TRIAL EVALUATING EFFICACY AND SAFETY OF HYDROXYCHLOROQUINE VERSUS PLACEBO IN EARLY SYSTEMIC SCLEROSIS (SSc)

Prior treatment

• Known hypersensytivity to the study drug (active substance or excipients) or derivatives 4-aminoquinolines
• Anticoagulant and/or antiplatelet therapy

Other illness

• History of retynopathy and/or maculopathy
• History of severe miopathy (other than SSc related)
• History of periferic neuropathy
• History of hypoglycemia
• History of bradycardia (HR<50) or ventricular arrhythmias

Lab values

• Deficiency of glucose-6-phosphate dehydrogenase
• Other contraindicated clinical and / or laboratory conditions

Age

• Age < 18 years

Other

• Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1
• Pregnant or breast feeding women
• Body weight < 45 kg

• Diagnosis of SSc according 2013 ACR/EULAR criteria for classification of SSc (van den Hoogen et al, 2013).
• Written Informed Consent (IC)(patient must be able and agree to sign an IC according ICH-GCP guidelines and local laws)
• Age >= 18 years
• Disease duration <= 5 years from the first non-Raynaud’s symptom
• Stable SSc standard treatment within 4 weeks prior to Screening visit
• Subjects naïve to treatment with hydroxychloroquine or who have undergone a wash-out period of at least 16 weeks (approximately 3 half-lives of the drug)