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Monoclonal Antibodies

Ustekinumab for Ulcerative Colitis(UNIFI Jr Trial)

Phase 3
Recruiting
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
A participant who has had extensive colitis for >= 8 years, or disease limited to the left side of the colon for >= 10 years, must: a) have had a full colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study intervention or b) have a full colonoscopy with surveillance for dysplasia as the baseline endoscopy during the screening period. Results from these surveillance biopsies must be negative for dysplasia (low-grade, high-grade, or indeterminant) prior to the first administration of study intervention
Females of childbearing potential must have a negative highly sensitive urine pregnancy test at screening and at Week I-0 prior to study intervention administration
Must not have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 74 weeks
Awards & highlights
Pivotal Trial

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.

Eligible Conditions
  • Ulcerative Colitis

UNIFI Jr Trial Eligibility Criteria

Inclusion Criteria

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

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

Awards & Highlights

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

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
964 Previous Clinical Trials
6,381,095 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
739 Previous Clinical Trials
3,958,379 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the relationship between the drug Ustekinumab and the FDA's BSA and Body Weight guidelines?

"Ustekinumab Dose Based on BSA and Body Weight is thought to be safe, as it is a Phase 3 trial. This means that not only is there some data supporting efficacy, but multiple rounds of data also support safety."

Answered by AI

What is Ustekinumab Dose Based on BSA and Body Weight typically used to manage?

"Ustekinumab Dose Based on BSA and Body Weight is a medication that can be used to target adrenal cortex hormones. Furthermore, it can also be used to ameliorate conditions such as an insufficient response to one or more tnf antagonist therapies, psoriasis, and severe, active crohn´s disease."

Answered by AI

Would this clinical trial be interested in enrolling patients who are octogenarians?

"The age bracket for this clinical trial are patients who are 2 years old and up, but no older than 17 years old."

Answered by AI

Who does this clinical trial consider to be an eligible participant?

"This study is recruiting 100 people, between the ages of 2 and 17, who have colitis or ulcerative colitise colitis or ulcerative colitis. Patients must also meet the following criteria: they must be medically stable on the basis of physical examination, medical history, and vital signs; they must have had UC diagnosed prior to screening; they must have moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with a screening Mayo endoscopy subscore greater than or equal to (>=) 2 as determined by a central review of the video of the endoscopy; a participant who has had extensive col"

Answered by AI

Are there other instances where Ustekinumab Dose was administered based on BSA and Body Weight?

"As of right now, 35 clinical trials that are investigating Ustekinumab Dose Based on BSA and Body Weight are ongoing with 18 of those trials in Phase 3. Out of the 2840 total locations for clinical trials, most of the trials for Ustekinumab Dose Based on BSA and Body Weight are running out of Gdansk, Pomorskie."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)
2021. "A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04630028.
All > Ulcerative Colitis > Colitis
~37 spots leftby Jul 2025
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