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

Clinical Trial Details

The purpose of this clinical research study is to see whether 2 investigational study drugs, Guselkumab and Mirikizumab, work in patients with Crohn’s disease (CD) who are 2 to 17 years of age at the time of joining the study.

Investigational means that these drugs are not approved by the U.S. Food and Drug Administration (FDA).

Participants will be randomized into one or two study groups. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group. One group will receive Guselkumab and the other will receive Mirikizumab.

Both Guselkumab and Mirikizumab may be administered via an intravenous (IV) infusion or subcutaneous (SC) injection.

Study participants will visit the study center for study procedures every 4 weeks and they will receive the study drug for 48 weeks. Participants will also be asked to take part in tests and assessments.

Total study participation will last over a year (up to 74 weeks, which is about 17 months).

Key Eligibility:

2 to 17 years of age
Have a diagnosis of Crohn's Disease (CD) or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria. Diagnosis based on prior surgical resection and histology is also acceptable. Radiographic findings may provide supportive evidence.

Detailed eligibility will be reviewed when you contact the study team.

Return to List

Study contact by location

Upper East Side - Manhattan

Contact(s)

Olivia Ketcham
olk4007@med.cornell.edu

Primary Investigator(s)

Aliza B Solomon, DO

Protocol ID(s)

Weill Cornell Medicine IRB #:

2310026662

ClinicalTrials.gov:

Janssen - EudraCT NUMBER: 2021-006282-37; Lilly - EudraCT: 2022-000811-29

Status

Open to Enrollment

Age Group

Pediatric

Disease

Crohn's Disease