Table of contents
- Trial overview
- Who can participate
- Study design and treatment groups
- What is being measured
- Trial status and size
- Key terms for patients
Trial overview
The available study is an interventional trial, which means researchers give a study treatment and then measure what happens.[1] It is testing HUMANISED IGG1 LALAPS-YTE MONOCLONAL ANTIBODY AGAINST LYSOPHOSPHATIDIC ACID RECEPTOR 1 in adults with idiopathic pulmonary fibrosis, also called IPF.[1] The brief goal is to evaluate safety, tolerability, and efficacy, either as monotherapy or in combinations, in adult people with IPF.[1]
Who can participate
This trial is for adult participants with idiopathic pulmonary fibrosis.[1] The source data do not list more detailed entry rules, such as exact lung function limits or other medical requirements.[1]
Study design and treatment groups
The study is a Phase 2 trial.[1] Phase 2 studies are usually done after early testing and are used to see whether a treatment shows signs of benefit while continuing to watch safety.[1] The treatment plan includes HUMANISED IGG1 LALAPS-YTE MONOCLONAL ANTIBODY AGAINST LYSOPHOSPHATIDIC ACID RECEPTOR 1 and a placebo for ABBV-142, which is a look-alike comparison treatment with no active study drug.[1]
The trial title and summary show that the study is looking at adverse events and change in disease activity in adults with IPF.[1] The study is also described as assessing the investigational products as monotherapy or in combinations.[1]
What is being measured
The main outcome is the absolute change from baseline in forced vital capacity at Week 24.[1] Forced vital capacity is the amount of air a person can blow out after taking the deepest breath possible, and baseline means the starting point before treatment begins.[1] This outcome helps researchers see whether lung function changes over time during the study.[1]
The study summary also says the researchers want to evaluate safety, tolerability, and efficacy.[1] In simple terms, they want to know if the treatment can be given safely, whether people can handle it, and whether it may help the disease.[1]
Trial status and size
The trial status is Authorised, which means it has official approval to proceed.[1] The planned enrollment is 165 participants.[1] This gives the study enough people to compare results and look for meaningful changes in lung function and disease activity.[1]
Key terms for patients
Idiopathic pulmonary fibrosis is a lung disease that causes scarring, and the cause is not known.[1] Adverse events are unwanted medical problems that happen during a study.[1] Tolerability means how well people can handle the study treatment.[1]
Efficacy means how well a treatment works for the condition being studied.[1] Monotherapy means the treatment is given by itself, while combinations mean it may be studied with other treatments.[1] Placebo is a comparison treatment that looks like the study drug but has no active study medicine.[1]
