A Phase 2 Study of RSLV-132 in Subjects with Sjogren's Syndrome

• Research type

  Research Study

• Full title

  A Phase 2, Double-Blind, Placebo-Controlled Study of RSLV-132 in Subjects with Primary Sjogren’s Syndrome

• IRAS ID

  211563

• Contact name

  Wan-Fai Ng

• Contact email

  wan-fai.ng@newcastle.ac.uk

• Sponsor organisation

  Resolve Therapeutics LLP

• Eudract number

  2016-001586-87

• Duration of Study in the UK

  1 years, 9 months, 8 days

• Research summary

  RSLV-132 is a new drug being developed for the treatment of autoimmune diseases. An autoimmune disease develops when the immune system decides that healthy cells are in fact foreign and attacks them. Primary Sjogren’s syndrome (pSS) is an autoimmune disease characterized by dry eyes and dry mouth due to long-term inflammation which damages tear ducts and salivary glands. Research has shown that the immune system of patients with pSS often reacts against their own proteins to form something called “immune complexes”. These immune complexes are believed to trigger inflammation and worsen the disease. RSLV-132 is designed to break up these immune complexes and remove them from the body. The purposes of this study are:
  • To determine if RSLV-132 is safe and well tolerated in pSS
  • To see if RSLV-132 reduces the abnormal immune response related to pSS
  • To determine whether RSLV-132 decreases disease severity in pSS
  • To determine whether RSLV-132 decreases fatigue in pSS

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  16/NE/0321

• Date of REC Opinion

  29 Sep 2016

• REC opinion

  Favourable Opinion