Idiopathic Pulmonary FibrosisPhase 2IPF-201NCT04072315
Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/
A Phase 2 study testing PLN-74809 and Knottin tracer in people with Idiopathic Pulmonary Fibrosis, run by Pliant Therapeutics, Inc. at 1 site in United States.
Trial summary
A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement. 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?
- PLN-74809 and Knottin tracer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2020to 5 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of IPF, within 5 years prior to Screening,
- FVC %predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening.
- DLco (hemoglobin-adjusted) ≥30%; historical DLco for entry in the study is permitted if within 1 month of screening.
- Participants receiving treatment for IPF with nintedanib or pirfenidone are allowed,if on a stable dose for at least 3 months
Who cannot join
- Currently receiving or planning to initiate treatment for IPF (fibrosis) with agents not approved for that indication by the FDA
- Forced expiratory volume during the first seconds of the forced breath (FEV1)/FVC ratio <0.7
- Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis that can affect FVC measurement or IPF progression
- Known acute IPF exacerbation or suspicion by the Investigator of such, within 6 months of Screening
- Smoking of any kind within 3 months of Screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Medical Center
Palo Alto, California, 94305
About this study
Official title: A Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF
A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- PLN-74809, Knottin tracer
- 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.
PLN-74809Drug
PLN-74809
Knottin tracerRadiation
Radiotracer
| Study group | Role | What they receive |
|---|---|---|
| PLN-74809 Dose Level 1 (60 mg) | Experimental | PLN-74809 Dose Level 1 (60mg) Receives: Drug: PLN-74809; Radiation: Knottin tracer |
| PLN-74809 Dose Level 2 (80 mg) | Experimental | PLN-74809 Dose Level 2 (80 mg) Receives: Drug: PLN-74809; Radiation: Knottin tracer |
| PLN-74809 Dose Level 3 (120 mg) | Experimental | PLN-74809 Dose Level 3 (120 mg) Receives: Drug: PLN-74809; Radiation: Knottin tracer |
| PLN-74809 Dose Level 4 (240 mg) | Experimental | PLN-74809 Dose Level 4 (240 mg) Receives: Drug: PLN-74809; Radiation: Knottin tracer |
| PLN-74809 Dose Level 4 (320 mg) | Experimental | PLN-74809 Dose Level 4 (320 mg) Receives: Drug: PLN-74809; Radiation: Knottin tracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug.
Assessment of the primary endpoint was made using standard methods for quantifying the amount to PET tracer bound to the αvβ6 integrin receptor in the lungs before and after administration of study drug and PK/PD modeling.
Measured: Following 1 day of dosing
Secondary outcomes (1)
Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events
Adverse events were collected from the time the participant signs the Informed Consent Form until the last day of visit (Day 14).
Measured: From screening to 1 week following the administration of PLN-74809
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start13 Feb 2020
- Primary completion27 Jun 2022
- Study completion5 Jul 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Open label, incomplete crossover, up to 2 single doses administered at two different times
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pliant Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Pliant Therapeutics Medical Monitor, Study director, Pliant Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072315
- Sponsor's protocol ID
- PLN-74809-IPF-201
- Acronym
- IPF-201
- Status last verified
- Nov 2023
- First submitted
- 23 Aug 2019
- Last updated
- 12 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mooney JJ, Jacobs S, Lefebvre EA, Cosgrove GP, Clark A, Turner SM, Decaris M, Barnes CN, Jurek M, Williams B, Duan H, Kimura R, Rizzo G, Searle G, Wardak M, Guo HH. Bexotegrast Shows Dose-Dependent Integrin alphavbeta6 Receptor Occupancy in Lungs of Participants with Idiopathic Pulmonary Fibrosis: A Phase 2, Open-Label Clinical Trial. Ann Am Thorac Soc. 2025 Mar;22(3):350-358. doi: 10.1513/AnnalsATS.202409-969OC.
