MACARONI-23 -Study A
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn’s Disease. -Study A
IRAS ID
1007170
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2021-006282-37
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, guselkumab and mirikizumab, 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, up to 120 participants will be randomly assigned (like flipping a coin) to receive guselkumab. In the induction period all participants will get guselkumab; sent into the vein using a needle or given in an injection. In the maintenance period participants will have a 50% chance to receive either guselkumab or placebo, via injection only. Placebo looks like the study drug but contains no active medication. It’s used to help determine if results are due to the study drug or something else. Participants who are benefitting from the study drug will be able to receive continued treatment via a long-term extension study.
REC name
West of Scotland REC 1
REC reference
23/WS/0018
Date of REC Opinion
16 Feb 2024
REC opinion
Further Information Favourable Opinion