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A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC) (UNIFI Jr)

Primary Purpose

Colitis, Ulcerative

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ustekinumab Dose Based on BSA and Body Weight
Matching Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative

Eligibility Criteria

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

Inclusion Criteria:

  • Medically stable on the basis of physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator
  • Must have had UC diagnosed prior to screening
  • Have moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with a screening Mayo endoscopy subscore greater than or equal to (>=) 2 as determined by a central review of the video of the endoscopy
  • A participant who has had extensive colitis for >= 8 years, or disease limited to the left side of the colon for >= 10 years, must: a) have had a full colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study intervention or b) have a full colonoscopy with surveillance for dysplasia as the baseline endoscopy during the screening period. Results from these surveillance biopsies must be negative for dysplasia (low-grade, high-grade, or indeterminant) prior to the first administration of study intervention
  • Females of childbearing potential must have a negative highly sensitive urine pregnancy test at screening and at Week I-0 prior to study intervention administration

Exclusion Criteria:

  • Have UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon
  • Presence or history of colonic or small bowel obstruction within 6 months prior to screening, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy)
  • Have a history of latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to screening
  • Presence or history of any malignancy including presence or history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (example, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas) and monoclonal gammopathy of undetermined significance, or clinically significant hepatomegaly or splenomegaly
  • Has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients

Sites / Locations

  • Nemours DuPont Hospital for ChildrenRecruiting
  • Children's Center for Digestive Health CareRecruiting
  • Mayo ClinicRecruiting
  • Morristown Memorial HospitalRecruiting
  • Levine Children's at Atrium HealthRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • Penn State Hershey Children's HospitalRecruiting
  • Cook Childrens Medical CenterRecruiting
  • Pediatric Specialists Of VirginiaRecruiting
  • Universitair Kinderziekenhuis Koningin FabiolaRecruiting
  • Cliniques Universitaires Saint-LucRecruiting
  • UZ GentRecruiting
  • UZ BrusselRecruiting
  • UZ LeuvenRecruiting
  • Universitätsklinikum AachenRecruiting
  • Charite-Universitätsmedizin Berlin - BerlinRecruiting
  • Universitatsklinikum EssenRecruiting
  • Medizinische Hochschule Hannover
  • Dr. von Haunersches KinderspitalRecruiting
  • KUNO Klinik St. HedwigRecruiting
  • Universitatsklinikum Ulm
  • Semmelweis EgyetemRecruiting
  • Debreceni Egyetem Klinikai KozpontRecruiting
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato KorhazRecruiting
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras OktatokorhazRecruiting
  • Szegedi Tudományegyetem, Gyermekgyógyászati Klinika és Gyermekegészségügyi CentrumRecruiting
  • Shamir Medical Center (Assaf Harofeh)Recruiting
  • Rambam Medical CenterRecruiting
  • Carmel Medical CenterRecruiting
  • Shaare Zedek Medical CenterRecruiting
  • Schneider Children's Medical CenterRecruiting
  • Sheba Medical CenterRecruiting
  • Juntendo University HospitalRecruiting
  • Gunma University HospitalRecruiting
  • Kindai University Nara HospitalRecruiting
  • Kurume University HospitalRecruiting
  • Saitama Children's Medical CenterRecruiting
  • Miyagi Children's HospitalRecruiting
  • National Center for Child Health and DevelopmentRecruiting
  • Jichi Medical University HospitalRecruiting
  • Mie University HospitalRecruiting
  • Szpital im. M. Kopernika
  • Uniwersytecki Szpital Dzieciecy w KrakowieRecruiting
  • Korczowski Bartosz, Gabinet LekarskiRecruiting
  • GASTROMED Sp. z o.o.Recruiting
  • WIP Warsaw IBD Point Profesor KierkusRecruiting
  • Instytut Pomnik - Centrum Zdrowia DzieckaRecruiting
  • Kazan State Medical University
  • Russian National Research Medical University named after N.I.Pirogov
  • FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences
  • Privolzhsky Research Medical University of Ministry of Health of Russian Federation
  • Saratov State Medical University
  • Yaroslavl Regional Children's Clinical Hospital
  • Birmingham Children's HospitalRecruiting
  • University Hospitals Bristol and Weston NHS Foundation TrustRecruiting
  • Cambridge University Hospitals NHS Foundation TrustRecruiting
  • Royal London HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Induction Period (I): Ustekinumab

Maintenance (M) Period: Ustekinumab once every 8 Week (q8w)

Maintenance (M) Period: Ustekinumab once every 12 Week (q12w)

Arm Description

All participants will receive a single intravenous (IV) administration of ustekinumab at induction Week 0 (I-0) based on body surface area (BSA) (milligram per meter square [mg/m^2]) or weight-tiered induction dose (milligram per kilogram [mg/kg]).

