A Phase 2a Study to Evaluate the Safety and Efficacy of ABBV-142 in Adults with Idiopathic Pulmonary Fibrosis

The primary objective of this phase 2a study is to evaluate the safety, tolerability, and efficacy of a humanised IgG1 LALAPS-YTE monoclonal antibody against lysophosphatidic acid receptor 1, administered as monotherapy or in combination, in adult subjects diagnosed with idiopathic pulmonary fibrosis.

The study involves 80 adult participants diagnosed with idiopathic pulmonary fibrosis. The population includes both male and female subjects within specific age categories. Inclusion requires a diagnosis confirmed via high-resolution computed tomography or histological evidence demonstrating a usual interstitial pneumonia pattern. Eligible individuals must have a forced vital capacity of at least 45% of the predicted normal and a diffusing capacity of the lungs for carbon monoxide of 25% or greater. Participants may be undergoing stable antifibrotic treatment or may have undergone a recent period without such therapy.

This Phase 2a, multicenter study evaluates the safety, tolerability, and efficacy of a humanised igg1 lalaps-yte monoclonal antibody against lysophosphatidic acid receptor 1 administered via intravenous administration or a placebo for the treatment of idiopathic pulmonary fibrosis. The study design involves a comparison of the investigational product against a placebo to assess changes in disease activity. Participants undergo a screening visit to confirm eligibility based on age, clinical diagnosis via high-resolution computed tomography, and specific pulmonary function parameters, including forced vital capacity and diffusing capacity of the lungs for carbon monoxide. The primary endpoint is the absolute change from baseline in forced vital capacity at Week 24, with additional secondary endpoints evaluating lung function through Week 52. The research methodology includes monitoring for adverse events and disease progression over the course of the trial.

The investigational product consists of a humanised IgG1 lalaps-yte monoclonal antibody against lysophosphatidic acid receptor 1. This substance is provided as a solution for injection/infusion intended for intravenous administration.

A placebo is utilized as a comparator in this clinical study.

Efficacy in subjects with idiopathic pulmonary fibrosis will be evaluated using various pulmonary function parameters. The primary endpoint is the absolute change from baseline in forced vital capacity (mL) at Week 24.

Secondary endpoints include the following assessments:

• Absolute change from baseline in FVC (mL) at Week 52.
• Relative change from baseline in FVC (mL) at Week 24 and Week 52.
• Absolute and relative change from baseline in FVC % predicted at Week 24 and Week 52.
• Time to first ≥ 10% absolute decline in FVC % predicted.
• Time to first ≥ 5% absolute decline in FVC % predicted.