Selonsertib in Adults With Pulmonary Arterial Hypertension

Summary

The primary objective of this study is to evaluate the effect of selonsertib (GS-4997) on pulmonary vascular resistance (PVR), as measured by right heart catheterization (RHC) in adults with pulmonary arterial hypertension (PAH). The study will consist of a 24-week placebo-controlled treatment period and a long-term selonsertib treatment period. Participants completing the 24-week placebo-controlled period will be eligible to receive active treatment with selonsertib in the long-term treatment period.

Timeline

Start

2014-11

Primary completion

2016-04

Completion

2016-12

Outcome

Missed primary endpoint

paper Selonsertib once daily for 24 weeks did not lead to a significant reduction in pulmonary vascular resistance PMID 34425071 ↗

registry Selonsertib 2 mg vs Placebo; p = 0.214 NCT02234141 ↗

registry Selonsertib 6 mg vs Placebo; p = 0.270 NCT02234141 ↗

registry Selonsertib 18 mg vs Placebo; p = 0.604 NCT02234141 ↗

release “Separately, a Phase 2 study of GS-4997 in PAH did not achieve its primary endpoint” gilead.com ↗

Publications

• Rosenkranz S, Feldman J, McLaughlin VV, Rischard F, Lange TJ, White RJ, Peacock AJ, Gerhardt F, Ebrahimi R, Brooks G, Satler C, Frantz RP; ARROW Study Group. Selonsertib in adults with pulmonary arterial hypertension (ARROW): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Respir Med. 2022 Jan;10(1):35-46. doi: 10.1016/S2213-2600(21)00032-1. Epub 2021 Aug 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Selonsertib	Small molecule	2 mg	Oral
Subject	Selonsertib	Small molecule	6 mg	Oral
Subject	Selonsertib	Small molecule	18 mg	Oral

Indications