CFF provided information on the following clinical trial:
11/10/2015 – Phase 2 safety study of N91115 in adults with CF with two copies of the F508del-CFTR gene mutation who are currently taking ivacaftor/lumicaftor (Orkambi)
This is a phase 2 placebo controlled trial that will look at the safety and effectiveness of the drug N91115. This trial will also look at how the body processes the drug.
Researchers will test the drug in people with cystic fibrosis who have two copies of the F508del-CFTR mutation and are taking Orkambi. In this trial researches are aiming to show an improvement in lung function as well as other health outcomes. They will also monitor the how the body processes the drug and the drug’s safety. This trial will require blood draws, lung function tests, and sweat tests. It will last 16 weeks and is for people who are over the age of 18.
- CFF Link: https://tools.cff.org/Display/dsp_ClinicalResearchHTML.cfm?id=421&CTSubId=127
- ClinicalTrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT02589236