JBT101-SSc-002 Efficacy & Safety Study of Lenabasum in SSc

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

• IRAS ID

  231258

• Contact name

  Christopher Denton

• Contact email

  c.denton@ucl.ac.uk

• Sponsor organisation

  Corbus Pharmaceuticals, Inc.

• Eudract number

  2017-000372-29

• Clinicaltrials.gov Identifier

  116313, Investigational New Drug number; DERM 35490 , NIHR CRN - CPMS ID; MUSC 35490, NIHR CRN - CPMS ID

• Duration of Study in the UK

  2 years, 5 months, 0 days

• Research summary

  This is a 52 week double-blind multi-center study to evaluate potential efficacy of lenabasum in subjects with diffuse cutaneous systemic sclerosis (SSc) worldwide. This study will also investigate the safety and tolerability of the lenabasum in SSc subjects. Approximately 354 subjects will be enrolled in this study. Enrolled subjects will be randomly assigned to one of three treatment groups; 5 mg twice a day, 20 mg twice a day or placebo twice a day respectively.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  18/EE/0023

• Date of REC Opinion

  20 Mar 2018

• REC opinion

  Further Information Favourable Opinion