IRB Study Number 23-1142
Status Recruiting
Phase Phase 2
Location Cleveland Clinic Main Campus
Institute Respiratory Institute
Description
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).
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)
