A Long-term Extension Study of Ustekinumab in Pediatric Participants

NCT05092269 | Active Not Recruiting Phase 3 FDA Drug

• 4 other identifiers: CR109074CNTO1275ISD30012020-004457-762022-501067-40-00
• Study Type: interventional
• Target: 159
• Locations: 13 countries
• Sites: 48

Brief Summary

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

Conditions

Colitis, Ulcerative; Crohn Disease; Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (8)

• Number of Participants With Adverse Events (AEs)

  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)

  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

  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

  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

  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

  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

  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

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

  Up to 6 years and 4 months

Study Arms (1)

Ustekinumab

EXPERIMENTAL

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.

Drug: Ustekinumab

Interventions

Ustekinumab DRUG

Ustekinumab will be administered as a SC injection.

Also known as: STELARA

Ustekinumab

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (48)

Children's Center For Digestive Healthcare, Llc

Atlanta, Georgia, 30342, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Levine Childrens at Atrium Health

Charlotte, North Carolina, 28207, United States

Location

Pediatric Specialists Of Virginia

Fairfax, Virginia, 22031, United States

Location

STAT Research S A

Buenos Aires, C1060, Argentina

Location

Hospital de Ninos de Cordoba

Córdoba, X5014FTO, Argentina

Location

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, T4000AXL, Argentina

Location

Huderf

Brussels, 1020, Belgium

Location

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Brussel

Jette, 1090, Belgium

Location

Uz Gasthuisberg

Leuven, 3000, Belgium

Location

Hôpital Necker

Paris, 75015, France

Location

Universitaetsklinikum der RWTH Aachen

Aachen, 52074, Germany

Location

Charite Universitatsmedizin Berlin Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz

Miskolc, 3526, Hungary

Location

Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz

Nyíregyháza, 4400, Hungary

Location

Szegedi Tudomanyegyetem

Szeged, 6720, Hungary

Location

Yitzhak Shamir Medical Center

Beer Yaakov, 70300, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Sheba Medical Center

Ramat Gan, 5266202, Israel

Location

Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano

Milan, 20122, Italy

Location

Juntendo University Hospital

Bunkyō City, 113 8431, Japan

Location

Gunma University Hospital

Gunma, 371-0034, Japan

Location

Kindai University Nara Hospital

Ikoma, 630 0293, Japan

Location

Kurume University Hospital

Kurume, 830-0011, Japan

Location

Saitama Childrens Medical Center

Saitama Shi, 330-8777, Japan

Location

Miyagi Children's Hospital

Sendai, 989-3126, Japan

Location

National Center for Child Health and Development

Setagaya Ku, 157 8535, Japan

Location

Mie University Hospital

Tsu, 514 8507, Japan

Location

Uniwersytecki Szpital Dzieciecy w Krakowie

Krakow, 30 663, Poland

Location

Korczowski Bartosz Gabinet Lekarski

Rzeszów, 35-302, Poland

Location

Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o

Sosnowiec, 41 200, Poland

Location

GASTROMED Sp. z o.o.

Torun, 87 100, Poland

Location

Instytut Pomnik Centrum Zdrowia Dziecka

Warsaw, 04 730, Poland

Location

Medical Network 1

Warsaw, 04-501, Poland

Location

Medical Network

Warsaw, 04-501, Poland

Location

Hosp. Univ. I Politecni La Fe

Valencia, 46026, Spain

Location

Hacettepe University Medical Faculty

Ankara, 06230, Turkey (Türkiye)

Location

Cerrahpasa Medical Faculty Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

Birmingham Children's Hospital

Birmingham, B4 6NH, United Kingdom

Location

Addenbrookes Hospital

Cambridge, Cb2 2qq, United Kingdom

Location

Royal London Hospital

London, E1 1BB, United Kingdom

Location

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

Location

Sheffield Children's Hospital

Sheffield, S10 2TH, United Kingdom

Location

Southampton University Hospital

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Arthritis, Psoriatic

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 25, 2021
• Study Start: October 18, 2021
• Primary Completion (Estimated): September 29, 2027
• Study Completion (Estimated): March 15, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IL (3); DE (2); IT (1); AR (3); BE (5); PL (7); ES (1); HU (5); TU (2); US (4); FR (1); JP (8); GB (6)