Idiopathic Pulmonary FibrosisPhase 2NCT04396756
Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
A Phase 2 study testing PLN-74809 in people with Idiopathic Pulmonary Fibrosis, run by Pliant Therapeutics, Inc. at 20 sites in 7 countries.
Trial summary
A Phase 2a, multicenter, 4-part, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and PK of once-daily treatment with PLN-74809 in participants with idiopathic pulmonary fibrosis. 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
- 120 participants
- Where
- 20 sitesin 7 countries
- Study dates
- 3 Mar 2020to 15 Feb 2023
- 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 based upon the Fleischner Society guidelines within 3 years from Screening (Part A) or based on ATS/ERS/JRS/ALAT 2018 guidelines within 5 years from Screening (Part B, C \& D)
- FVC % of predicted ≥45%
- DLco (hemoglobin-adjusted) ≥30%
- 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 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
20 sites in 7 countries.
20 sites in 7 countries
United States10 sites
The Emory Clinic
Atlanta, Georgia, 30322
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Cardio-Pulmonary Associates of St. Luke's Hospital - Chesterfield
Chesterfield, Missouri, 63017-3625
PulmonIx
Greensboro, North Carolina, 27403
Baylor College of Medicine
Houston, Texas, 77030
Cedars-Sinai Medical Center, Interstitial Lung Disease Program, Pulmonary and Critical Care Medicine
Los Angeles, California, 90048
Vanderbilt Lung Institute at One Hundred Oaks
Nashville, Tennessee, 37204
Yale University Scool of Medicine/ Yale New Haven Hospital
New Haven, Connecticut, 06510
Pulmonary Associates, PA
Phoenix, Arizona, 85032
UPMC
Pittsburgh, Pennsylvania, 15213
Australia2 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
The Alfred Hospital
Melbourne, Victoria, 3004
Canada2 sites
CISSS de la Montérégie Centre
Greenfield Park, Quebec, J4V 2H1
Dr. Anil Dhar Medicine Professional Corporation
Windsor, Ontario, N8X 5A6
Netherlands2 sites
Catharina Ziekenhuis
Eindhoven, EJ, 5623
Canisius-Wilhelmina Ziekenhuis
Nijmegen, SZ, 6532
New Zealand2 sites
University of Otago Christchurch
Christchurch, 8011
New Zealand Respiratory and Sleep Institute
Greenlane, Auckland, 1051
About this study
Official title: A Randomized, Double-blind, Dose-ranging, Placebo Controlled Phase 2a Evaluation of the Safety, Tolerability and Pharmacokinetics of PLN-74809 in Participants With Idiopathic Pulmonary Fibrosis (INTEGRIS-IPF)
A Phase 2a, multicenter, 4-part, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and PK of once-daily treatment with PLN-74809 in participants with idiopathic pulmonary fibrosis.
Read the detailed description
Four part study:
Part A - 4 week treatment period evaluating PLN-74809 or matching placebo
Part B - 12 week treatment period evaluating PLN-74809 or matching placebo
Part C - 12 week treatment period evaluating up to two intermediatery PLN-74809 doses or matching placebo
Part D - ≥ 24 week treatment period evaluating higher PLN-74809 dose or matching placebo
- 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
PLN-74809
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Placebo Receives: Drug: Placebo |
| PLN-74809 Dose Level 1 (Part A) | Experimental | PLN-74809 Dose Level 1 (Part A) - 4 weeks Receives: Drug: PLN-74809 |
| PLN-74809 Dose Level 2 (Part A) | Experimental | PLN-74809 Dose Level 2 (Part A) - 4 weeks Receives: Drug: PLN-74809 |
| PLN-74809 Dose Level 2 (Part B) | Experimental | PLN-74809 Dose Level 2 (Part B) - 12 weeks Receives: Drug: PLN-74809 |
| PLN-74809 - Dose Level 3 (Part C) | Experimental | PLN-74809 Dose Level 3 (Part C) - 12 weeks Receives: Drug: PLN-74809 |
| PLN-74809 - Dose Level 4 (Part C) | Experimental | PLN-74809 Dose Level 4 (Part C) - 12 weeks Receives: Drug: PLN-74809 |
| PLN-74809 - Dose Level 5 (Part D) | Experimental | PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks Receives: Drug: PLN-74809 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A - Number of Participants With Treatment-Emergent Adverse Events
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
Measured: Up to 4 weeks
Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
Measured: Up to 12 weeks
Part D - Number of Participants With Treatment-Emergent Adverse Events
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
Measured: Up to 48 weeks
Part A - Number of Participants With Serious Treatment-Emergent Adverse Events
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Measured: Up to 4 weeks
Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Measured: Up to 12 weeks
Part D - Number of Participants With Serious Treatment-Emergent Adverse Events
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Measured: Up to 48 weeks
Secondary outcomes (3)
Part A - Assessment of PLN-74809 Total Plasma Concentrations
Part A - Assessment of PLN-74809 Total Plasma Concentrations Week 4, 1 Hour Post Dose
Measured: Week 4, 1 Hour Post Dose
Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations
Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations Week 12, 2 Hours Post Dose
Measured: Week 12, 2 Hours Post Dose
Part D - Assessment of PLN-74809 Total Plasma Concentrations
Part D - Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hours Post Dose
Measured: Week 24, 2 Hours Post Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start3 Mar 2020
- Primary completion1 Feb 2023
- Study completion15 Feb 2023
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pliant Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pliant Therapeutics Medical Monitor, Study director, Pliant Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396756
- Sponsor's protocol ID
- PLN-74809-IPF-202
- Other IDs
- INTEGRIS-IPF
- Status last verified
- Feb 2024
- First submitted
- 6 May 2020
- Last updated
- 3 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lancaster L, Cottin V, Ramaswamy M, Wuyts WA, Jenkins RG, Scholand MB, Kreuter M, Valenzuela C, Ryerson CJ, Goldin J, Kim GHJ, Jurek M, Decaris M, Clark A, Turner S, Barnes CN, Achneck HE, Cosgrove GP, Lefebvre EA, Flaherty KR; PLN-74809-IPF-202 Trial Investigators. Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis: The INTEGRIS-IPF Clinical Trial. Am J Respir Crit Care Med. 2024 Aug 15;210(4):424-434. doi: 10.1164/rccm.202403-0636OC.
