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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
94
Investigator site
Ghent, Belgium
Investigator Site
Nijmegen, Netherlands
Investigator site
Gdansk, Poland
Investigator Site
Krakow, Poland
Mean Change From Baseline to Week 4 in the Number of Raynaud Attacks Per Week.
Patient reported number of Raynaud's attacks per day as registered in electronic diary.
Time frame: From baseline to week 4, i.e. the 7 most recent days prior to Visit 2 and Visit 4 respectively
Mean Change From Baseline to Week 4 in the Raynaud's Condition Score.
Patients reported Raynaud's Condition Score (RCS) once a day in an electronic diary. RCS is a validated numeric rating scale (from 0 to 10) answering the question "What difficulty did you have today with your Raynaud's condition?" where a score of '0' = 'No difficulty', and a score of '10' = 'Extreme difficulty'.
Time frame: From baseline to week 4, i.e. the 7 most recent days prior to Visit 2 and Visit 4 respectively
Mean Change From Baseline to Week 4 in Pain Experienced During Raynaud Attacks.
The patient reported the experienced pain of each Raynaud attack using a Numeric Rating Scale (NRS) from 0 to 10 in an electronic diary where '0'='No pain' and '10'='Worst imaginable pain'.
Time frame: From baseline to week 4, i.e. the 7 most recent days prior to Visit 2 and Visit 4 respectively
Mean Change From Baseline to Week 4 in the Mean Duration of Raynaud's Attacks
The patient reported the start time (hh:mm) and stop time (hh:mm) of each Raynaud's attack in the electronic diary.
Time frame: From baseline to week 4, i.e. the 7 most recent days prior to Visit 2 and Visit 4 respectively
Mean Change From Baseline to Week 4 in the Cumulative Duration of Raynaud Attacks.
The patient reported the start time (hh:mm) and stop time (hh:mm) of each Raynaud's attack in the electronic diary.
Time frame: From baseline to week 4, i.e. the 7 most recent days prior to Visit 2 and Visit 4 respectively
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Investigator site
Lublin, Poland
Investigator site
Bath, United Kingdom
Investigator site
Cambridge, United Kingdom
Investigator Site
Dundee, United Kingdom
Investigator site
Leeds, United Kingdom
Investigator Site
Liverpool, United Kingdom
...and 2 more locations