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Monoclonal Antibodies

Ustekinumab for Pediatric Crohn's Disease (UNITI 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 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
Must not have
Have a history of moderate or severe progressive or uncontrolled liver or renal insufficiency; or significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric (including suicidality), or metabolic disturbances
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 week 74
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have Crohn's disease with active inflammation, confirmed by a past endoscopy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe ongoing issues with my liver, kidneys, heart, lungs, or other major systems.
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I have or had cancer or symptoms that might suggest blood cancer.
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I have had infections like histoplasmosis or similar conditions before.
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I have Crohn's disease complications that might need surgery.

Timeline

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
9%
Urinary tract infection
9%
Anxiety
9%
Back pain
9%
Dizziness
9%
Fracture
9%
Skin and subcutaneous tissue disorders
5%
Rash/Rash Acneiform/Maculo-Papular
5%
Hypertension
5%
Pain/Pain in extremity
5%
Toothache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ustekinumab (Stelara)
Placebo (RCT Period)
Placebo (Active Treatment Period)

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Crohn's Disease, particularly biologic therapies, work by targeting specific components of the immune system to reduce inflammation. Ustekinumab, a monoclonal antibody, targets interleukin-12 (IL-12) and interleukin-23 (IL-23), which are cytokines involved in the inflammatory response. By inhibiting these cytokines, ustekinumab helps to decrease the chronic inflammation characteristic of Crohn's Disease. This is crucial for patients as it can lead to clinical remission, reduce symptoms, and improve quality of life. Other biologics, such as anti-TNF agents, work by neutralizing tumor necrosis factor-alpha (TNF-α), another key player in inflammation. These targeted therapies are essential because they offer a more precise approach to managing the disease compared to traditional immunosuppressants, potentially leading to better outcomes and fewer side effects.
Metabolic Host-Microbiota Interactions in Autophagy and the Pathogenesis of Inflammatory Bowel Disease (IBD).

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
980 Previous Clinical Trials
6,384,192 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
749 Previous Clinical Trials
3,960,846 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
~24 spots leftby Jul 2025