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Long-term treatment with ustekinumab for children with inflammatory bowel diseases

A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age)

Phase 3 Interventional Janssen Research & Development, LLC · NCT05092269

This study is testing the long-term safety of a medication called ustekinumab in children with inflammatory bowel diseases who have already shown improvement from their condition.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment151 (estimated)
Ages2 Years to 17 Years
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsustekinumab
Locations42 sites (Atlanta, Georgia and 41 other locations)
Trial IDNCT05092269 on ClinicalTrials.gov

What this trial studies

This study aims to gather long-term safety data on the use of subcutaneous ustekinumab in pediatric patients who have previously participated in a primary study. Participants must have shown a clinical response or remission from their condition at the end of the primary study. The study will involve ongoing monitoring and assessment of the treatment's effects over an extended period. The focus is on children with conditions such as Crohn's disease, ulcerative colitis, and related inflammatory disorders.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients who have completed the primary ustekinumab study and demonstrated a clinical response or remission.

Not a fit: Patients who have not previously responded to ustekinumab or who have not completed the primary study will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and efficacy of ustekinumab for children with inflammatory bowel diseases.

How similar studies have performed: Other studies have shown positive outcomes with ustekinumab in treating inflammatory bowel diseases, indicating a promising approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Must have completed the dosing planned in the primary pediatric ustekinumab study
* Benefit of continued ustekinumab therapy (that is, a clinical response or clinical remission as defined in the primary study at the final efficacy visit of the primary study)
* Parent(s) (preferably both if available or as per local requirements), legal guardian(s) or their legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) as described in Informed Consent Process. An adolescent who signs the assent form will be given the opportunity to sign an adult ICF at a later visit when they reach the age of majority during the study to indicate that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
* Females of childbearing potential must have a negative urine pregnancy test at enrollment and prior to study intervention administration

Exclusion Criteria:

* Are pregnant, nursing, or planning pregnancy or fathering a child
* Have had any of (a) confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2 \[COVID-19\]) infection (test positive), or (b) suspected SARS-CoV-2 infection (clinical features without documented test results), or (c) close contact with a person with known or suspected SARS-CoV-2 infection: Exception: (i) may be included with a documented negative result for a validated SARS-CoV-2 test: obtained at least 2 weeks after conditions (a), (b), (c) above (timed from resolution of key clinical features if present, example, fever, cough, dyspnea) and (ii) with absence of all conditions (a), (b), (c) above during the period between the negative test result and the baseline study visit
* Taken any disallowed therapies as noted in the primary study, before the planned first long-term extension (LTE) dose of study intervention
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Participants who receive a live vaccination may be permitted to remain in the study, if approved by the sponsor and study intervention is held for a period of time specified by the sponsor. Receipt of a live severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) vaccine (against the virus that causes Coronavirus Disease 2019 \[COVID-19\]) is not automatically an exclusion criterion and must be discussed with the medical monitor

Where this trial is running

Atlanta, Georgia and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn DiseaseColitis, UlcerativeArthritis, Psoriatic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.