Idiopathic Pulmonary FibrosisPhase 2PLN-74809NCT05621252
Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809)
A Phase 2 study testing PLN-74809 in people with Idiopathic Pulmonary Fibrosis, run by Pliant Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 2a, single -center, randomized, double-blind, placebo-controlled study to evaluate type 1 collagen deposition in the lungs following once-daily treatment with PLN-74809 for 12-weeks. This study is occurring at Massachusetts General Hospital. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2022to 8 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants, aged 40 years or older
- Diagnosis of IPF, within 8 years prior to Screening
- FVC % predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening
- Diffusing capacity for carbon monoxide DLco (hemoglobin-adjusted) ≥30%; historical DLco for entry in the study is permitted if within 1 month of Screening
- Participants currently receiving treatment for IPF with nintedanib or pirfenidone are permitted, 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 at Screening
- 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
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Evaluation of PLN-74809 on Type 1 Collagen Deposition Using 68Ga-CBP8 PET/MRI Imaging in Participants With Idiopathic Pulmonary Fibrosis (IPF)
This is a Phase 2a, single -center, randomized, double-blind, placebo-controlled study to evaluate type 1 collagen deposition in the lungs following once-daily treatment with PLN-74809 for 12-weeks. This study is occurring at Massachusetts General Hospital.
Read the detailed description
This is a Phase 2a, single-center, randomized, double-blinded, placebo-controlled study to evaluate type 1 collagen deposition in the lungs of participants with Idiopathic Pulmonary Fibrosis (IPF) following once-daily (QD) treatment with 160 mg PLN-74809 for 12 weeks. The study consists of an up to 28-day screening period, a 12-week treatment period, and a 2 week (±3 days) post treatment follow-up period.
Approximately 12 eligible participants will be randomized in a 2:1 ratio (160 mg PLN-74809 vs placebo; approximately 8 receiving PLN-74809 and 4 receiving placebo) on Day 1 (Visit 3). Randomization will be stratified by use of standard of care IPF therapy with pirfenidone or nintedanib. PET/MRI scans will be conducted at Baseline and at Week 12.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- PLN-74809, Placebo
- 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
160 mg PLN-74809
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| PLN-74809 | Experimental | 160 mg PLN-74809 Receives: Drug: PLN-74809 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Change from Baseline in top quartile whole lung PET standardized uptake value (SUV) following 12 weeks of treatment with PLN-74809. The whole lung SUV measures the intensity of the uptake of the radiotracer, 68GA-CBP8: peptide-based collagen binding probe 8 tagged with Gallium-68 radioisotope, in lung tissue. A negative change from baseline is a positive outcome and represents a decrease in the whole lung SUV corresponding to a decrease in collagen deposition in the lung. A positive change from baseline is a negative outcome and represents an increase in the whole lung SUV corresponding to an increase in collagen deposition in the lung.
Measured: 12 weeks
Secondary outcomes (1)
Secondary Safety and Tolerability
Safety and tolerability of PLN-74809 as measured by the incidence of adverse events.
Measured: From screening period (up to 28 days) to treatment period of 12 weeks, to 2 weeks after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start13 Jul 2022
- Primary completion27 Dec 2023
- Study completion8 Jan 2024
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1 randomization PLN-74809:placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pliant Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sydney Montesi, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621252
- Sponsor's protocol ID
- PLN-74809-IPF-205
- Acronym
- PLN-74809
- Status last verified
- Nov 2025
- First submitted
- 2 Nov 2022
- Last updated
- 5 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Montesi SB, Cosgrove GP, Turner SM, Zhou IY, Efthimiou N, Susnjar A, Catana C, Fromson C, Clark A, Decaris M, Barnes CN, Lefebvre EA, Caravan P. Dual alphavbeta6 and alphavbeta1 Inhibition over 12 Weeks Reduces Active Type I Collagen Deposition in Individuals with Idiopathic Pulmonary Fibrosis: A Phase 2, Double-Blind, Placebo-controlled Clinical Trial. Am J Respir Crit Care Med. 2025 Jul;211(7):1229-1240. doi: 10.1164/rccm.202410-1934OC.
