Table of contents
- Overview of the trial
- Who the trial is for
- What the study is measuring
- Trial phase and status
- Treatment groups and study design
- Important terms explained
Overview of the trial
The trial titled “A study to find an efficacious and safe dose of CHF10067 (zampilimab) in participants with idiopathic pulmonary fibrosis” is studying ZAMPILIMAB in people with idiopathic pulmonary fibrosis (IPF).[1] It is an interventional study, which means researchers give a study treatment and compare results across groups.[1]
The main goal is to see whether two dose strengths of CHF10067 can improve lung function compared with placebo in the full study population.[1] The brief summary says the study is looking at the change from baseline in percent predicted forced vital capacity at Week 24.[1]
Who the trial is for
The target population is participants with idiopathic pulmonary fibrosis.[1] IPF is a lung disease that causes scarring and can make breathing harder over time.
The trial data provided here do not list extra entry rules, such as age limits or other medical requirements.[1]
What the study is measuring
The main endpoint is the change from baseline in percent predicted forced vital capacity (ppFVC) at Week 24.[1] This is a lung function measure that shows how much air a person can blow out after a deep breath, compared with what is expected for someone similar in age, sex, and size.
The study is also described as looking for an efficacious and safe dose, so the researchers are trying to understand both whether the treatment may work and whether it can be used safely in the study setting.[1]
Trial phase and status
This is a Phase 2 trial.[1] Phase 2 studies usually focus on early proof of effect and on safety in a larger group than Phase 1.
The trial status is Authorised, which means it has been approved to run.[1] The planned enrollment is 235 participants.[1]
Treatment groups and study design
The study includes ZAMPILIMAB given by intravenous infusion and a placebo-like comparison treatment of 0.9% sodium chloride aqueous solution for IV infusion.[1] The source data mention a dose of 3000.00 mg for ZAMPILIMAB.[1]
The brief summary says the study is comparing two dose strengths of CHF10067 against placebo in the entire study population.[1] In patient-friendly terms, this means researchers want to see which dose may give the best balance of benefit and safety.
Important terms explained
Interventional study means the researchers actively give a treatment instead of only observing what happens.[1] Baseline means the starting measurement before treatment begins.[1]
Placebo is a comparison treatment that does not contain the active study drug, used to help show whether the study treatment has a real effect.[1] Week 24 means 24 weeks after the study starts.[1]
Forced vital capacity is the amount of air a person can breathe out after taking the deepest breath possible.[1] Percent predicted means the result is compared with what is expected for a person with similar body characteristics.[1]
