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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06260163




Registration number
NCT06260163
Ethics application status
Date submitted
7/02/2024
Date registered
15/02/2024

Titles & IDs
Public title
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Scientific title
A Phase 3 Randomized, Open-label Induction, Double-blind Maintenance, Parallel-group, Multicenter Protocol to Evaluate the Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2022-001285-35
Secondary ID [2] 0 0
CR109251
Universal Trial Number (UTN)
Trial acronym
QUASAR Jr
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Guselkumab Subcutaneous
Treatment: Drugs - Guselkumab Intravenous

Experimental: Open-label Induction Phase: Guselkumab Intravenously (IV) - Participants will receive a guselkumab dose IV based on their body weight (BW) during the 12-week open-label induction phase.

Experimental: Open-label Induction Phase: Guselkumab Subcutaneously (SC) - Participants will receive a guselkumab dose SC based on their BW during the 12-week open-label induction phase.

Experimental: Double-blind Maintenance Phase: Guselkumab Dose Regimen 1 - At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their BW up to Week 56.

Experimental: Double-blind Maintenance Phase: Guselkumab Dose Regimen 2 - At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their BW up to Week 56.

Experimental: Open-label Maintenance Phase: Guselkumab SC - Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 56.


Treatment: Drugs: Guselkumab Subcutaneous
Guselkumab will be administered subcutaneously.

Treatment: Drugs: Guselkumab Intravenous
Guselkumab will be administered intravenously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Clinical Remission at Week 56
Timepoint [1] 0 0
Week 56
Secondary outcome [1] 0 0
Percentage of Participants with Clinical Response at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants with Clinical Remission at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants with Symptomatic Remission at Week 12
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
United States: Percentage of Participants with Endoscopic Improvement at Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
European Union: Percentage of Participants with Endoscopic Healing at Week 12
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Percentage of Participants with Clinical Response at Week 56
Timepoint [7] 0 0
Week 56
Secondary outcome [8] 0 0
Percentage of Participants With PUCAI Remission at Week 56
Timepoint [8] 0 0
Week 56
Secondary outcome [9] 0 0
Percentage of Participants with Symptomatic Remission at Week 56
Timepoint [9] 0 0
Week 56
Secondary outcome [10] 0 0
Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12
Timepoint [10] 0 0
Week 56
Secondary outcome [11] 0 0
United States: Percentage of Participants With Endoscopic Improvement at Week 56
Timepoint [11] 0 0
Week 56
Secondary outcome [12] 0 0
European Union: Percentage of Participants With Endoscopic Healing at Week 56
Timepoint [12] 0 0
Week 56
Secondary outcome [13] 0 0
Percentage of Participants Who Achieve Endoscopic Normalization at Week 56
Timepoint [13] 0 0
Week 56
Secondary outcome [14] 0 0
Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56
Timepoint [14] 0 0
Week 56
Secondary outcome [15] 0 0
Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56
Timepoint [15] 0 0
Week 56
Secondary outcome [16] 0 0
Serum Concentration of Guselkumab During Induction Phase
Timepoint [16] 0 0
From Week 0 to Week 12
Secondary outcome [17] 0 0
Serum Concentration of Guselkumab During Maintenance Phase
Timepoint [17] 0 0
From Week 12 to Week 56
Secondary outcome [18] 0 0
Number of Participants with Incidence of Anti-guselkumab Antibodies
Timepoint [18] 0 0
Up to Week 68
Secondary outcome [19] 0 0
Percentage of Participants with Adverse Events (AEs)
Timepoint [19] 0 0
Up to Week 68
Secondary outcome [20] 0 0
Percentage of Participants with Serious Adverse Events (SAEs)
Timepoint [20] 0 0
Up to Week 68
Secondary outcome [21] 0 0
Percentage of Participants with AEs Leading to Discontinuation of Study Intervention
Timepoint [21] 0 0
Up to Week 68

Eligibility
Key inclusion criteria
* Weight greater than or equal to (>=) 10 kilogram (kg) at the time of consent for screening
* A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC.
* Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore >= 2 as determined by a central review of the video of the endoscopy
* Medically stable based on 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
* Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have UC limited to the rectum only or to less than (<) 20 centimeter of the colon
* Presence of a stoma
* Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline
* Have severe colitis or have evidence of Crohn's Disease (CD)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/08/2028
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Perth Children's Hospital - Nedlands
Recruitment hospital [2] 0 0
Mater Hospital Brisbane Inflammatory Bowel Diseases - South Brisbane
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Indiana
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
Belgium
State/province [3] 0 0
Charleroi
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Belgium
State/province [5] 0 0
Jette
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
China
State/province [7] 0 0
Beijing
Country [8] 0 0
China
State/province [8] 0 0
Changzhou City
Country [9] 0 0
China
State/province [9] 0 0
Hangzhou
Country [10] 0 0
China
State/province [10] 0 0
Shanghai
Country [11] 0 0
China
State/province [11] 0 0
Shenyang
Country [12] 0 0
China
State/province [12] 0 0
ZhengZhou
Country [13] 0 0
Denmark
State/province [13] 0 0
Aarhus N
Country [14] 0 0
Denmark
State/province [14] 0 0
Hvidovre
Country [15] 0 0
France
State/province [15] 0 0
Bron cedex
Country [16] 0 0
France
State/province [16] 0 0
Dijon
Country [17] 0 0
France
State/province [17] 0 0
Lille Cedex
Country [18] 0 0
France
State/province [18] 0 0
Paris
Country [19] 0 0
France
State/province [19] 0 0
Toulouse
Country [20] 0 0
Italy
State/province [20] 0 0
Bologna
Country [21] 0 0
Italy
State/province [21] 0 0
Firenze
Country [22] 0 0
Italy
State/province [22] 0 0
Roma
Country [23] 0 0
Italy
State/province [23] 0 0
San Giovanni Rotondo
Country [24] 0 0
Italy
State/province [24] 0 0
Trieste
Country [25] 0 0
Japan
State/province [25] 0 0
Fuchu
Country [26] 0 0
Japan
State/province [26] 0 0
Kanazawa
Country [27] 0 0
Japan
State/province [27] 0 0
Kobe
Country [28] 0 0
Japan
State/province [28] 0 0
Kumamoto
Country [29] 0 0
Japan
State/province [29] 0 0
Matsumoto
Country [30] 0 0
Japan
State/province [30] 0 0
Saga
Country [31] 0 0
Japan
State/province [31] 0 0
Shinjuku
Country [32] 0 0
Japan
State/province [32] 0 0
Takatsuki
Country [33] 0 0
Japan
State/province [33] 0 0
Yokohama
Country [34] 0 0
Poland
State/province [34] 0 0
Rzeszow
Country [35] 0 0
Poland
State/province [35] 0 0
Warszawa
Country [36] 0 0
Portugal
State/province [36] 0 0
Lisboa
Country [37] 0 0
Portugal
State/province [37] 0 0
Porto
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Spain
State/province [39] 0 0
Sabadell
Country [40] 0 0
Spain
State/province [40] 0 0
València
Country [41] 0 0
Turkey
State/province [41] 0 0
Ankara
Country [42] 0 0
Turkey
State/province [42] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06260163