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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Subjects must provide signed and dated written informed consent before the conduct of any study-specific procedures.
* Male and female subjects aged 18-75 years inclusive.
* Systemic Sclerosis diagnosed according to European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria (van den Hoogen F et al. 2013). Subjects with signs of other autoimmune diseases (e.g. Sjögren's syndrome, myositis, rheumatoid arthritis) could be included if SSc is the dominating phenotype.
* Raynaud attacks typically ≥7 times per week during the last 4 weeks prior to screening despite background medication (only allowed vasodilatory therapy is calcium channel blockers or PDE-5 inhibitors).
* Women of childbearing potential must be using a highly effective method of contraception to avoid pregnancy throughout the study and for 4 weeks after the last dose of Investigational Medicinal Product in such manner that the risk of pregnancy is minimised.
* Women must not be pregnant or breastfeeding.
* Male subjects to agree to use condom in combination with use of contraceptive methods with a failure rate of \<1% to prevent pregnancy and drug exposure of a partner, and refrain from donating sperm from the first date of dosing until 3 months after last dosing of the IMP.
* Ability of subjects to participate fully in all aspects of this clinical trial.
Exclusion Criteria:
* Systemic Sclerosis disease duration of greater than 120 months from first non-Raynau…
What they're measuring
1
Mean Change From Baseline to Week 4 in the Number of Raynaud Attacks Per Week.
Timeframe: From baseline to week 4, i.e. the 7 most recent days prior to Visit 2 and Visit 4 respectively