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Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/ (IPF-201)

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ClinicalTrials.gov Identifier: NCT04072315
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : June 1, 2021
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Pliant Therapeutics, Inc.

Brief Summary:
A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: PLN-74809 Radiation: Knottin tracer Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label, up to 2 single doses administered at two different times
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: A Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021


Arm Intervention/treatment
Experimental: PLN-74809 Dose Level 1
PLN-74809 Dose Level 1
Drug: PLN-74809
PLN-74809

Radiation: Knottin tracer
Radiotracer

Experimental: PLN-74809 Dose Level 2
PLN-74809 Dose Level 2
Drug: PLN-74809
PLN-74809

Radiation: Knottin tracer
Radiotracer

Experimental: PLN-74809 Dose Level 3
PLN-74809 Dose Level 3
Drug: PLN-74809
PLN-74809

Radiation: Knottin tracer
Radiotracer

Experimental: PLN-74809 Dose Level 4
PLN-74809 Dose Level 4
Drug: PLN-74809
PLN-74809

Radiation: Knottin tracer
Radiotracer




Primary Outcome Measures :
  1. Number of participants with a change from baseline in αVβ6 receptor occupancy in the lung as measured by PET (positron emission tomography) scan. [ Time Frame: Following 1 day of dosing ]

Secondary Outcome Measures :
  1. Safety and tolerability of PLN-74809 as measured by the incidence of adverse events. [ Time Frame: From screening to 1 week following the administration of PLN-74809 ]
  2. Number of participants with serious adverse events by treatment and dose. [ Time Frame: From screening to 1 week following the administration of PLN-74809 ]

Other Outcome Measures:
  1. Relationship between PLN-74809 systemic exposure, αvβ6 receptor occupancy and biomarkers in IPF participants [ Time Frame: Following 1 day of administration of PLN-74809 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04072315


Contacts
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Contact: Pliant Therapeutics Medical Monitor clintrials@pliantrx.com clintrials@pliantrx.com

Locations
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United States, California
Stanford Medical Center Recruiting
Palo Alto, California, United States, 94305
Contact: Joshua Mooney, MD         
Contact: Henry Guo, MD         
Sponsors and Collaborators
Pliant Therapeutics, Inc.
Stanford University
Investigators
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Study Director: Pliant Therapeutics Medical Monitor Pliant Therapeutics, Inc.
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Responsible Party: Pliant Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04072315    
Other Study ID Numbers: PLN-74809-IPF-201
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Lung Diseases
Respiratory Tract Diseases