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Active, Not Recruiting

NCT Number: NCT05092269

A Long-term Extension Study of Ustekinumab in Pediatric Participants

The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Crohn Disease Arthritis Arthritis, Psoriatic Bone Diseases Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

STAT Research S A, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ustekinumab

Drug

Ustekinumab will be administered as a SC injection.

Other names: STELARA

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 6 years and 4 months

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.

  2. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: Up to 6 years and 4 months

    A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  3. Number of Participants with AEs Leading to Discontinuation of Study Intervention

    Time frame: Up to 6 years and 4 months

    Number of participants with AEs leading to discontinuation of study intervention will be reported.

  4. Number of Participants with AEs of Interest

    Time frame: Up to 6 years and 4 months

    Number of participants with AEs of special interest (any newly identified malignancy case of active tuberculosis [TB], or opportunistic infection occurring after the first administration of study intervention[s]) will be reported.

  5. Number of Participants with Abnormalities in Clinical Laboratory Parameters

    Time frame: Up to 6 years and 4 months

    Number of participants with abnormalities in clinical laboratory parameters (such as hematology and serum chemistry) will be reported.

  6. Number of Participants with Injection-site Reactions

    Time frame: Up to 6 years and 4 months

    Number of participants with injection-site reactions will be reported. An injection-site reaction is any adverse reaction at a subcutaneous (SC) study intervention injection-site.

  7. Number of Participants With AEs of Worsening of the Disease

    Time frame: Up to 6 years and 4 months

    Number of participants with AEs of worsening of the disease will be reported.

  8. Number of Participants With Concomitant Therapy due to Loss of Response

    Time frame: Up to 6 years and 4 months

    Number of participants with concomitant therapy due to loss of response will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Acronym: UNITED

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Oct 25, 2021
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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