A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF)
- Conditions
- Idiopathic pulmonary fibrosis (IPF)MedDRA version: 20.0Level: LLTClassification code: 10067761Term: Exacerbation of idiopathic pulmonary fibrosis Class: 10038738MedDRA version: 21.1Level: PTClassification code: 10021240Term: Idiopathic pulmonary fibrosis Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2023-506185-31-00
- Lead Sponsor
- Pliant Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 769
1. = 40 years of age prior to screening, 2. IPF diagnosis = 7 years prior to screening based upon American Thoracic Society / European Respiratory Society / Japanese Respiratory Society / Latin American Thoracic Association 2018 guidelines and confirmed with central review (Raghu et al 2018). A HRCT scan performed = 2 years may be used for eligibility., 3. FVCpp = 45%, 4. Diffusing capacity for carbon monoxide percent predicted (DLCOpp) (hemoglobin-adjusted) = 30% and < 90%, 5. Current treatment for IPF with background therapy is allowed, if at a stable dose for = 12 weeks prior to screening
1. Receiving pharmacologic therapy for pulmonary hypertension, 2. Forced expiratory volume in the FEV1/FVC ratio < 0.7 at screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To characterize the effect of bexotegrast versus placebo on the change in FVC in participants with idiopathic pulmonary fibrosis (IPF) at Week 52;Secondary Objective: To characterize the effect of bexotegrast versus placebo over 52 weeks of treatment on disease progression, To characterize the effect of bexotegrast versus placebo after 52 weeks of treatment on overall symptom and functional improvement associated with IPF, To characterize the effect of bexotegrast versus placebo on change in lung fibrosis by high-resolution computed tomography (HRCT) at Week 52, To characterize the safety and tolerability of bexotegrast versus placebo in participants with IPF over 52 weeks of treatment;Primary end point(s): Change from baseline in absolute FVC (mL) at Week 52
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Time to disease progression, defined as time to first occurrence of = 10% absolute decline from baseline in forced vital capacity percent predicted (FVCpp), respiratory-related hospitalization, or all-cause mortality through Week 52;Secondary end point(s):Proportion of participants with a = 10% absolute decline from baseline in FVCpp or all-cause mortality through Week 52;Secondary end point(s):Change from baseline in L-PF Dyspnoea Domain score at Week 52;Secondary end point(s):Change from baseline in L-PF Cough Domain score at Week 52;Secondary end point(s):Change from baseline in King’s Brief Interstitial Lung Disease (K-BILD) questionnaire Total score at Week 52;Secondary end point(s):Absolute change from baseline in quantitative lung fibrosis extent (%) at Week 52;Secondary end point(s):Proportion of participants with treatment-emergent adverse events and serious adverse events