Due to the COVID-19 pandemic and consideration of the risk of severe adverse outcomes associated with COVID-19 among patients with respiratory and autoimmune diseases, and on recommendation from the parent study’s DSMB (402-C-1504), the Sponsor decided to stop the Phase 3 Study (1504) in patients with CTD-PAH. Patients with CTD-PAH have compromised cardiopulmonary function, are often receiving immunosuppressants, and are at an inherently high risk of adverse outcomes in the event of infection. The Sponsor concluded that continued exposure of these high-risk patients to clinic or in-person visits presented an unacceptable risk. The 1504 parent study was not stopped as a result of any bardoxolone methyl-related safety concern, and the DSMB did not reported any treatment-related safety concerns. There were no deaths in the bardoxolone methyl arm of study 1504, and fewer patients reported serious adverse events (SAE) in the bardoxolone methyl arm compared to the placebo arm within the 1504 study. While no futility analyses were performed, an initial review of available efficacy data provided by the DSMB suggested that Study 1504 was unlikely to meet the primary endpoint of improvement in 6MWD compared to placebo at Week 24. Concomitant with the decision to close Study 1504, the Sponsor also closed Study this study 402-C-1602.