A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (QUASAR Jr)

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

The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.

Study Overview

• Status: Recruiting
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Drug: Matching Placebo; Drug: Guselkumab Intravenous; Drug: Guselkumab Subcutaneous

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Recruiting
    • UZ Gent
  • Jette, Belgium, 1090
    • Recruiting
    • UZ Brussel
• China
  • Beijing, China, 100191
    • Recruiting
    • Peking University Third Hospital
  • Beijing, China, 100020
    • Recruiting
    • Capital Institute of Pediatrics
  • Changzhou City, China, 213004
    • Recruiting
    • Changzhou No 2 Peoples Hospital
  • Hangzhou, China, 310016
    • Recruiting
    • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  • Hangzhou, China, 310005
    • Recruiting
    • The Childrens Hospital Zhejiang University School Of Medicine
  • Shanghai, China, 200025
    • Recruiting
    • Ruijin Hospital, Shanghai Jiao Tong University
  • Shenyang, China, 110004
    • Recruiting
    • Shengjing Hospital of China Medical University
• Denmark
  • Hvidovre, Denmark, 2650
    • Recruiting
    • Hvidovre Hospital
• Italy
  • Roma, Italy, 00161
    • Recruiting
    • AOU Policlinico Umberto I
• Japan
  • Kanazawa, Japan, 920-8641
    • Recruiting
    • Kanazawa University Hospital
  • Kobe, Japan, 650-0017
    • Recruiting
    • Kobe University Hospital
  • Kumamoto, Japan, 861-8520
    • Recruiting
    • Japanese Red Cross Kumamoto Hospital
  • Matsumoto, Japan, 390-8621
    • Recruiting
    • Shinshu University Hospital
  • Saga, Japan, 849-8501
    • Recruiting
    • Saga University Hospital
  • Shinjuku, Japan, 160-0023
    • Recruiting
    • Tokyo Medical University Hospital
  • Takatsuki, Japan, 569-8686
    • Recruiting
    • Osaka Medical and Pharmaceutical University Hospital
  • Yokohama, Japan, 230-8765
    • Recruiting
    • Saiseikai Yokohamashi Tobu Hospital
• Poland
  • Rzeszow, Poland, 35-302
    • Recruiting
    • Korczowski Bartosz Gabinet Lekarski
  • Warszawa, Poland, 04 501
    • Recruiting
    • Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
  • Warszawa, Poland, 04 730
    • Recruiting
    • Instytut Pomnik Centrum Zdrowia Dziecka
• Turkey
  • Ankara, Turkey, 06560
    • Recruiting
    • Gazi University Medical Faculty
• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Riley Hospital for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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, and a baseline Mayo rectal bleeding subscore >=1
• 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
• Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Guselkumab Intravenous; Guselkumab will be administered intravenously.; Other Names: CNTO1959; TREMFYA
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.	Drug: Guselkumab Subcutaneous; Guselkumab will be administered subcutaneously.; Other Names: CNTO1959; TREMFYA
Experimental: Double-blind Maintenance Phase: Guselkumab SC or Guselkumab SC and Placebo SC; At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive a guselkumab dose SC based on their BW or a guselkumab dose SC based on their BW and placebo SC up to Week 56.	Drug: Matching Placebo; Week 12 induction responders will be administered placebo (matching guselkumab up to Week 56) SC at protocol specified time points to maintain the blind.; Drug: Guselkumab Subcutaneous; Guselkumab will be administered subcutaneously.; Other Names: CNTO1959; TREMFYA
Experimental: Open-label Maintenance Phase: Guselkumab SC; Week 12 non-responders will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 56.	Drug: Guselkumab Subcutaneous; Guselkumab will be administered subcutaneously.; Other Names: CNTO1959; TREMFYA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Clinical Remission at Week 56	Percentage of participants with clinical remission as assessed by modified Mayo score at Week 56 among participants who were induction responders will be reported. Clinical remission per modified Mayo score is defined as a 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.	Week 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Clinical Remission at Week 12	Percentage of participants with clinical remission at Week 12 as assessed by modified Mayo score will be reported. Clinical remission per modified Mayo score is defined as a 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.	Week 12
Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12	Percentage of participants with PUCAI remission at Week 12 will be reported. It comprises 6 scales and ranges between 0 and 85 points. The scales are abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (<) 10 indicates remission.	Week 12
