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

NCT04744207 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2024-08-09

Study results available
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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).

Conditions

Interventions

DRUG

GS-248

120 mg, capsule, once daily for 4 weeks

DRUG

Placebo

capsule, once daily for 4 weeks

Sponsors & Collaborators

  • Ergomed

    collaborator INDUSTRY

  • Gesynta Pharma AB

    lead INDUSTRY

Principal Investigators

  • Charlotte Edenius · Gesynta Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-29
Primary Completion
2022-06-15
Completion
2022-06-15

Countries

  • Belgium
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04744207 on ClinicalTrials.gov