MACARONI-23 -Study B

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23Pathway to Establish Efficacy in Pediatric Crohn’s Disease (MACARONI-23) -Study B

• IRAS ID

  1007171

• Contact name

  Harald Tietz

• Contact email

  Tietz_Harald@Lilly.com

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2022-000811-29

• Clinicaltrials.gov Identifier

  NCT05509777

• Research summary

  Crohn’s disease is a long-term condition that causes redness, swelling (inflammation), and sores along the digestive tract. Current medications may help improve symptoms of CD in some patients, but not in others.

  The purpose of the MACARONI-23 study is to see whether two investigational study drugs, mirikizumab and guselkumab, each designed by a different sponsor, work in paediatric patients with Crohn’s disease, how safe they are in terms of side effects, and how the body handles taking them. Because the 2 study drugs are very similar in their makeup and what they are designed to do in the body, the Sponsors have decided to work together on this study.

  Participants who:
  • are aged 2 to 17 years old,
  • have been diagnosed with moderate to severe CD,
  • do not have well-controlled CD,
  • and meet all the eligibility criteria
  will be enrolled into the study by consenting themselves or through their parents.

  The total study duration for each participant will be up to 74 weeks as follows:
  • Screening period (lasting up to 6 weeks)
  • Induction period (lasting 12 weeks)
  • Maintenance period (lasting 40 weeks)
  • Safety follow-up period (lasting up to 16 weeks)

  In this particular arm of the study, around 90 participants will be randomly assigned (like flipping a coin) to receive mirikizumab. In the induction period all participants will get mirikizumab; sent into the vein using a needle that is inserted in a vein. In the maintenance period the study drug will be given to participants by subcutaneous injection. Participants who are benefitting from the study drug, as defined by their study doctor, will be able to receive continued treatment via a long-term extension study.

• REC name

  West of Scotland REC 1

• REC reference

  23/WS/0019

• Date of REC Opinion

  9 Feb 2024

• REC opinion

  Further Information Favourable Opinion