Ustekinumab for Ulcerative Colitis
(UNIFI Jr Trial)

Recruiting in Palo Alto (17 mi)

+81 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?

The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active UC.

Eligibility Criteria

This trial is for children with moderate to severe Ulcerative Colitis (UC). They must have a confirmed diagnosis of UC, a Mayo score of 6-12, and an endoscopy subscore >=2. Girls who can have babies need a negative pregnancy test. Kids can't join if they only have rectal UC, recent bowel blockages, certain infections like TB or fungal diseases, any cancer history, or allergies to ustekinumab.

Inclusion Criteria

Medically stable on the basis of physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator

My ulcerative colitis is moderate to severe, with a Mayo score of 6-12.

I was diagnosed with ulcerative colitis before screening.

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Exclusion Criteria

I have had infections like histoplasmosis or similar conditions before.

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

My ulcerative colitis affects only my rectum or less than 20 cm of my colon.

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Treatment Details

Interventions

Ustekinumab (Monoclonal Antibodies)

Trial OverviewThe study tests Ustekinumab's effectiveness in causing remission in kids with UC and checks its safety and how the body processes it. Participants will either receive Ustekinumab doses based on their size or a placebo without knowing which one they're getting.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Maintenance (M) Period: Ustekinumab once every 8 Week (q8w)Experimental Treatment2 Interventions

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

Group II: Maintenance (M) Period: Ustekinumab once every 12 Week (q12w)Experimental Treatment2 Interventions

Participants will receive SC administration of ustekinumab every 12 weeks (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: Induction Period (I): UstekinumabExperimental Treatment1 Intervention

All participants will receive a single intravenous (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: