Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/
Trial ID or NCT#
NCT04072315
Status
NOT RECRUITING
Purpose
A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement.
Official Title
A Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF
Eligibility Criteria
Ages Eligible for Study: Older than 40 Years
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
Investigator(s)
Joshua Mooney
Pulmonologist,
Interstitial lung disease specialist,
Lung transplant specialist,
Heart and lung transplant specialist
Clinical Assistant Professor, Medicine - Pulmonary, Allergy & Critical Care Medicine
Contact us to find out if this trial is right for you.
Contact
Joshua Mooney, MD
View on ClinicalTrials.gov
