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A Long-term Extension Study of Ustekinumab in Pediatric Participants (UNITED)

Primary Purpose

Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ustekinumab
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Crohn Disease

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Center For Digestive Healthcare, LlcRecruiting
  • Mount SinaiRecruiting
  • Centro de Investigaciones Medicas TucumanRecruiting
  • Cliniques Universitaires Saint-LucRecruiting
  • HuderfRecruiting
  • UZ GentRecruiting
  • UZ BrusselRecruiting
  • Uz GasthuisbergRecruiting
  • Hôpital NeckerRecruiting
  • Universitaetsklinikum der RWTH AachenRecruiting
  • Charité - Universitätsmedizin Berlin, Campus Virchow KlinikumRecruiting
  • Semmelweis EgyetemRecruiting
  • Debreceni Egyetem Klinikai KozpontRecruiting
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato KorhazRecruiting
  • Szabolcs Szatmar Bereg Varmegyei OktatokorhazRecruiting
  • Juntendo University HospitalRecruiting
  • Gunma University HospitalRecruiting
  • Miyagi Children's HospitalRecruiting
  • National Center for Child Health and DevelopmentRecruiting
  • Uniwersytecki Szpital Dzieciecy w KrakowieRecruiting
  • Korczowski Bartosz, Gabinet LekarskiRecruiting
  • WIP Warsaw IBD Point Profesor KierkusRecruiting
  • Instytut Pomnik - Centrum ZdrowiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ustekinumab

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
Number of Participants With AEs of Worsening of the Disease
Number of participants with AEs of worsening of the disease will be reported.
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.

Secondary Outcome Measures

Full Information

First Posted
October 13, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05092269
Brief Title
A Long-term Extension Study of Ustekinumab in Pediatric Participants
Acronym
UNITED
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
September 29, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
151 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ustekinumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab
Other Intervention Name(s)
STELARA
Intervention Description
Ustekinumab will be administered as a SC injection.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
Up to 6 years and 4 months
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to 6 years and 4 months
Title
Number of Participants with AEs Leading to Discontinuation of Study Intervention
Description
Number of participants with AEs leading to discontinuation of study intervention will be reported.
Time Frame
Up to 6 years and 4 months
Title
Number of Participants with AEs of Interest
Description
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.
Time Frame
Up to 6 years and 4 months
Title
Number of Participants with Abnormalities in Clinical Laboratory Parameters
Description
Number of participants with abnormalities in clinical laboratory parameters (such as hematology and serum chemistry) will be reported.
Time Frame
Up to 6 years and 4 months
Title
Number of Participants with Injection-site Reactions
Description
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.
Time Frame
Up to 6 years and 4 months
Title
Number of Participants With AEs of Worsening of the Disease
Description
Number of participants with AEs of worsening of the disease will be reported.
Time Frame
Up to 6 years and 4 months
Title
Number of Participants With Concomitant Therapy due to Loss of Response
Description
Number of participants with concomitant therapy due to loss of response will be reported.
Time Frame
Up to 6 years and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Children's Center For Digestive Healthcare, Llc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones Medicas Tucuman
City
San Miguel De Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Huderf
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Uz Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Hôpital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum der RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Juntendo University Hospital
City
Bunkyo-Ku
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gunma University Hospital
City
Gunma
ZIP/Postal Code
371-0034
Country
Japan
Individual Site Status
Recruiting
Facility Name
Miyagi Children's Hospital
City
Sendai
ZIP/Postal Code
989-3126
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Center for Child Health and Development
City
Setagaya-ku
ZIP/Postal Code
157-8535
Country
Japan
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Dzieciecy w Krakowie
City
Krakow
ZIP/Postal Code
30-663
Country
Poland
Individual Site Status
Recruiting
Facility Name
Korczowski Bartosz, Gabinet Lekarski
City
Rzeszow
ZIP/Postal Code
35-302
Country
Poland
Individual Site Status
Recruiting
Facility Name
WIP Warsaw IBD Point Profesor Kierkus
City
Warszawa
ZIP/Postal Code
00-728
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut Pomnik - Centrum Zdrowia
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Long-term Extension Study of Ustekinumab in Pediatric Participants

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