Status:
TERMINATED
Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis
Lead Sponsor:
Pliant Therapeutics, Inc.
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF).
Detailed Description
This is a randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of 2 doses of bexotegrast (PLN-74809) \[160 and 320 mg\] taken for 52 weeks by participan...
Eligibility Criteria
Inclusion
- ≥ 40 years of age prior to screening
- IPF diagnosis ≤ 7 years prior to screening
- FVCpp ≥ 45%
- Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥ 30% and \< 90%
- Current treatment for IPF with background therapy is allowed, if at a stable dose for ≥ 12 weeks prior to screening
- If not currently receiving treatment for IPF (either treatment naïve or discontinued prior treatment), participant must not have taken background therapy for at least 8 weeks prior to screening
Exclusion
- Receiving pharmacologic therapy for pulmonary hypertension
- Self-reported smoking of any kind (not limited to tobacco)
- History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, resected noninvasive cutaneous squamous cell carcinoma, or treated cervical carcinoma in situ
- Hepatic impairment or end-stage liver disease
- Renal impairment or end-stage kidney disease requiring dialysis
- Pregnant or lactating female participant
- Uncontrolled systemic arterial hypertension
- Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF
- Prior administration of bexotegrast
- Likely to have lung transplantation during the study (being on transplantation list is not an exclusion)
- Forced expiratory volume in the first second (FEV1)/FVC ratio \<0.7 at screening
- Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization
- Known acute IPF exacerbation, or suspicion by the Investigator of such, 6 months prior to screening
Key Trial Info
Start Date :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2025
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT06097260
Start Date
November 16 2023
End Date
April 4 2025
Last Update
August 1 2025
Active Locations (268)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Arizona Pulmonary Specialists
Phoenix, Arizona, United States, 85012
3
Dignity Health-St. Josephs Hospital and Medical Center
Phoenix, Arizona, United States, 85013
4
Banner University Medical Center
Tucson, Arizona, United States, 85724