Participants will receive subcutaneous (SC) administration of ustekinumab every 8 weeks (q8w) based on BSA (mg/m^2) or weight-tiered induction dose (mg/kg) at Weeks M-0, M-8, M-16, M-24, M-32, M-40 and matching placebo at Weeks M-12 and M-36 to maintain the blind.

Participants will receive SC administration of ustekinumab every 12 weeks (q12w) based on BSA (mg/m^2) or weight-tiered induction dose (mg/kg) at Weeks M-0, M-12, M-24, M-36 and matching placebo at Weeks M-8, M-16, M-32, and M-40 to maintain the blind.

Outcomes

Primary Outcome Measures

Global: Number of Participants with Clinical Remission at Induction Week 8 (I-8) Visit
Clinical remission is defined as Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
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) as a Measure of Safety and Tolerability
SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product.
Number of Participants with AEs Leading to Discontinuation of Study Intervention
Number of Participants with discontinuation of study intervention due to an AE, infections, injection-site reactions, and AEs during or within 1 hour of an infusion will be reported.
Number of Participants with AEs of Special Interest (AESI) as a Measure of Safety and Tolerability
AESI of any newly identified malignancy, case of active tuberculosis (TB), or opportunistic infection occurring after the first administration of study intervention(s) in participants will be reported.
Number of Participants with Laboratory Abnormalities
Number of participants with laboratory abnormalities related to hematology, serum chemistry, and coagulation will be reported.
Reactions Temporally Associated with an Intravenous (IV) Infusion and Subcutaneous (SC) Injection-site Reactions
Reactions temporally associated with an IV infusion (induction period) and SC injection-site reactions (maintenance period) will be reported.
Serum Concentration of Ustekinumab
Serum samples will be analyzed to determine concentrations of ustekinumab.
US Specific: Clinical Remission at M-44 for Participants who are in Clinical Response at I-8
Clinical remission at M-44 for participants who are in clinical response at I-8 will be reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.

Secondary Outcome Measures

Number of Participants With Clinical Response at I-8 Visit
Clinical response is defined as decrease from baseline in the modified Mayo score by >= 30 percent (%) and >=2 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1.
Number of Participants with Symptomatic Remission at I-8 Visit
Symptomatic remission is defined as Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.
Clinical Remission at I-8 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score
Clinical remission is defined as a PUCAI score less than (<)10.
Endoscopic Improvement at I-8 Visit
Endoscopic improvement is defined as a Mayo endoscopy subscore of 0 or <= 1 with no friability present on the endoscopy.
Histologic-endoscopic Mucosal Improvement at Week I-8
Histologic-endoscopic mucosal improvement is defined as achieving a combination of histologic (neutrophil infiltration in less than [<] 5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system) and endoscopic improvement (endoscopy subscore of 0 or 1 with no friability present on the endoscopy).
Number of Participants with Clinical Remission at Week 44 (M-44) Visit
Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
Number of Participants with Symptomatic Remission at M-44 Visit
Symptomatic remission is defined as Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.
Clinical Remission at M-44 as Assessed by the PUCAI Score
Clinical remission is defined as a PUCAI score less than < 10.
Endoscopic Improvement at M-44 Visit
Endoscopic improvement is defined as a Mayo endoscopy subscore of 0 or <= 1 with no friability present on the endoscopy.
Corticosteroid-free Clinical Remission at Week M-44
Corticosteroid-free clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline; and not receiving corticosteroids for at least 90 days prior to Week M-44.
Clinical Remission at M-44 and not Receiving Corticosteroids for at Least 90 Days Prior to M-44 Among Participants who Received Corticosteroids at M-0
Clinical remission is defined as a PUCAI score less than < 10. Clinical remission at M-44 and in participants not receiving corticosteroids for at least 90 days prior to M-44 among participants who received corticosteroids at M-0 as assessed by PUCAI score will be reported.
Clinical Remission at M-44 for Participants who are in Clinical Remission at I-8
Clinical remission at M-44 for participants who are in clinical remission at I-8 will be reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
US Specific: Number of Participants with Clinical Remission at I-8 Visit
Clinical remission is defined as Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
Histologic-endoscopic Mucosal Improvement at Week M-44
Histologic-endoscopic mucosal improvement is defined as achieving a combination of histologic (neutrophil infiltration in < 5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system) and endoscopic improvement (endoscopy subscore of 0 or 1 with no friability present on the endoscopy).

Full Information

First Posted
November 13, 2020
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04630028
Brief Title
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Acronym
UNIFI Jr
Official Title
A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
July 24, 2025 (Anticipated)
Study Completion Date
July 25, 2025 (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
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics [PK]) in pediatric participants with moderately to severely active UC.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Induction Period (I): Ustekinumab
Arm Type
Experimental
Arm Description
All participants will receive a single intravenous (IV) administration of ustekinumab at induction Week 0 (I-0) based on body surface area (BSA) (milligram per meter square [mg/m^2]) or weight-tiered induction dose (milligram per kilogram [mg/kg]).
Arm Title
Maintenance (M) Period: Ustekinumab once every 8 Week (q8w)
Arm Type
Experimental
Arm Description
Participants will receive subcutaneous (SC) administration of ustekinumab every 8 weeks (q8w) based on BSA (mg/m^2) or weight-tiered induction dose (mg/kg) at Weeks M-0, M-8, M-16, M-24, M-32, M-40 and matching placebo at Weeks M-12 and M-36 to maintain the blind.
Arm Title
Maintenance (M) Period: Ustekinumab once every 12 Week (q12w)
Arm Type
Experimental
Arm Description
Participants will receive SC administration of ustekinumab every 12 weeks (q12w) based on BSA (mg/m^2) or weight-tiered induction dose (mg/kg) at Weeks M-0, M-12, M-24, M-36 and matching placebo at Weeks M-8, M-16, M-32, and M-40 to maintain the blind.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab Dose Based on BSA and Body Weight
Other Intervention Name(s)
STELARA
Intervention Description
As per BSA and body weight Ustekinumab will be administered SC and IV.
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Placebo will be administered subcutaneously.
Primary Outcome Measure Information:
Title
Global: Number of Participants with Clinical Remission at Induction Week 8 (I-8) Visit
Description
Clinical remission is defined as Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
Time Frame
Week 8
Title
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
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 74 weeks
Title
Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Description
SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product.
Time Frame
Up to 74 weeks
Title
Number of Participants with AEs Leading to Discontinuation of Study Intervention
Description
Number of Participants with discontinuation of study intervention due to an AE, infections, injection-site reactions, and AEs during or within 1 hour of an infusion will be reported.
Time Frame
Up to 74 weeks
Title
Number of Participants with AEs of Special Interest (AESI) as a Measure of Safety and Tolerability
Description
AESI of any newly identified malignancy, case of active tuberculosis (TB), or opportunistic infection occurring after the first administration of study intervention(s) in participants will be reported.
Time Frame
Up to 74 weeks
Title
Number of Participants with Laboratory Abnormalities
Description
Number of participants with laboratory abnormalities related to hematology, serum chemistry, and coagulation will be reported.
Time Frame
Up to 74 weeks
Title
Reactions Temporally Associated with an Intravenous (IV) Infusion and Subcutaneous (SC) Injection-site Reactions
Description
Reactions temporally associated with an IV infusion (induction period) and SC injection-site reactions (maintenance period) will be reported.
Time Frame
Up to 74 weeks
Title
Serum Concentration of Ustekinumab
Description
Serum samples will be analyzed to determine concentrations of ustekinumab.
Time Frame
Up to 74 weeks
Title
US Specific: Clinical Remission at M-44 for Participants who are in Clinical Response at I-8
Description
Clinical remission at M-44 for participants who are in clinical response at I-8 will be reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Number of Participants With Clinical Response at I-8 Visit
Description
Clinical response is defined as decrease from baseline in the modified Mayo score by >= 30 percent (%) and >=2 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1.
Time Frame
Week 8
Title
Number of Participants with Symptomatic Remission at I-8 Visit
Description
Symptomatic remission is defined as Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.
Time Frame
Week 8
Title
Clinical Remission at I-8 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score
Description
Clinical remission is defined as a PUCAI score less than (<)10.
Time Frame
Week 8
Title
Endoscopic Improvement at I-8 Visit
Description
Endoscopic improvement is defined as a Mayo endoscopy subscore of 0 or <= 1 with no friability present on the endoscopy.
Time Frame
Week 8
Title
Histologic-endoscopic Mucosal Improvement at Week I-8
Description
Histologic-endoscopic mucosal improvement is defined as achieving a combination of histologic (neutrophil infiltration in less than [<] 5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system) and endoscopic improvement (endoscopy subscore of 0 or 1 with no friability present on the endoscopy).
Time Frame
Week 8
Title
Number of Participants with Clinical Remission at Week 44 (M-44) Visit
Description
Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
Time Frame
Week 52
Title
Number of Participants with Symptomatic Remission at M-44 Visit
Description
Symptomatic remission is defined as Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.
Time Frame
Week 52
Title
Clinical Remission at M-44 as Assessed by the PUCAI Score
Description
Clinical remission is defined as a PUCAI score less than < 10.
Time Frame
Week 52
Title
Endoscopic Improvement at M-44 Visit
Description
Endoscopic improvement is defined as a Mayo endoscopy subscore of 0 or <= 1 with no friability present on the endoscopy.
Time Frame
Week 52
Title
Corticosteroid-free Clinical Remission at Week M-44
Description
Corticosteroid-free clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline; and not receiving corticosteroids for at least 90 days prior to Week M-44.
Time Frame
Week 52
Title
Clinical Remission at M-44 and not Receiving Corticosteroids for at Least 90 Days Prior to M-44 Among Participants who Received Corticosteroids at M-0
Description
Clinical remission is defined as a PUCAI score less than < 10. Clinical remission at M-44 and in participants not receiving corticosteroids for at least 90 days prior to M-44 among participants who received corticosteroids at M-0 as assessed by PUCAI score will be reported.
Time Frame
Week 52
Title
Clinical Remission at M-44 for Participants who are in Clinical Remission at I-8
Description
Clinical remission at M-44 for participants who are in clinical remission at I-8 will be reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
Time Frame
Week 52
Title
US Specific: Number of Participants with Clinical Remission at I-8 Visit
Description
Clinical remission is defined as Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
Time Frame
Week 8
Title
Histologic-endoscopic Mucosal Improvement at Week M-44
Description
Histologic-endoscopic mucosal improvement is defined as achieving a combination of histologic (neutrophil infiltration in < 5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system) and endoscopic improvement (endoscopy subscore of 0 or 1 with no friability present on the endoscopy).
Time Frame
Week 52

