Ziritaxestat, a Novel Autotaxin Inhibitor, and Lung Function in Idiopathic Pulmonary Fibrosis: The ISABELA 1 and 2 Randomized Clinical Trials.

ABSTRACT:

Importance

There is a major need for effective, well-tolerated treatments for idiopathic pulmonary fibrosis (IPF).

Objective

To assess the efficacy and safety of the autotaxin inhibitor ziritaxestat in patients with IPF.

Design, setting, and participants

The 2 identically designed, phase 3, randomized clinical trials, ISABELA 1 and ISABELA 2, were conducted in Africa, Asia-Pacific region, Europe, Latin America, the Middle East, and North America (26 countries). A total of 1306 patients with IPF were randomized (525 patients at 106 sites in ISABELA 1 and 781 patients at 121 sites in ISABELA 2). Enrollment began in November 2018 in both trials and follow-up was completed early due to study termination on April 12, 2021, for ISABELA 1 and on March 30, 2021, for ISABELA 2

SUBMITTER: Maher TM 

PROVIDER: S-EPMC10170340 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature