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Monoclonal Antibodies

Ustekinumab for Ulcerative Colitis (UNIFI Jr Trial)

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with a screening Mayo endoscopy subscore >= 2 as determined by a central review of the video of the endoscopy

Must have had UC diagnosed prior to screening

Must not have

Have a history of latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to screening

Presence or history of any malignancy including presence or history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (example, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas) and monoclonal gammopathy of undetermined significance, or clinically significant hepatomegaly or splenomegaly

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 74 weeks

Awards & highlights

Pivotal Trial

Summary

This trial will study whether ustekinumab is effective and safe for treating children with ulcerative colitis, as well as how the body processes the drug.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Ustekinumab may cause immune system problems leading to serious infections, allergic reactions including rash and difficulty breathing, potential liver issues indicated by yellowing skin/eyes or dark urine, and possibly headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I was diagnosed with ulcerative colitis before screening.

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My ulcerative colitis is moderate to severe, with a Mayo score of 6-12 and an endoscopy subscore of 2 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had infections like histoplasmosis or similar conditions before.

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

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

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I have had a blockage in my intestines within the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 74 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 74 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 74 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Global: Number of Participants with Clinical Remission at Induction Week 8 (I-8) Visit

Number of Participants with AEs Leading to Discontinuation of Study Intervention

Number of Participants with AEs of Special Interest (AESI) as a Measure of Safety and Tolerability

+6 more

Secondary study objectives

Clinical Remission at I-8 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score

Clinical Remission at M-44 and not Receiving Corticosteroids for at Least 90 Days Prior to M-44 Among Participants who Received Corticosteroids at M-0

Clinical Remission at M-44 as Assessed by the PUCAI Score

+11 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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 \[mg/kg\]).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Matching Placebo

2012

Completed Phase 4

~10710

0 / 7Eligibility criteria met