ACT12339 - SAR100842 in Diffuse Cutaneous Systemic Sclerosis

• Research type

  Research Study

• Full title

  Double-Blind, Randomized, Placebo-Controlled, 8-Week Study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis.

• IRAS ID

  108844

• Contact name

  Christoper Denton

• Sponsor organisation

  Sanofi

• Eudract number

  2012-001369-34

• ISRCTN Number

  N/A

• Research summary

  This is a multicenter study being conducted in North America and Europe in 15 planned sites. Approximately 30 patients with diffuse cutaneous systemic scleroderma will be enrolled of which approximately 15 will receive SAR100842 and approximately 15 will receive matching placebo. Scleroderma is a connective tissue disease that affects the skin and other major internal organs. Excess collagen is laid down in these organs which in turn results in scarring and reduced normal function of the affected organs. In the condition being studied here the skin involvement includes the fingers, hands, forearms, lower legs, face, chest wall and other areas of the body. Patients enrolling in this study must meet certain requirements, which will be checked during a 2 week screening period. If the patient is suitable, the total study period will be approximately 13 weeks including approximately 8 weeks of the study drug SAR100842 or matching placebo, followed by 3 weeks without drug to follow the patients clinical condition. The study involves 6 planned visits to the study site and 2 further telephone calls to see how patients are doing at pre-scheduled designated timelines. Participants in this current study will be randomly assigned to receive either 300 mg twice daily of SAR100842 or matching placebo. The treatment is taken orally (by mouth) for 8 weeks. Two pills; one of a 100 mg and one of 200 mg (slightly larger) will be taken every morning and every evening (total of 4 pills every day). The study is a double-blind meaning that no one will know who is receiving SAR100842 or placebo. The purpose of this study is to evaluate the possible risks, the effectiveness, and certain characteristics of SAR100842 such as what the medication does to the body and what the body does to the medication.

• REC name

  London - South East Research Ethics Committee

• REC reference

  12/LO/1297

• Date of REC Opinion

  26 Oct 2012

• REC opinion

  Further Information Favourable Opinion