Percentage of Participants with Symptomatic Remission at Week 12	Percentage of participants with symptomatic remission at Week 12 will be reported. Symptomatic remission is defined as a 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.	Week 12
United States: Percentage of Participants with Endoscopic Improvement at Week 12	Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.	Week 12
European Union: Percentage of Participants with Endoscopic Healing at Week 12	Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.	Week 12
Percentage of Participants with Clinical Response at Week 12	Percentage of participants with clinical response as assessed by modified Mayo score at Week 12 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A decrease from baseline in the modified Mayo score by greater than or equal to (>=) 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.	Week 12
Percentage of Participants with Symptomatic Remission at Week 56	Percentage of participants with symptomatic remission at Week 56 will be reported. Symptomatic remission is defined as a 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.	Week 56
United States: Percentage of Participants With Endoscopic Improvement at Week 56	Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.	Week 56
European Union: Percentage of Participants With Endoscopic Healing at Week 56	Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.	Week 56
Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56	Percentage of participants with corticosteroid-free clinical remission at Week 56 will be reported. 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 (Week 0), and not receiving corticosteroids for at least 8 weeks prior to Week 56	Week 56
Percentage of Participants with Clinical Response at Week 56	Percentage of participants with clinical response as assessed by modified Mayo score at Week 56 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A 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.	Week 56
Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56	Percentage of participants histo-endoscopic mucosal healing per endoscopy subscore and histologic improvement at Week 56 will be reported. Histologic-endoscopic mucosal healing is defined as achieving a combination of histologic improvement and endoscopic improvement (US) or endoscopic healing (EU) (endoscopy subscore of 0 or 1).	Week 56
Percentage of Participants Who Achieve Endoscopic Normalization at Week 56	Percentage of participants who achieve endoscopic normalization with an endoscopy subscore of 0 at Week 56 will be reported.	Week 56
Percentage of Participants With PUCAI Remission at Week 56	Percentage of participants with PUCAI remission at Week 56 will be reported. PUCAI comprises of 6 scales and ranges between 0 and 85 points. The scales are: abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (<) 10 indicates remission.	Week 56
Serum Concentration of Guselkumab During Induction Phase	Serum samples will be analyzed to determine concentrations of guselkumab overtime.	From Week 0 to Week 12
Serum Concentration of Guselkumab During Maintenance Phase	Serum samples will be analyzed to determine concentrations of guselkumab over time.	From Week 12 to Week 56
Number of Participants with Incidence of Anti-guselkumab Antibodies	Number of participants with anti-guselkumab antibodies for all study treatment regimens will be assessed.	Up to Week 68
Percentage of Participants with Adverse Events (AEs)	Percentage of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.	Up to Week 68
Percentage of Participants with Serious Adverse Events (SAEs)	Percentage of participants with SAEs will be reported. An 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 or incapacity; congenital anomaly.	Up to Week 68
Percentage of Participants with AEs Leading to Discontinuation of Study Intervention	Percentage of participants with AEs leading to discontinuation of study intervention will be reported.	Up to Week 68
Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12	Percentage of participants with symptomatic remission at Week 56 among participants who had symptomatic remission at Week 12 will be reported. Symptomatic remission score is defined as a 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.	Week 56

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2024
• Primary Completion (Estimated): May 22, 2028
• Study Completion (Estimated): August 14, 2028

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: CR109251; 2022-001285-35 (EudraCT Number); CNTO1959PUC3001 (Other Identifier: Janssen Research & Development, LLC); 2022-502238-22-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No