Efficacy of Pomalidomide in Systemic Sclerosis (SSC), amend.1 08NOV11

• Research type

  Research Study

• Full title

  A Phase 2, Proof-of-Concept, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) In Subjects with Diffuse Cutaneous Systemic Sclerosis with Interstitial Lung Disease

• IRAS ID

  92593

• Contact name

  Paul Emery

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2010-023047-15

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of this study is to evaluate whether an unlicenced drug called pomalidomide is safe and effective compared to placebo (??dummy pill?) in treating subjects with a condition called diffuse cutaneous systemic sclerosis (dc-SSc). Subjects in this study are also required to have lung disease related to their dc-SSc. Approximately 88 subjects will be enrolled worldwide in this study. Participating countries include the United States, United Kingdom, Italy, Switzerland, Germany, Poland, Australia, France, Sweden, and Spain. The length of study participation for each subject is up to 5 years and 9 weeks. Subject participation consists of 4 phases: ?½ Pre-treatment Screening Phase: up to 5 weeks prior to the start of study drug ?½ Treatment Phase: 52 weeks ?½ Observation Phase: 4 weeks post-treatment ?½ Long-term Follow-up Phase: Up to 5 years from treatment initiation Subjects will have regularly scheduled visits (weekly for the first month, every 2 weeks for the next 2 months and monthly thereafter) to assess study drug activity. During the Long-term Follow-up Phase, subjects will be contacted two times per year by phone.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  12/YH/0011

• Date of REC Opinion

  8 Mar 2012

• REC opinion

  Further Information Favourable Opinion