Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring IPF, idiopathic pulmonary fibrosis, pulmonary fibrosis, bexotegrast, Beacon, BEACON-IPF
Eligibility Criteria
Inclusion Criteria: ≥ 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 Criteria: 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)
Sites / Locations
- Paradigm Clinical Research Institute Inc - ClinEdge
- Clinical Site Partners - Leesburg
- IU Health Advanced Heart and Lung Care
- Creighton University
- PulmonIx, LLC
- Southeastern Research CenterRecruiting
- Bend Memorial Clinic/Summit Medical Group - Eastside
- Clinical Research Associates Of Central PA , LLC
- University of Pittsburgh Medical Center
- Lowcountry Lung and Critical Care PA
- Clinical Trials Center of Middle Tennessee
- El Paso Pulmonary Association
- Metroplex Pulmonary and Sleep Medicine CenterRecruiting
- Research Centers of AmericaRecruiting
- University of Utah
- Institute for Respiratory Health - Midland
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Placebo
Bexotegrast (PLN-74809) 160 mg Dose
Bexotegrast (PLN-74809) 320 mg Dose
Placebo
Bexotegrast (PLN-74809) 160 mg Dose - 52 weeks
Bexotegrast (PLN-74809) 320 mg Dose - 52 weeks