NCT04744207

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

A Phase II, Randomized, Multi-center, Placebo-controlled, Double-blind Study to Investigate the Safety of GS-248, and Efficacy on Raynaud's Phenomenon (RP) and Peripheral Vascular Blood Flow, in Subjects With Systemic Sclerosis (SSc)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Gesynta Pharma AB · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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). This is a randomized, double-blind, placebo-controlled study conducted in multiple sites in 4 countries in Europe. Approximately 80 subjects will be randomized in a 1:1 allocation to receive either GS-248 (120 mg) or placebo once daily. The study will comprise an enrolment period, a treatment period, and a follow-up period, with a total of 5 study visits over approximately 10 weeks.

Conditions

• Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	GS-248	120 mg, capsule, once daily for 4 weeks
DRUG	Placebo	capsule, once daily for 4 weeks

Timeline

• Start date: 2020-12-29
• Primary completion: 2022-06-15
• Completion: 2022-06-15
• First posted: 2021-02-08
• Last updated: 2024-08-09
• Results posted: 2024-08-09

Locations

12 sites across 4 countries: Belgium, Netherlands, Poland, United Kingdom