Phase 2 Cystic Fibrosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Primary Study:

• Adults aged 18 or older
• People with a confirmed diagnosis of cystic fibrosis (CF) with lung disease, shown by a sweat chloride test result of 60 mmol/L or higher, and either two CF gene mutations or one CF gene mutation with signs of CF lung disease
• People who are not eligible for CFTR modulator therapy (a type of CF medication), or who tried it but had to stop because of side effects
• People whose lung function (a breathing test called FEV1) falls between 50% and 90% of what is expected for someone of their age, height, and sex
• People whose blood oxygen level is 92% or higher while breathing normal room air

Sub-Study:

• Adults aged 18 or older
• People with a confirmed diagnosis of CF with lung disease, shown by a sweat chloride test result of 60 mmol/L or higher, and either two CF gene mutations or one CF gene mutation with signs of CF lung disease
• People who have been on a stable dose of CFTR modulator therapy for at least 60 days before the screening visit, and who agree to stay on the same dose throughout the 24-month observation period
• People whose lung function (FEV1) is between 40% and below 70% of what is expected, and/or who have had at least 2 serious lung infections in the past year requiring intravenous (IV) antibiotics

Who may not be able to join:

• People who have previously received any form of gene therapy for any condition (note: mRNA-based or antisense oligonucleotide treatments are not excluded — confirm with trial site)
• People who currently have an active Mycobacterium abscessus infection that is being treated
• People with active allergic bronchopulmonary aspergillosis (a fungal lung condition) that is being managed with steroid tablets or antifungal medication
• People who have smoked cigarettes, cigars, or cannabis, or used vaping products in the two months before screening, or who are unwilling to avoid these during the screening period and the first 24 months of the study
• People for whom steroid medication (taken by mouth or injection) is not medically appropriate
• People who need to take steroid tablets or immune-suppressing medications on an ongoing basis for another health condition
• People without a known diagnosis of CF-related diabetes, Type 1 or Type 2 diabetes, whose blood sugar control test (HbA1c) result is 6.5% or higher at screening
• People with a known diagnosis of CF-related diabetes, Type 1 or Type 2 diabetes, whose HbA1c result is above 7.5% at screening
• People who have recently had symptoms of high blood sugar or unstable blood sugar levels, as assessed by the study doctor
• People with other conditions that the study doctor believes could make it difficult to manage blood sugar problems that may be caused by steroid treatment
• People with a Body Mass Index (BMI) below 16 (a measure of body weight relative to height)
• People whose blood test results at screening show significantly elevated liver enzymes (ALT, AST, or GGT at three or more times the normal upper limit), elevated bilirubin (a liver marker at two or more times the normal upper limit), or low haemoglobin (below 10 g/dL, a measure of red blood cell levels)
• People who need continuous or overnight oxygen support
• People with known CF-related liver disease involving advanced scarring (multilobular cirrhosis)
• People with a history of blood clots (not related to a medical catheter), or conditions that significantly increase the risk of blood clots

Important: Always verify eligibility with the trial site directly before applying.