Armata Pharmaceuticals, Inc. (Armata) has begun a study of an investigational drug (also known as the "study drug") called AP-PA02 as a possible treatment for individuals with cystic fibrosis (CF) and chronic pulmonary Pseudomonas aeruginosa (Pa) infection. The main purposes of this study are to learn about how safe and how well tolerated the study drug is compared to the placebo. This study has two parts, Part 1 and Part 2. You may only participate in Part 1 or Part 2, not both. If you participate in Part 1 of the study, the screening period is up to 21 days, and the on-study period is 29 days, for a total of up to 50 days, and you will need to come to the study center 8 times over this study period. If you are in Part 2 of the study, the screening period is up to 21 days, and the on-study period is 31 days, for a total of up to 52 days, and you will need to come to the study center 10 times over this study period. This study will take place in approximately 12 centers in the United States with about 48 people with CF and chronic Pa participating.
The SIMPLIFY study is being done to test whether or not it is safe to stop taking inhaled hypertonic saline or Pulmozyme® (dornase alfa) in those people that are also taking Trikafta™. The SIMPLIFY studyl consists of two similar studies conducted within the same protocol that are being done to answer the following questions:
• Study A: For people with CF taking Trikafta, does stopping treatment with hypertonic saline (at least 3%) have a similar effect on lung function as continuing treatment with hypertonic saline?
• Study B: For people with CF taking Trikafta, does stopping treatment with Pulmozyme have a similar effect on lung function as continuing treatment with Pulmozyme?
There are a total of 4 study visits (a screening visit and three additional visits during the active part of the study). There is a 2-week screening period and a 6-week active study period.About 920 people with CF who are 12 years of age or older will take part in this study at approximately 80 hospitals and clinics around the country. Of this total, approximately 520 people will participate in the hypertonic saline (Study A) portion and 400 people with participate in the Pulmozyme (Study B) portion of the study.