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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PLN-74809
Knottin tracer
Sponsored by
Pliant Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

PLN-74809 Dose Level 1

PLN-74809 Dose Level 2

PLN-74809 Dose Level 3

PLN-74809 Dose Level 4

Arm Description

PLN-74809 Dose Level 1

PLN-74809 Dose Level 2

PLN-74809 Dose Level 3

PLN-74809 Dose Level 4

Outcomes

Primary Outcome Measures

Number of participants with a change from baseline in αVβ6 receptor occupancy in the lung as measured by PET (positron emission tomography) scan.

Secondary Outcome Measures

Safety and tolerability of PLN-74809 as measured by the incidence of adverse events.
Number of participants with serious adverse events by treatment and dose.

Full Information

First Posted
August 23, 2019
Last Updated
November 15, 2022
Sponsor
Pliant Therapeutics, Inc.
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04072315
Brief Title
Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/
Acronym
IPF-201
Official Title
A Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
July 5, 2022 (Actual)
Study Completion Date
July 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pliant Therapeutics, Inc.
Collaborators
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Open label, up to 2 single doses administered at two different times
Masking
None (Open Label)
Masking Description
No masking
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PLN-74809 Dose Level 1
Arm Type
Experimental
Arm Description
PLN-74809 Dose Level 1
Arm Title
PLN-74809 Dose Level 2
Arm Type
Experimental
Arm Description
PLN-74809 Dose Level 2
Arm Title
PLN-74809 Dose Level 3
Arm Type
Experimental
Arm Description
PLN-74809 Dose Level 3
Arm Title
PLN-74809 Dose Level 4
Arm Type
Experimental
Arm Description
PLN-74809 Dose Level 4
Intervention Type
Drug
Intervention Name(s)
PLN-74809
Intervention Description
PLN-74809
Intervention Type
Radiation
Intervention Name(s)
Knottin tracer
Intervention Description
Radiotracer
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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 Pre-specified Outcome Measures:
Title
Relationship between PLN-74809 systemic exposure, αvβ6 receptor occupancy and biomarkers in IPF participants
Time Frame
Following 1 day of administration of PLN-74809

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pliant Therapeutics Medical Monitor
Organizational Affiliation
Pliant Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Stanford Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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