Ustekinumab for Pediatric Crohn's Disease
(UNITI Jr Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is ustekinumab safe for children with Crohn's disease?
How is the drug ustekinumab unique for treating pediatric Crohn's disease?
Ustekinumab is unique because it targets specific proteins (interleukin-12 and interleukin-23) involved in inflammation, offering a different approach than traditional treatments like corticosteroids or TNF antagonists. It is administered as an intravenous induction followed by subcutaneous maintenance, and has shown promise in children who have not responded to other treatments.23456
What data supports the effectiveness of the drug ustekinumab for pediatric Crohn's disease?
Research shows that ustekinumab, a drug used for Crohn's disease, led to clinical remission in about 50% of patients after one year. Additionally, a 10-year-old girl with Crohn's disease achieved remission without adverse effects after using ustekinumab, suggesting it may be effective and safe for children.23457
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
All participants receive a single IV administration of ustekinumab based on body surface area or weight-tiered induction dose
Maintenance
Participants receive SC administration of ustekinumab every 8 or 12 weeks based on BSA or weight-tiered induction dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Ustekinumab
Ustekinumab is already approved in European Union, United States, Canada, Japan for the following indications:
- Moderate to severe plaque psoriasis
- Psoriatic arthritis
- Crohn's disease
- Ulcerative colitis
- Moderate to severe plaque psoriasis
- Active psoriatic arthritis
- Moderately to severely active Crohn's disease
- Moderately to severely active ulcerative colitis
- Moderate to severe plaque psoriasis
- Active psoriatic arthritis
- Moderately to severely active Crohn's disease
- Moderately to severely active ulcerative colitis
- Plaque psoriasis
- Psoriatic arthritis
- Crohn's disease
- Ulcerative colitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University