PubMed 39499805
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF
- ClinicalTrials.gov ID
- NCT04072315
- Acronym / sponsor ID
- IPF-201 / PLN-74809-IPF-201
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Pliant Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 12 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Open label, incomplete crossover, up to 2 single doses administered at two different times
| Arm | Type | Receives |
|---|---|---|
| PLN-74809 Dose Level 1 (60 mg) | Experimental | Drug: PLN-74809, Radiation: Knottin tracerPLN-74809 Dose Level 1 (60mg) |
| PLN-74809 Dose Level 2 (80 mg) | Experimental | Drug: PLN-74809, Radiation: Knottin tracerPLN-74809 Dose Level 2 (80 mg) |
| PLN-74809 Dose Level 3 (120 mg) | Experimental | Drug: PLN-74809, Radiation: Knottin tracerPLN-74809 Dose Level 3 (120 mg) |
| PLN-74809 Dose Level 4 (240 mg) | Experimental | Drug: PLN-74809, Radiation: Knottin tracerPLN-74809 Dose Level 4 (240 mg) |
| PLN-74809 Dose Level 4 (320 mg) | Experimental | Drug: PLN-74809, Radiation: Knottin tracerPLN-74809 Dose Level 4 (320 mg) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of IPF, within 5 years prior to Screening,
- FVC %predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening.
- DLco (hemoglobin-adjusted) ≥30%; historical DLco for entry in the study is permitted if within 1 month of screening.
- Participants receiving treatment for IPF with nintedanib or pirfenidone are allowed,if on a stable dose for at least 3 months
Key exclusion criteria (5 listed)
- Currently receiving or planning to initiate treatment for IPF (fibrosis) with agents not approved for that indication by the FDA
- Forced expiratory volume during the first seconds of the forced breath (FEV1)/FVC ratio <0.7
- Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis that can affect FVC measurement or IPF progression
- Known acute IPF exacerbation or suspicion by the Investigator of such, within 6 months of Screening
- Smoking of any kind within 3 months of 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 |
|---|---|---|
| PLN-74809PLN-74809 | Drug | PLN-74809 Dose Level 1 (60 mg), PLN-74809 Dose Level 2 (80 mg), PLN-74809 Dose Level 3 (120 mg), PLN-74809 Dose Level 4 (240 mg), PLN-74809 Dose Level 4 (320 mg) |
| Knottin tracerRadiotracer | Radiation | PLN-74809 Dose Level 1 (60 mg), PLN-74809 Dose Level 2 (80 mg), PLN-74809 Dose Level 3 (120 mg), PLN-74809 Dose Level 4 (240 mg), PLN-74809 Dose Level 4 (320 mg) |
Primary outcome
Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug.
Time frame: Following 1 day of dosing
Assessment of the primary endpoint was made using standard methods for quantifying the amount to PET tracer bound to the αvβ6 integrin receptor in the lungs before and after administration of study drug and PK/PD modeling.
1 secondary outcome
Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events
Time frame: From screening to 1 week following the administration of PLN-74809
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39499805Mooney JJ, Jacobs S, Lefebvre EA, Cosgrove GP, Clark A, Turner SM, Decaris M, Barnes CN, Jurek M, Williams B, Duan H, Kimura R, Rizzo G, Searle G, Wardak M, Guo HH. Bexotegrast Shows Dose-Dependent Integrin alphavbeta6 Receptor Occupancy in Lungs of Participants with Idiopathic Pulmonary Fibrosis: A Phase 2, Open-Label Clinical Trial. Ann Am Thorac Soc. 2025 Mar;22(3):350-358. doi: 10.1513/AnnalsATS.202409-969OC.
- Individual participant dataSharing planned: No
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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.
Pliant Therapeutics Medical Monitor study director
Pliant Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PLN-74809 and Knottin tracer in people with Idiopathic Pulmonary Fibrosis, run by Pliant Therapeutics, Inc. at 1 site in United States.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 12 Dec 2023). 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?
Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug. (time frame: Following 1 day of dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04072315, which also lists 1 linked publication.
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 12 Dec 2023.