Table of Contents
- Trials overview
- Study design and treatment groups
- Who can participate
- What is being measured
- Trial status and size
Trials overview
The available trial data show one interventional study of SARACATINIB in people with Fibrodyplasia Ossificans Progressiva (FOP).[1] The study is designed to judge safety, tolerability, and the effect on abnormal bone formation.[1]
Study design and treatment groups
This trial is listed as Phase 2, which means it is looking more closely at whether the treatment may help and is still monitoring safety.[1] The study compares SARACATINIB with placebo, which is a look-alike tablet without the study drug.[1]
The intervention list names AZD0530 and SARACATINIB together, and the title also uses the name sarcatinib in lower case, but the drug name in this article is kept exactly as SARACATINIB as requested.[1] The source data also says the medicine is given orally, meaning by mouth.[1]
Who can participate
The trial is for patients with FOP, the condition named in the record.[1] The source data does not list more detailed entry rules, such as age limits or other medical requirements.[1]
What is being measured
The main safety measure is the incidence and severity of treatment-emergent adverse events, which means how often side effects happen and how serious they are after treatment starts.[1] The main efficacy measure is the number of new lesions, meaning new areas of abnormal bone formation.[1]
The study checks these new lesions using [18F]-NaF PET and CT at week 26.[1] PET is an imaging scan that can show active changes in the body, and CT is a scan that gives detailed pictures of body structures.[1]
Trial status and size
The trial status is listed as Authorised.[1] The planned enrollment is 18 people, which means 18 participants are expected to join.[1]
The brief summary says the study aims to assess the effectivity of treatment with AZD0530 on HO formation, where HO means abnormal bone formation in this trial record.[1]
