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En långtidsförlängningsstudie av Ustekinumab hos pediatriska deltagare (UNITED)

2 november 2026 uppdaterad av: Janssen Research & Development, LLC

En fas 3, multicenter, öppen etikett, korg, långtidsförlängningsstudie av Ustekinumab i deltagare i pediatriska kliniska studie (2 till

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

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

159

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Argentina
      • Buenos Aires, Argentina, C1060
        • STAT Research S A
      • Córdoba, Argentina, X5014FTO
        • Hospital de Ninos de Cordoba
      • San Miguel de Tucumán, Argentina, T4000AXL
        • Centro de Investigaciones Medicas Tucuman
  • Belgien
      • Brussels, Belgien, 1200
        • Cliniques Universitaires Saint Luc
      • Brussels, Belgien, 1020
        • Huderf
      • Ghent, Belgien, 9000
        • UZ Gent
      • Jette, Belgien, 1090
        • UZ Brussel
      • Leuven, Belgien, 3000
        • Uz Gasthuisberg
  • Frankrike
      • Paris, Frankrike, 75015
        • Hôpital Necker
  • Förenta staterna
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30342
        • Children's Center For Digestive Healthcare, Llc
    • New York
      • New York, New York, Förenta staterna, 10029
        • Mount Sinai
    • North Carolina
      • Charlotte, North Carolina, Förenta staterna, 28207
        • Levine Childrens at Atrium Health
    • Virginia
      • Fairfax, Virginia, Förenta staterna, 22031
        • Pediatric Specialists Of Virginia
  • Israel
      • Beer Yaakov, Israel, 70300
        • Yitzhak Shamir Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Ramat Gan, Israel, 5266202
        • Sheba Medical Center
  • Italien
      • Milan, Italien, 20122
        • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
  • Japan
      • Bunkyō City, Japan, 113 8431
        • Juntendo University Hospital
      • Gunma, Japan, 371-0034
        • Gunma University Hospital
      • Ikoma, Japan, 630 0293
        • Kindai University Nara Hospital
      • Kurume, Japan, 830-0011
        • Kurume University Hospital
      • Saitama Shi, Japan, 330-8777
        • Saitama Childrens Medical Center
      • Sendai, Japan, 989-3126
        • Miyagi Childrens Hospital
      • Setagaya Ku, Japan, 157 8535
        • National Center for Child Health and Development
      • Tsu, Japan, 514 8507
        • Mie University Hospital
  • Polen
      • Krakow, Polen, 30 663
        • Uniwersytecki Szpital Dzieciecy w Krakowie
      • Rzeszów, Polen, 35-302
        • Korczowski Bartosz Gabinet Lekarski
      • Sosnowiec, Polen, 41 200
        • Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
      • Torun, Polen, 87 100
        • GASTROMED Sp. z o.o.
      • Warsaw, Polen, 04 730
        • Instytut Pomnik Centrum Zdrowia Dziecka
      • Warsaw, Polen, 04-501
        • Medical Network
      • Warsaw, Polen, 04-501
        • Medical Network 1
  • Spanien
      • Valencia, Spanien, 46026
        • Hosp. Univ. I Politecni La Fe
  • Storbritannien
      • Birmingham, Storbritannien, B4 6NH
        • Birmingham Children's Hospital
      • Cambridge, Storbritannien, Cb2 2qq
        • Addenbrookes Hospital
      • London, Storbritannien, E1 1BB
        • Royal London Hospital
      • London, Storbritannien, WC1N 3JH
        • Great Ormond Street Hospital
      • Sheffield, Storbritannien, S10 2TH
        • Sheffield Children's Hospital
      • Southampton, Storbritannien, SO16 6YD
        • Southampton University Hospital
  • Turkiet (Türkiye)
      • Ankara, Turkiet (Türkiye), 06230
        • Hacettepe University Medical Faculty
      • Istanbul, Turkiet (Türkiye), 34098
        • Cerrahpasa Medical Faculty Hospital
  • Tyskland
      • Aachen, Tyskland, 52074
        • Universitaetsklinikum der RWTH Aachen
      • Berlin, Tyskland, 13353
        • Charite Universitatsmedizin Berlin Campus Virchow Klinikum
  • Ungern
      • Budapest, Ungern, 1083
        • Semmelweis Egyetem
      • Debrecen, Ungern, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Miskolc, Ungern, 3526
        • Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
      • Nyíregyháza, Ungern, 4400
        • Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
      • Szeged, Ungern, 6720
        • Szegedi Tudomanyegyetem

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

2 år till 17 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Ustekinumab

Participants will have continued access to ustekinumab for primary study (CNTO1275CRD1001, CNTO1275PUC3001, CNTO1275CRD3004, CNTO1275JPA3001) participants who in the opinion of the investigator will continue to benefit from ustekinumab therapy. All blinded participants who enroll in the long-term extension (LTE) from blinded primary studies with both every 8 weeks (q8w) and every 12 weeks (q12w) dosing groups just prior to the end of the primary study will be assigned to the q8w dosing regimen. Participants enrolling in the LTE from an unblinded primary study will remain on the final dosing regimen that they were receiving in the primary study. Participants enrolling from the Exposure Optimization Substudy may be eligible to remain on the every 4 weeks (q4w) dosing regimen.
Läkemedel: Ustekinumab

Ustekinumab will be administered as a SC injection.

Andra namn:
  • STELARA

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Adverse Events (AEs)
Tidsram: 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.
Up to 6 years and 4 months
Number of Participants With Serious Adverse Events (SAEs)
Tidsram: 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.
Up to 6 years and 4 months
Number of Participants with AEs Leading to Discontinuation of Study Intervention
Tidsram: Up to 6 years and 4 months

Number of participants with AEs leading to discontinuation of study intervention will be reported.
Up to 6 years and 4 months
Number of Participants with AEs of Interest
Tidsram: 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.
Up to 6 years and 4 months
Number of Participants with Abnormalities in Clinical Laboratory Parameters
Tidsram: 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.
Up to 6 years and 4 months
Number of Participants with Injection-site Reactions
Tidsram: 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.
Up to 6 years and 4 months
Number of Participants With AEs of Worsening of the Disease
Tidsram: Up to 6 years and 4 months

Number of participants with AEs of worsening of the disease will be reported.
Up to 6 years and 4 months
Number of Participants With Concomitant Therapy due to Loss of Response
Tidsram: Up to 6 years and 4 months

Number of participants with concomitant therapy due to loss of response will be reported.
Up to 6 years and 4 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Janssen Research & Development, LLC

Utredare

  • Studierektor: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

18 oktober 2021

Primärt slutförande (Beräknad)

29 september 2027

Avslutad studie (Beräknad)

15 mars 2028

Studieregistreringsdatum

Först inskickad

13 oktober 2021

Först inskickad som uppfyllde QC-kriterierna

13 oktober 2021

Första postat (Faktisk)

25 oktober 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CR109074
  • 2020-004457-76 (EudraCT-nummer)
  • CNTO1275ISD3001 (Annan identifierare: Janssen Research & Development, LLC)
  • 2022-501067-40-00 (Registeridentifierare: EUCT number)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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