Boehringer Ingelheim announced the initiation of trial 1199.222, a new 12-week study to assess the safety, tolerability and pharmacokinetics of add-on treatment with pirfenidone to background therapy with Ofev in patients with idiopathic pulmonary fibrosis (IPF).
The trial’s primary endpoint is the percentage of patients with on-treatment gastrointestinal (GI) adverse events from baseline to week. Pirfenidone was approved in 2014. Pirfenidone is frequently associated with gastrointestinal side effects such as dyspepsia, nausea, gastritis, gastroesophageal reflux disease and vomiting. On October, the FDA approved
Ofev for IPF with side effects including diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, decreased weight, and high blood pressure.
What is Idiopathic Pulmonary Fibrosis?
IPF is a disease in which tissue in the lungs becomes thick and stiff, or scarred, over time. Symptoms include breathlessness, chronic cough, chest pain, weight loss and low energy.
IPF affects about 128,100 people in the United States, with about 48,000 new cases diagnosed annually.
The study is enrolling approximately 100 patients. The primary endpoint is percentage of patients with on-treatment gastrointestinal adverse events from baseline to week 12, as the most frequent adverse events for both products are of gastrointestinal nature. On-treatment adverse events are defined as AEs with an onset from the first dose of randomized treatment up to the last dose of randomized treatment (inclusive).
As a secondary endpoint, the amount of OFEV and pirfenidone circulating in the blood will be measured during the trial in order to assess if pirfenidone interacts with OFEV and influences the amount found in the blood.
Eligible participants will be randomized to receive OFEV 150 mg twice daily or OFEV 150 mg twice daily combined with pirfenidone (titrated up to a dose of 801 mg three times daily). Randomized treatment will last 12 weeks. During the randomized treatment period, dose reductions and/or temporary interruptions are allowed for both drugs in case of adverse effects.
“The safety and wellbeing of patients is at the center of everything we do,” said Christopher Corsico MD, corporate senior vice president medicine and chief medical officer of Boehringer Ingelheim. “We are initiating this trial to ensure that we provide the scientific community with important information regarding OFEV combination therapy. This trial is part of our continued commitment to tackling the global burden of progressive fibrotic lung diseases.”
Initiation of first multinational study to evaluate safety of OFEV® (nintedanib) with add-on of pirfenidone in patients with IPF [news release]. Ingelheim, Germany; Boehringer Ingelheim: December14, 2015. http://www.businesswire.com/news/home/20151214005474/en/Initiation-multinational-study-evaluate-safety-OFEV®-nintedanib