What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease, such as ustekinumab, anti-TNF agents, and vedolizumab, have known side effects. Ustekinumab can cause infections and nasopharyngitis. Anti-TNF agents may lead to increased risk of infections, injection site reactions, and antibody development against the drug. Vedolizumab can result in headaches, joint pain, and infusion-related reactions. These treatments are effective in reducing inflammation but require careful management of their associated risks.

What prior FDA approvals exist?

The FDA has approved several biologic therapies for the treatment of Crohn's Disease, particularly monoclonal antibodies targeting specific cytokines. Ustekinumab, which targets interleukin-12 (IL-12) and interleukin-23 (IL-23), is one such therapy. Other similar biologics include infliximab, adalimumab, and certolizumab pegol, which are anti-TNF (tumor necrosis factor) agents. These drugs work by inhibiting TNF, a cytokine involved in systemic inflammation. Vedolizumab, another approved biologic, targets integrin α4β7 and is used to reduce gut-specific inflammation. These therapies have been pivotal in managing moderate to severe Crohn's Disease, especially in patients who do not respond to conventional treatments.

What other types of research exist?

Promising novel alternatives to Ustekinumab for Crohn's Disease patients include Vedolizumab (a monoclonal antibody targeting integrin α4β7), Tofacitinib (an oral Janus kinase inhibitor), and Risankizumab (a monoclonal antibody targeting IL-23). These agents have shown efficacy and safety in clinical trials and offer different mechanisms of action compared to Ustekinumab.

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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

Pivotal Trial

Summary

This trial is testing a medication that reduces inflammation in children with severe Crohn's disease. The goal is to see if it can help them get better and stay better. The study will also check how safe the medication is and how it works in 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.

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.

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 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

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

Primary study objectives

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 study objectives

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

Skin and subcutaneous tissue disorders

Fracture

Anxiety

Dizziness

Back pain

Urinary tract infection

Toothache

Rash/Rash Acneiform/Maculo-Papular

Hypertension

Pain/Pain in extremity

100%

80%

60%

40%

20%

Study treatment Arm

Ustekinumab (Stelara)

Placebo (RCT Period)

Placebo (Active Treatment Period)

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: 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

2015

Completed Phase 4

~4080

Placebo

1995

Completed Phase 3

~2670

0 / 5Eligibility criteria met

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).