A Phase 2 multiple dose trial of NNC109-0012 (Anti-IL-20) in RA.

• Research type

  Research Study

• Full title

  A Phase 2 randomised, double blind, placebo controlled, multiple dose trial of NNC109-0012 (Anti-IL-20) in subjects with rheumatoid arthritis.

• IRAS ID

  59829

• Contact name

  Andrew Ostor

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2010-021283-14

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a Phase 2, randomised, double blind, placebo-controlled multiple dose trial of NNC109-0012 (Anti-IL20) intending to assess the efficacy in subjects with rheumatoid arthritis. The trial will consist of one cohort with 44 subjects randomised to active treatment with NNC109-0012 and 22 subjects randomised to placebo. The subjects will each receive 12 weekly doses of NNC109-0012 3mg/kg level with a follow up period for an additional 15 weeks (a total of 27 weeks). The dose selected is based on blinded safety and PK data from the current ongoing multiple dose phase 1 (NN8226-3704) in subjects with active RA.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  10/H0308/102

• Date of REC Opinion

  14 Jan 2011

• REC opinion

  Further Information Favourable Opinion