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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 74 weeks
Awards & highlights

UNIFI Jr 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.Check my eligibility
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.See study design
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.

UNIFI Jr Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My ulcerative colitis is moderate to severe, with a Mayo score of 6-12.
Select...
I was diagnosed with ulcerative colitis before screening.
Select...
My ulcerative colitis is moderate to severe, with a Mayo score of 6-12 and an endoscopy subscore of 2 or more.

UNIFI Jr Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

UNIFI Jr 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

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
978 Previous Clinical Trials
6,384,981 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
1,626 Patients Enrolled for Ulcerative Colitis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
747 Previous Clinical Trials
3,960,559 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
1,626 Patients Enrolled for Ulcerative Colitis

Media Library

Ustekinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04630028 — Phase 3
Ulcerative Colitis Research Study Groups: Induction Period (I): Ustekinumab, Maintenance (M) Period: Ustekinumab once every 12 Week (q12w), Maintenance (M) Period: Ustekinumab once every 8 Week (q8w)
Ulcerative Colitis Clinical Trial 2023: Ustekinumab Highlights & Side Effects. Trial Name: NCT04630028 — Phase 3
Ustekinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04630028 — Phase 3
~28 spots leftby Jul 2025
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