PubMed 40153543
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Evaluation of PLN-74809 on Type 1 Collagen Deposition Using 68Ga-CBP8 PET/MRI Imaging in Participants With Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT05621252
- Acronym / sponsor ID
- PLN-74809 / PLN-74809-IPF-205
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Pliant Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 18 Nov 2022 (actual)
- Results
- Posted 24 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2a, single -center, randomized, double-blind, placebo-controlled study to evaluate type 1 collagen deposition in the lungs following once-daily treatment with PLN-74809 for 12-weeks. This study is occurring at Massachusetts General Hospital.
Detailed description
This is a Phase 2a, single-center, randomized, double-blinded, placebo-controlled study to evaluate type 1 collagen deposition in the lungs of participants with Idiopathic Pulmonary Fibrosis (IPF) following once-daily (QD) treatment with 160 mg PLN-74809 for 12 weeks. The study consists of an up to 28-day screening period, a 12-week treatment period, and a 2 week (±3 days) post treatment follow-up period.
Approximately 12 eligible participants will be randomized in a 2:1 ratio (160 mg PLN-74809 vs placebo; approximately 8 receiving PLN-74809 and 4 receiving placebo) on Day 1 (Visit 3). Randomization will be stratified by use of standard of care IPF therapy with pirfenidone or nintedanib. PET/MRI scans will be conducted at Baseline and at Week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 2:1 randomization PLN-74809:placebo
| Arm | Type | Receives |
|---|---|---|
| PLN-74809 | Experimental | Drug: PLN-74809160 mg PLN-74809 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants, aged 40 years or older
- Diagnosis of IPF, within 8 years prior to Screening
- FVC % predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening
- Diffusing capacity for carbon monoxide DLco (hemoglobin-adjusted) ≥30%; historical DLco for entry in the study is permitted if within 1 month of Screening
- Participants currently receiving treatment for IPF with nintedanib or pirfenidone are permitted, 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 at Screening
- 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-74809160 mg PLN-74809 | Drug | PLN-74809 |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Primary Outcome
Time frame: 12 weeks
Change from Baseline in top quartile whole lung PET standardized uptake value (SUV) following 12 weeks of treatment with PLN-74809. The whole lung SUV measures the intensity of the uptake of the radiotracer, 68GA-CBP8: peptide-based collagen binding probe 8 tagged with Gallium-68 radioisotope, in lung tissue. A negative change from baseline is a positive outcome and represents a decrease in the whole lung SUV corresponding to a decrease in collagen deposition in the lung. A positive change from baseline is a negative outcome and represents an increase in the whole lung SUV corresponding to an increase in collagen deposition in the lung.
1 secondary outcome
Secondary Safety and Tolerability
Time frame: From screening period (up to 28 days) to treatment period of 12 weeks, to 2 weeks after last dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40153543Montesi SB, Cosgrove GP, Turner SM, Zhou IY, Efthimiou N, Susnjar A, Catana C, Fromson C, Clark A, Decaris M, Barnes CN, Lefebvre EA, Caravan P. Dual alphavbeta6 and alphavbeta1 Inhibition over 12 Weeks Reduces Active Type I Collagen Deposition in Individuals with Idiopathic Pulmonary Fibrosis: A Phase 2, Double-Blind, Placebo-controlled Clinical Trial. Am J Respir Crit Care Med. 2025 Jul;211(7):1229-1240. doi: 10.1164/rccm.202410-1934OC.
- 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.
Sydney Montesi, MD principal investigator
Massachusetts General Hospital
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 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 5 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 5 Dec 2025. 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. 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?
Yes. Results are posted in the registry (first posted 24 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?
Primary Outcome (time frame: 12 weeks). 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 NCT05621252, 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 5 Dec 2025.