Phase 2a Evaluation of PLN-74809 on avß6 Receptor Occupancy Using PET Imaging in Participants With IPF/

• Register: ClinicalTrials.gov
• Last refreshed on: 28 November 2022
• Main ID: NCT04072315
• Date of registration: 23/08/2019
• Prospective Registration: Yes
• Primary sponsor: Pliant Therapeutics, Inc.
• Public title: Phase 2a Evaluation of PLN-74809 on avß6 Receptor Occupancy Using PET Imaging in Participants With IPF/ IPF-201
• Scientific title: A Phase 2a Evaluation of PLN-74809 on avß6 Receptor Occupancy Using PET Imaging in Participants With IPF
• Date of first enrolment: September 9, 2019
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04072315
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Pliant Therapeutics Medical Monitor
• Affiliation: Pliant Therapeutics, Inc.

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Radiation: Knottin tracer

Drug: PLN-74809

Primary Outcome(s)

Number of participants with a change from baseline in aVß6 receptor occupancy in the lung as measured by PET (positron emission tomography) scan. [Time Frame: Following 1 day of dosing]

Secondary Outcome(s)

Number of participants with serious adverse events by treatment and dose. [Time Frame: From screening to 1 week following the administration of PLN-74809]

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]

Secondary ID(s)

PLN-74809-IPF-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Stanford University