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: Medically stable on the basis of physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator Must have had UC diagnosed prior to screening Have moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with a screening Mayo endoscopy subscore greater than or equal to (>=) 2 as determined by a central review of the video of the endoscopy A participant who has had extensive colitis for >= 8 years, or disease limited to the left side of the colon for >= 10 years, must: a) have had a full colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study intervention or b) have a full colonoscopy with surveillance for dysplasia as the baseline endoscopy during the screening period. Results from these surveillance biopsies must be negative for dysplasia (low-grade, high-grade, or indeterminant) prior to the first administration of study intervention Females of childbearing potential must have a negative highly sensitive urine pregnancy test at screening and at Week I-0 prior to study intervention administration Exclusion Criteria: Have UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon Presence or history of colonic or small bowel obstruction within 6 months prior to screening, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy) Have a history of latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to screening Presence or history of any malignancy including presence or history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (example, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas) and monoclonal gammopathy of undetermined significance, or clinically significant hepatomegaly or splenomegaly Has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients
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
Nemours DuPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Center for Digestive Health Care
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Individual Site Status
Recruiting
Facility Name
Levine Children's at Atrium Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Penn State Hershey Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Name
Cook Childrens Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Name
Pediatric Specialists Of Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Universitair Kinderziekenhuis Koningin Fabiola
City
Brussel
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussel
ZIP/Postal Code
1200
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 Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charite-Universitätsmedizin Berlin - Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Completed
Facility Name
Dr. von Haunersches Kinderspital
City
Munich
ZIP/Postal Code
80337
Country
Germany
Individual Site Status
Recruiting
Facility Name
KUNO Klinik St. Hedwig
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Ulm
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Individual Site Status
Completed
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 Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Szegedi Tudományegyetem, Gyermekgyógyászati Klinika és Gyermekegészségügyi Centrum
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Shamir Medical Center (Assaf Harofeh)
City
Be'er Ya'akov
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Individual Site Status
Recruiting
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Name
Schneider Children's Medical Center
City
Petah Tikva
ZIP/Postal Code
4920235
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
30700
Country
Israel
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
Kindai University Nara Hospital
City
Ikoma
ZIP/Postal Code
630-0293
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kurume University Hospital
City
Kurume
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Children's Medical Center
City
Saitama-shi
ZIP/Postal Code
330-8777
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
Jichi Medical University Hospital
City
Shimotsuke
ZIP/Postal Code
329-0498
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mie University Hospital
City
Tsu
ZIP/Postal Code
514-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
Szpital im. M. Kopernika
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Individual Site Status
Completed
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
GASTROMED Sp. z o.o.
City
Torun
ZIP/Postal Code
87-100
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 Dziecka
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Individual Site Status
Recruiting
Facility Name
Kazan State Medical University
City
Kazan
ZIP/Postal Code
420138
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Russian National Research Medical University named after N.I.Pirogov
City
Moscow
ZIP/Postal Code
119571
Country
Russian Federation
Individual Site Status
Completed
Facility Name
FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Privolzhsky Research Medical University of Ministry of Health of Russian Federation
City
Nizhny Novgorod
ZIP/Postal Code
603950
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Saratov State Medical University
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Yaroslavl Regional Children's Clinical Hospital
City
Yaroslavl
ZIP/Postal Code
150032
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Birmingham Children's Hospital
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospitals Bristol and Weston NHS Foundation Trust
City
Bristol
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal London Hospital
City
London
ZIP/Postal Code
E1 2AT
Country
United Kingdom
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 Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)

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