Table of contents
- Trial overview
- Condition and target population
- Study design and comparison
- What the trial measures
- Status and enrollment
Trial overview
The available data describe one interventional clinical trial studying HUMANISED IGG1 LALAPS-YTE MONOCLONAL ANTIBODY AGAINST LYSOPHOSPHATIDIC ACID RECEPTOR 1 in people with idiopathic pulmonary fibrosis.[1] The study is designed to evaluate safety, tolerability, and efficacy in adult participants.[1]
Condition and target population
The trial targets idiopathic pulmonary fibrosis, a chronic lung disease listed as the condition under study.[1] The study summary says it is for adult subjects, so the population is adults rather than children.[1]
Study design and comparison
This study includes HUMANISED IGG1 LALAPS-YTE MONOCLONAL ANTIBODY AGAINST LYSOPHOSPHATIDIC ACID RECEPTOR 1 given by intravenous administration and also includes a placebo for ABBV-142 as the comparison treatment.[1] A placebo is a look-alike treatment without the active study drug, used to help compare results fairly.[1]
The brief summary says the study aims to evaluate the investigational products as monotherapy or in combinations in adult subjects with idiopathic pulmonary fibrosis.[1] Monotherapy means one treatment used alone, while combinations means the study may look at more than one investigational approach.[1]
What the trial measures
The main outcome is the absolute change from baseline in forced vital capacity at Week 24.[1] Forced vital capacity is a breathing test that measures how much air a person can blow out after taking a deep breath.[1]
The study also looks at adverse events and change in disease activity, which helps researchers understand both safety and possible benefit.[1] Baseline means the starting point before treatment begins, so the result shows how much the lung function changes over 24 weeks.[1]
Status and enrollment
The trial status is Authorised, which means it has been approved to proceed according to the data provided.[1] The planned enrollment is 165 participants.[1]
Key points for patients
The study is focused on adults with idiopathic pulmonary fibrosis, not on other lung diseases.[1]
It is a Phase 2 trial, so it is meant to learn more about benefit and safety in a larger group than early-stage studies.[1]
The trial compares the study treatment with placebo, which helps show whether any changes are linked to the treatment itself.[1]
The main result is based on lung function after 24 weeks, using forced vital capacity.[1]
