SHP647 as an induction therapy for moderate to severe Crohn's disease

• Research type

  Research Study

• Full title

  A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305)

• IRAS ID

  243672

• Contact name

  Matthew Brookes

• Contact email

  matthew.brookes@nhs.net

• Sponsor organisation

  Shire Human Genetic Therapies, Inc.

• Eudract number

  2017-000575-88

• Clinicaltrials.gov Identifier

  NCT03559517

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  Crohn’s Disease (CD) is a chronic, reoccurring disease that causes inflammation of the gut. The most common symptoms are abdominal (stomach) pain, diarrhoea and rectal bleeding. Standard treatments for CD include aminosalicylates, glucocorticoids, immunosuppressants, opiates and biologics.

  SHP647 binds to certain proteins in the gut to lessen inflammation. The aim of this study is to see if SHP647 is safe and can lessen CD symptoms.
  To take part in this study, participants must be between 16- 80 years old, have moderate to severe CD and have not responded well to standard treatments.

  SHP647 will be given by injection under the skin.

  Participants will get 1 of 3 treatments by chance (like rolling dice) of one of the following:
  • SHP647 dose of 25 mg in 1 ml of liquid
  • SHP647 dose of 75 mg in 1 ml of liquid
  • Placebo (looks like SHP647 but with no medicine in it).

  CD disease activity will be checked using the ‘Crohn’s disease activity index’ and with biopsy results. Participants will be in remission if both the CD symptoms and endoscopy results improve up to a certain amount.

  Participant safety will be checked by looking at side effects from study participation and from SHP647 and placebo.

  One blood sample from each participant will be banked. This may be tested if the participant shows signs of certain symptoms related to brain function.
  About 1032 participants are planned to enrol in this study, with ~15 of them enrolling in the UK.

  Each participant will make at least 7 study visits to the clinic over ~5 months. Each participant will continue into a 4month safety follow-up period if they either discontinue treatment early or complete the treatment period and do not enter the maintenance study or long-term safety extension study.

  Shire is the sponsor of this study.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  18/SC/0431

• Date of REC Opinion

  28 Feb 2019

• REC opinion

  Further Information Favourable Opinion