Phase 2 Cystic Fibrosis Trial, Recruiting

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

Who might be able to join this trial:

Cohorts 1–3 (without CFTR modulator therapy)

• People with a diagnosis of cystic fibrosis (CF) who carry a specific genetic mutation called 3849+10 Kb C->T on at least one copy of the CFTR gene, confirmed by a certified genetic testing laboratory.
• People with a body mass index (BMI) of 17 or above.
• People whose lung function test (called FEV1) falls between 40% and 90% of what is considered normal for their age and size, measured at the screening visit.
• People who have not smoked or vaped for at least 6 months before the screening visit, based on their own report.

Cohort 4 (with CFTR modulator therapy)

• People with a diagnosis of CF who carry the specific 3849+10 Kb C->T genetic mutation on at least one copy of the CFTR gene, confirmed by a certified genetic testing laboratory.
• People with a BMI of 17 or above.
• People whose FEV1 lung function result falls between 40% and 80% of predicted at screening.
• People who have not smoked or vaped for at least 6 months before the screening visit, based on their own report.
• People who have been consistently taking Trikafta/Kaftrio or Alyftrek for at least 3 months, or Alyftrek for at least 1 month after switching from Trikafta/Kaftrio, as directed by prescribing information.

Who may not be able to join:

Cohorts 1–3

• People who have taken CF medicines called Kalydeco, Orkambi, Symdeko/Symkevi, or Trikafta/Kaftrio within 30 days before the first study dose.
• People who have taken another experimental drug or used an experimental medical device (other than SPL84) within 30 days before the first study dose.
• People who have used steroid tablets or injections for more than 3 months in a row during the past 6 months, or used them at all in the month before screening; or people using inhaled steroids at a dose above 1 mg.
• People whose CF-related medicines (such as inhaled antibiotics, Pulmozyme, hypertonic saline, or physiotherapy routines) have not been on a stable and unchanged routine for at least 28 days before screening; people taking inhaled antibiotics as a preventive measure must have been on a stable dose for at least 90 days before the first study dose.
• People who have had any active infection — including chest or airway infections, a CF flare-up, or any other illness requiring new treatment — within 14 days before the first study dose.
• People who have coughed up more than 30 mL of blood in the 90 days before the study starts, or who have been hospitalised for coughing up blood within 6 months before the first study dose.
• People with significant liver disease, including serious scarring of the liver (cirrhosis) or high blood pressure in the liver's blood vessels (portal hypertension).
• People who have previously had an organ transplant.
• People who have had a confirmed COVID-19 infection within 4 weeks before dosing begins.

Cohort 4 (additional exclusion)

• People who previously participated in the active treatment group of the related SPL84-002 study (Cohorts 1–3).
• All other exclusion criteria listed above for Cohorts 1–3 also apply to Cohort 4.

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