PubMed 38843105
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Dose-ranging, Placebo Controlled Phase 2a Evaluation of the Safety, Tolerability and Pharmacokinetics of PLN-74809 in Participants With Idiopathic Pulmonary Fibrosis (INTEGRIS-IPF)
- ClinicalTrials.gov ID
- NCT04396756
- Acronym / sponsor ID
- PLN-74809-IPF-202
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Pliant Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Posted 30 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2a, multicenter, 4-part, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and PK of once-daily treatment with PLN-74809 in participants with idiopathic pulmonary fibrosis.
Detailed description
Four part study:
Part A - 4 week treatment period evaluating PLN-74809 or matching placebo
Part B - 12 week treatment period evaluating PLN-74809 or matching placebo
Part C - 12 week treatment period evaluating up to two intermediatery PLN-74809 doses or matching placebo
Part D - ≥ 24 week treatment period evaluating higher PLN-74809 dose or matching placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: PlaceboPlacebo |
| PLN-74809 Dose Level 1 (Part A) | Experimental | Drug: PLN-74809PLN-74809 Dose Level 1 (Part A) - 4 weeks |
| PLN-74809 Dose Level 2 (Part A) | Experimental | Drug: PLN-74809PLN-74809 Dose Level 2 (Part A) - 4 weeks |
| PLN-74809 Dose Level 2 (Part B) | Experimental | Drug: PLN-74809PLN-74809 Dose Level 2 (Part B) - 12 weeks |
| PLN-74809 - Dose Level 3 (Part C) | Experimental | Drug: PLN-74809PLN-74809 Dose Level 3 (Part C) - 12 weeks |
| PLN-74809 - Dose Level 4 (Part C) | Experimental | Drug: PLN-74809PLN-74809 Dose Level 4 (Part C) - 12 weeks |
| PLN-74809 - Dose Level 5 (Part D) | Experimental | Drug: PLN-74809PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks |
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 based upon the Fleischner Society guidelines within 3 years from Screening (Part A) or based on ATS/ERS/JRS/ALAT 2018 guidelines within 5 years from Screening (Part B, C \& D)
- FVC % of predicted ≥45%
- DLco (hemoglobin-adjusted) ≥30%
- 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 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-74809PLN-74809 | Drug | PLN-74809 - Dose Level 3 (Part C), PLN-74809 - Dose Level 4 (Part C), PLN-74809 - Dose Level 5 (Part D), PLN-74809 Dose Level 1 (Part A), PLN-74809 Dose Level 2 (Part A), PLN-74809 Dose Level 2 (Part B) |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Part A - Number of Participants With Treatment-Emergent Adverse Events
Time frame: Up to 4 weeks
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events
Time frame: Up to 12 weeks
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
Part D - Number of Participants With Treatment-Emergent Adverse Events
Time frame: Up to 48 weeks
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
Part A - Number of Participants With Serious Treatment-Emergent Adverse Events
Time frame: Up to 4 weeks
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events
Time frame: Up to 12 weeks
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Part D - Number of Participants With Serious Treatment-Emergent Adverse Events
Time frame: Up to 48 weeks
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
3 secondary outcomes
Part A - Assessment of PLN-74809 Total Plasma Concentrations
Time frame: Week 4, 1 Hour Post Dose
Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations
Time frame: Week 12, 2 Hours Post Dose
Part D - Assessment of PLN-74809 Total Plasma Concentrations
Time frame: Week 24, 2 Hours Post Dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38843105Lancaster L, Cottin V, Ramaswamy M, Wuyts WA, Jenkins RG, Scholand MB, Kreuter M, Valenzuela C, Ryerson CJ, Goldin J, Kim GHJ, Jurek M, Decaris M, Clark A, Turner S, Barnes CN, Achneck HE, Cosgrove GP, Lefebvre EA, Flaherty KR; PLN-74809-IPF-202 Trial Investigators. Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis: The INTEGRIS-IPF Clinical Trial. Am J Respir Crit Care Med. 2024 Aug 15;210(4):424-434. doi: 10.1164/rccm.202403-0636OC.
- 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.
20 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 PLN-74809 in people with Idiopathic Pulmonary Fibrosis, run by Pliant Therapeutics, Inc. at 20 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 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 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Australia, Canada, Netherlands, New Zealand 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 30 Apr 2024). 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?
Part A - Number of Participants With Treatment-Emergent Adverse Events (time frame: Up to 4 weeks). The study lists 6 primary outcomes in all. 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 NCT04396756, 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 3 Jun 2024.