Ustekinumab for Pediatric Crohn's Disease
(UNITI Jr Trial)

Recruiting in Palo Alto (17 mi)

+70 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing a medication that reduces inflammation in children with severe Crohn's disease. The goal is to see if it can help them get better and stay better. The study will also check how safe the medication is and how it works in the body.

Eligibility Criteria

This trial is for children with moderately to severely active Crohn's disease, confirmed by endoscopy and histology. They must have a PCDAI score >30 and show ulceration or elevated CRP/fecal calprotectin levels. Girls who can have babies must test negative for pregnancy. Kids with certain infections, recent investigational drug use, Crohn's complications that might need surgery, cancer history, or serious organ problems can't join.

Inclusion Criteria

I am a woman who can have children and have tested negative for pregnancy.

I have Crohn's disease with active inflammation, confirmed by a past endoscopy.

I have active Crohn's disease with a recent test showing ulcers in my intestines.

+1 more

Exclusion Criteria

I do not have severe ongoing issues with my liver, kidneys, heart, lungs, or other major systems.

I have or had cancer or symptoms that might suggest blood cancer.

I have had infections like histoplasmosis or similar conditions before.

+2 more

Participant Groups

The study tests Ustekinumab in kids to see if it helps them reach and maintain remission from Crohn's symptoms compared to a placebo (a treatment with no active drug). It also looks at the safety of the drug and how it moves through and out of their bodies over time.

3Treatment groups

Experimental Treatment

Group I: Ustekinumab Subcutaneous (SC) Every 8 Weeks (q8w): Maintenance PeriodExperimental Treatment2 Interventions

Participants will receive SC administration of ustekinumab q8w based on BSA (mg/m\^2) or weight-tiered induction dose (mg/kg) at maintenance weeks (Weeks M)-0, M-8, M-16, M-24, M 32, and M-40 and matching placebo at Weeks M-12 and M-36 to maintain the blind.

Group II: Ustekinumab SC Every 12 Weeks (q12w): Maintenance PeriodExperimental Treatment2 Interventions

Participants will receive SC administration of ustekinumab q12w based on BSA (mg/m\^2) or weight-tiered induction dose (mg/kg) at Weeks M-0, M-12, M-24, M-36 and matching placebo at Weeks M-8, M-16, M-32, and M-40 to maintain the blind.

Group III: Open- Label Ustekinumab Intravenous (IV): Induction PeriodExperimental Treatment1 Intervention

All participants will receive a single IV administration of ustekinumab at induction Week 0 (I-0) based on body surface area (BSA) (milligram per meter square \[mg/m\^2\]) or weight-tiered induction dose (milligram per kilogram \[mg/kg\]).

Ustekinumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Stelara for: