Find Acute Interstitial Pneumonia Clinical Trials Near You
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of PIPE-791 in subjects with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:
• Male or female ≥ 40 years of age at the time of Randomization
• A diagnosis of IPF within 7 years prior to Screening, based on the 2018 ATS/ERS/JRS/ALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT with verification of usual interstitial pneumonia
• Percent predicted (pp) FVC ≥ 40% on Screening spirometry
• Subjects may enter the study whether or not they are receiving background antifibrotic therapy, approved for the treatment of IPF (nintedanib or pirfenidone, but not both concurrently)
Locations
Other Locations
Australia
The Alfred Hospital
RECRUITING
Melbourne
Institute for Respiratory Health
RECRUITING
Midland
TrialsWest Pty Ltd
RECRUITING
Spearwood
Westmead Hospital
RECRUITING
Westmead
Canada
Dynamic Drug Advancement Ltd.
RECRUITING
Ajax
Centre d'investigation Clinique Mauricie
RECRUITING
Trois-rivières
Vancouver General Hospital
RECRUITING
Vancouver
Dr. Anil Dhar Medicine Professional Corporation
RECRUITING
Windsor
Israel
Assuta Ashdod University Medical Center
RECRUITING
Ashdod
The Barzilai University Medical Center
RECRUITING
Ashkelon
Shamir Medical Center
RECRUITING
Be’er Ya‘aqov
Hillel Yaffe Medical Center
RECRUITING
Hadera
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Rabin Medical Center - PPDS
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center - PPDS
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center Ichilov - PPDS
RECRUITING
Tel Aviv
New Zealand
Canterbury Respiratory Research Group
RECRUITING
Christchurch
Greenlane Clinical Centre
RECRUITING
Epsom
Health New Zealand - Te Whatu Ora - Waikato Hospital