HRQOL questionnaire that range from 0 to 100. Higher scores indicate better health-related quality of life, with 100 representing the best possible health status. A positive change from baseline in K-BILD questionnaire is considered a favourable outcome.
Measured: Baseline, up to approximately 26 weeks
Change From Baseline to the End of Treatment Epoch in Scores From Leicester Cough Questionnaire
The Leicester Cough Questionnaire (LCQ) is a 19-item validated patient-report questionnaire that measures the impact of cough on quality of life. It takes about 5 minutes to complete and results in three domain scores (Social, Psychological, and Physical), and one Total score. Domain scores are averages of the questions that make up each domain. Minimum and maximum domain scores are 1 and 7, respectively. The domain scores are summed to determine the Total score, which can range from 3 to 21. A higher score means less impact on quality of life. A positive LCQ change score indicates an improvement.
Measured: Baseline, up to approximately 26 weeks
Change From Baseline to the End of Treatment Epoch in Scores From the the R-Scale for IPF Questionnaire
The Raghu-Scale for Pulmonary Fibrosis (R-Scale for PF) is a questionnaire designed to assess the impact of lung disease on quality of life. The R-Scale-PF uses a numerical rating scale to assess the severity of five symptoms: cough, shortness of breath, fatigue, depressed mood, and overall sense of wellbeing, over the past two weeks. Each item is scored from 0 to 10, with lower scores indicating better health-related quality of life. The total R-Scale-PF score ranges from 0 to 50. A decrease from baseline in R-Scale for PF is considered a favourable outcome.
Measured: Baseline, up to approximately 26 weeks
Change From Baseline to the End of Treatment Epoch in Total Score From the Living With IPF Questionnaire
Living with idiopathic pulmonary fibrosis (L-IPF) is a tool that assesses symptoms and impacts of IPF. The Symptoms Module consists of 20 questions to assess symptoms experienced from IPF over the last 24 hours. The Impacts Module consists of 20 questions on how IPF affects quality of life over the last 7 days. The total score ranging from 0 to 100, with higher scores indicating greater symptom severity. A positive change from baseline in L-IPF is considered a favourable outcome.
Measured: Baseline, up to approximately 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start10 Nov 2022
- Primary completion26 Aug 2024
- Study completion26 Sep 2024
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497284
- Sponsor's protocol ID
- CADPT09A12201
- Status last verified
- Dec 2025
- First submitted
- 5 Aug 2022
- Last updated
- 13 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Participant- and Investigator-blinded, Randomized, Placebo-controlled, Multicenter, Platform Study to Investigate Efficacy, Safety, and Tolerability of Various Single Treatments in Participants With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT05497284
- Acronym / sponsor ID
- CADPT09A12201
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic pulmonary fibrosis, FVC, DLCO, 6-minute walk test, patient reported outcome, HRCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Posted 18 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis
Detailed description
This was a randomized, placebo-controlled, participant- and investigator-blinded platform study in participants with idiopathic pulmonary fibrosis. Participants underwent a screening period of 42 days, a treatment period of 26 weeks and a post-treatment safety follow-up period of 30 days. This study was designed to safely allow rapid and efficient screening of potentially efficacious investigational products in participants with IPF. The study was terminated for strategic reasons and no additional cohorts were created.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LTP001 | Experimental | Drug: LTP001, Drug: Standard of Care (SoC)LTP001 orally once daily in the morning for approximately 26 weeks. |
| Placebo | Experimental | Drug: Placebo, Drug: Standard of Care (SoC)Placebo orally once daily in the morning for approximately 26 weeks. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female participants at least 40 years of age
- IPF diagnosed based on ATS/ERS/JRS/ALAT IPF 2018 modified guidelines
- FVC ≥45% predicted
- DLCO, corrected for hemoglobin, ≥25% predicted (inclusive)
- Unlikely to undergo lung transplantation during this trial in the opinion of the investigator
Key exclusion criteria (6 listed)
- Airway obstruction (i.e. prebronchodilator FEV1/ FVC < 0.7) or evidence of a bronchodilator response at screening
- Emphysema >20% on screening HRCT
- Fibrosis <10% on screening HRCT
- Clinical diagnosis of any connective tissue disease
- Clinically diagnosed acute exacerbation of IPF (AE-IPF) or other significant clinical worsening within 3 months of randomization
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 |
|---|---|---|
| LTP001LTP001 administered once daily in the morning | Drug | LTP001 |
| PlaceboPlacebo to LTP001 administered once daily in the morning | Drug | Placebo |
| Standard of Care (SoC)nintedanib, pirfenidone, or neither | Drug | LTP001, Placebo |
Primary outcome
Change From Baseline to End of Treatment Epoch in Forced Vital Capacity (FVC) Expressed in Percent Predicted
Time frame: Baseline, up to approximately 26 weeks
Forced Vital Capacity (FVC) is the total amount of air exhaled during the Forced expiratory volume (FEV) test measured through spirometry testing. FEV measures how much air a person can exhale during a forced breath. It is expressed as percent predicted, defined as FVC of the participant divided by the average FVC in the population for any person of similar age, sex, and body composition multiplied by 100. A positive change from baseline is considered a favorable outcome.
9 secondary outcomes
Change From Baseline to End of Treatment Epoch in FVC
Time frame: Baseline, up to approximately 26 weeks
Progression-free Survival (PFS)
Time frame: Baseline, up to approximately 26 weeks
Number of Participants With Absolute Decline of ≥10% Predicted in FVC
Time frame: Baseline, up to approximately 26 weeks
Change From Baseline to the End of Treatment Epoch in Diffusion Capacity of Lung for Carbon Monoxide (DLCO)
Time frame: Baseline, up to approximately 26 weeks
Change From Baseline to the End of Treatment Epoch in 6-minute Walk Distance (6MWD)
Time frame: Baseline, up to approximately 26 weeks
Change From Baseline to the End of Treatment Epoch in Total Score From the K-BILD Questionnaire
Time frame: Baseline, up to approximately 26 weeks
Change From Baseline to the End of Treatment Epoch in Scores From Leicester Cough Questionnaire
Time frame: Baseline, up to approximately 26 weeks
Change From Baseline to the End of Treatment Epoch in Scores From the the R-Scale for IPF Questionnaire
Time frame: Baseline, up to approximately 26 weeks
Change From Baseline to the End of Treatment Epoch in Total Score From the Living With IPF Questionnaire
Time frame: Baseline, up to approximately 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 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 LTP001 in people with Idiopathic Pulmonary Fibrosis, run by Novartis Pharmaceuticals at 15 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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Argentina, Australia, Germany, United States, Netherlands 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. 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?
Yes. Results are posted in the registry (first posted 18 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to End of Treatment Epoch in Forced Vital Capacity (FVC) Expressed in Percent Predicted (time frame: Baseline, up to approximately 26 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 13 Jan 2026.