Status:
COMPLETED
Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/
Lead Sponsor:
Pliant Therapeutics, Inc.
Collaborating Sponsors:
Stanford University
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04072315
Start Date
February 13 2020
End Date
July 5 2022
Last Update
December 12 2023
Active Locations (1)
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1
Stanford Medical Center
Palo Alto, California, United States, 94305