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

Sponsor
Pliant Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04072315
Collaborator
Stanford University (Other)
12
Enrollment
1
Location
4
Arms
23.8
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Open label, up to 2 single doses administered at two different timesOpen 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 :
Sep 9, 2019
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

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

Outcome Measures

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. [Following 1 day of dosing]

Secondary Outcome Measures

  1. Safety and tolerability of PLN-74809 as measured by the incidence of adverse events. [From screening to 1 week following the administration of PLN-74809]

  2. Number of participants with serious adverse events by treatment and dose. [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 [Following 1 day of administration of PLN-74809]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford Medical Center Palo Alto California United States 94305

Sponsors and Collaborators

  • Pliant Therapeutics, Inc.
  • Stanford University

Investigators

  • Study Director: Pliant Therapeutics Medical Monitor, Pliant Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pliant Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04072315
Other Study ID Numbers:
  • PLN-74809-IPF-201
First Posted:
Aug 28, 2019
Last Update Posted:
Jun 1, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis

Study Results

No Results Posted as of Jun 1, 2021