SuMILE Trial

Uses

Benefits

Other

Highlighted claims

• The SuMILE trial evaluates sotatercept add-on therapy against vasodilator-based standard care alone in adults with PAH due to unrepaired ASD, VSD, or PDA. — Protocol for an open-label, randomised, controlled trial to evaluate the efficacy and safety of sotatercept add-on therapy compared with pulmonary vasodilator-based standard of care for pulmonary vasodilator-resistant pulmonary arterial hypertension associated with unrepaired congenital shunts (atri
• The trial hypothesis is that sotatercept will improve 6-minute walk distance at 24 weeks. — Protocol for an open-label, randomised, controlled trial to evaluate the efficacy and safety of sotatercept add-on therapy compared with pulmonary vasodilator-based standard of care for pulmonary vasodilator-resistant pulmonary arterial hypertension associated with unrepaired congenital shunts (atri
• The trial protocol also seeks to characterise safety, feasibility, blood count dynamics, dose exposure, adverse events, and conditions for safe use. — Protocol for an open-label, randomised, controlled trial to evaluate the efficacy and safety of sotatercept add-on therapy compared with pulmonary vasodilator-based standard of care for pulmonary vasodilator-resistant pulmonary arterial hypertension associated with unrepaired congenital shunts (atri
• The open-label design was chosen to prioritise safety and collect detailed safety information in a population excluded from pivotal sotatercept trials. — Protocol for an open-label, randomised, controlled trial to evaluate the efficacy and safety of sotatercept add-on therapy compared with pulmonary vasodilator-based standard of care for pulmonary vasodilator-resistant pulmonary arterial hypertension associated with unrepaired congenital shunts (atri