← Back to Search

Monoclonal Antibodies

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

Q: How many people are enrolling in this clinical trial?

<p>Janssen Research &#x26; Development, LLC, the sponsor for this trial, needs to recruit a total of ninety participants that meet the requirements for inclusion. The trial will take place in multiple locations, such as Nemours DuPont Hospital for Children in Wilmington, <a href="https://www.withpower.com/clinical-trials/delaware">Delaware</a> and Children's Center for Digestive Health Care in Atlanta, <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a>.</p>

Q: What primary goals does this experiment hope to establish?

<p>Janssen Research &#x26; Development, LLC, the sponsor for this study, has defined the primary outcome as the Number of Participants with Clinical Remission at Induction Week 8. This will be measured over a Up to Week 74 period. Additionally, the trial will be evaluating secondary outcomes including the Number of Participants with Endoscopic Response as Assessed by Simplified Endoscopic Score-<a href="https://www.withpower.com/clinical-trials/crohn&#x27;s-disease">Crohn's disease</a> (SES-CD), which is defined as the Number of participants with endoscopic response as assessed by SES-CD in the maintenance period. Endoscopic response is defined as a reduction in SES-CD score of >= 50 percent (%)</p>

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 Crohn's disease or fistulizing Crohn's disease with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by endoscopy and histology

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 74

Awards & highlights

UNITI Jr Trial Summary

This trial is testing a drug to see if it can help kids with Crohn's disease by putting them into remission and helping them stay in remission. It will also check for any safety concerns and how the drug is processed by the body.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While not specified here, common side effects of Ustekinumab may include respiratory infections, headache, tiredness, itching at the injection site, nausea/vomiting. Serious side effects could involve allergic reactions or increased risk of infection.

UNITI Jr Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

UNITI Jr Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 74

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 74

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

Treatment Details

Study Objectives

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

Primary outcome measures

Number of Participants with AEs leading to Discontinuation of Study Intervention

Number of Participants with AEs of Interest

Number of Participants with Abnormalities in Clinical Laboratory Parameters

+7 more

Secondary outcome measures

Number of Participants with Clinical Remission

Number of Participants with Clinical Remission as Assessed by short Pediatric Crohn's Disease Activity Index (sPCDAI)

Number of Participants with Clinical Remission at Week 44 (Maintenance Period) who are in Clinical Remission at Week 8 (Induction Period)

+5 more

Side effects data

From 2018 Phase 4 trial • 43 Patients • NCT02187172

50%

Upper respiratory infection

27%

Common cold

Urinary tract infection

Anxiety

Back pain

Dizziness

Fracture

Skin and subcutaneous tissue disorders

Rash/Rash Acneiform/Maculo-Papular

Hypertension

Pain/Pain in extremity

Toothache

100%

80%

60%

40%

20%

Study treatment Arm

Ustekinumab (Stelara)

Placebo (RCT Period)

Placebo (Active Treatment Period)

UNITI Jr Trial Design

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]).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ustekinumab

2013

Completed Phase 4

~4140

Placebo

1995

Completed Phase 3

~2670

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,207 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,804 Total Patients Enrolled

Media Library

Ustekinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04673357 — Phase 3

Crohn's Disease Research Study Groups: Ustekinumab SC Every 12 Weeks (q12w): Maintenance Period, Open- Label Ustekinumab Intravenous (IV): Induction Period, Ustekinumab Subcutaneous (SC) Every 8 Weeks (q8w): Maintenance Period

Crohn's Disease Clinical Trial 2023: Ustekinumab Highlights & Side Effects. Trial Name: NCT04673357 — Phase 3

Ustekinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04673357 — Phase 3

Frequently Asked Questions

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

Does this research include patients that are over the age of 40?

"According to the terms set out by the researchers, children aged 2 to 17 can enroll in this trial. There are currently 79 clinical trials recruiting patients who are under 18 and 224 recruiting patients that are over 65."

Answered by AI

How many people are enrolling in this clinical trial?

"Janssen Research & Development, LLC, the sponsor for this trial, needs to recruit a total of ninety participants that meet the requirements for inclusion. The trial will take place in multiple locations, such as Nemours DuPont Hospital for Children in Wilmington, Delaware and Children's Center for Digestive Health Care in Atlanta, Georgia."

Answered by AI

Are there similar ongoing research projects that use Ustekinumab?

"Right now, 35 clinical trials studying Ustekinumab are ongoing. Out of these, 18 are in Phase 3. 2789 locations worldwide are running these trials, with a notable concentration in Gdansk, Pomorskie."

Answered by AI

What primary goals does this experiment hope to establish?

"Janssen Research & Development, LLC, the sponsor for this study, has defined the primary outcome as the Number of Participants with Clinical Remission at Induction Week 8. This will be measured over a Up to Week 74 period. Additionally, the trial will be evaluating secondary outcomes including the Number of Participants with Endoscopic Response as Assessed by Simplified Endoscopic Score-Crohn's disease (SES-CD), which is defined as the Number of participants with endoscopic response as assessed by SES-CD in the maintenance period. Endoscopic response is defined as a reduction in SES-CD score of >= 50 percent (%)"

Answered by AI

Who meets the requirements to be a subject in this experiment?

"Given that the study is investigating ileocolitis, only patients with this condition between the ages of 2-17 will be accepted. They will be joining the approximately 90 other individuals currently enrolled in the trial."

Answered by AI

What kind of short- and long-term effects does Ustekinumab have on patients?

"Ustekinumab is in Phase 3 of clinical trials, meaning that there is both efficacy and safety data available. Consequently, our team has given it a safety score of 3."

Answered by AI

Are there any unfilled participant positions in this research project?

"This study is actively recruiting patients, as reported on clinicaltrials.gov. The clinical trial was first posted on 4/6/2021 and was most recently edited on 10/12/2022."

Answered by AI

What are the most common afflictions that Ustekinumab is used to target?

"Ustekinumab is the standard medication for treating adrenal cortex hormones. This drug is also helpful for patients that have not responded well to other TNF antagonist therapies, those with psoriasis, and those with severe Crohn's disease."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

2021. "A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04673357.

All > Crohns Disease