A Study to Investigate Safety of GS-248 and Efficacy on Raynauds' Phenomenon in Systemic Sclerosis

Summary

The primary objective of this study is to determine the safety, and evaluate the efficacy of GS-248 versus placebo on Raynaud's Phenomenon (RP) in subjects with Systemic Sclerosis (SSc).

Timeline

Start

2020-12-29

Primary completion

2022-06-15

Completion

2022-06-15

Outcome

Missed primary endpoint

registry analysis (superiority test); GS-248 vs Placebo; p <0.05; Least squares mean estimate 0.81 (95% CI -2.48 to 4.10); ANCOVA NCT04744207 ↗

release “No significant effects were seen after treatment with GS-248 compared to placebo in terms of symptomatic relief in patients with systemic sclerosis.” gesynta.se ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vipoglanstat	Small molecule	120 mg	—

Indications