Trials Tracker

A Phase 2 study of ABBV-3067 alone and in combination with ABBV-2222

In this study, participants will be given ABBV-3067 (“potentiator”) and ABBV-2222 (“corrector”) to see if treatment improves participants’ lung function. Different groups of participants will receive different doses, and some will receive a dummy drug (“placebo”). This study evaluates the safety and efficacy (how well the medications work) of the medications and the best dose of each medicine to be used in future studies. This is a Phase 2, double-blinded (treatment type is unknown to participants and investigators) study in people with CF who have two copies of the F508del mutation (the most common CFTR gene mutation). Participants go through a screening process (up to a month) and receive study treatment for up to a month, followed by a review, a month later. Tests done for the study include lung function tests, sweat chloride tests, blood and urine tests, and ECG. Side effects are monitored through the course of the study.

A study to learn more about a combination of CFTR modulator medicines in people with Cystic Fibrosis

This study is being done to learn more about a new medication called ‘VX-445’ when taken in combination with tezacaftor and ivacaftor. All three of these medications are known as CFTR modulators. CFTR modulators work to treat the underlying genetic cause of cystic fibrosis. This combination of medication is being assessed in people with Cystic Fibrosis who are 12 years and older and who are homozygous for the F508del mutation. The study will investigate how well these medications work and to check that they are safe to use. It is the hope that this combination of medications will have positive effects in some people with Cystic Fibrosis. Participants will be asked to come into the clinic at the recruitment centre 7-8 times over a 5 month period where study assessments will take place (blood tests, questionnaires, lung function etc.).

A study of 2 CFTR modulators in people with cystic fibrosis (FDL169 & FDL176)

In this study investigational CFTR modulators called FDL169 and FDL176 will be studied when given in combination. FDL169 is an oral medication that improves the function of the protein that is defective in Cystic Fibrosis (the CFTR protein), a type of compound known as a CFTR corrector. FDL169 is planned as a long-term treatment of CF in people who have the genetic mutation known as F508del-CFTR mutation. FDL176 is an oral medication that aims to improve the function of the protein that is defective in Cystic Fibrosis (CF) (the CFTR protein), a type of compound known as a CFTR potentiator. The aim of this trial is to study how well FDL169 and FDL176 are tolerated by people with CF when given in combination. In addition, the trial will study how the medications move around the body, and how they are absorbed and digested. For this purpose, the amount of FDL169 and FDL176 will be measured in your blood at specific intervals after you take the tablet orally (this is called pharmacokinetics [PK]). The impact on your CF will also be measured with tests for sweat chloride and changes in lung volumes, measured by spirometry tests.

Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor

This study will look at whether two drugs (called lumacaftor and ivacaftor) can help treat cystic fibrosis when taken together over a long period of time. It will also look at whether they are safe over this period. You can only take part in this study if you took part in a study called VX14-809-109, and if you meet certain criteria. These criteria will be checked by the study doctor and nurse at a screening visit. If you meet these criteria you will be treated with lumacaftor and ivacaftor together for approximately 96 weeks. A follow up visit will be held 28 days after the last dose of lumacaftor and ivacaftor. You will need to attend the clinic for 15 visits over the study duration and will undergo a range of tests. Participants who stopped taking the study drugs early in the VX14-809-109 study will be invited to take part in an observational study. They will not receive the study drug but will receive regular phone calls.