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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06260163
Other study ID # CR109251
Secondary ID 2022-001285-35CN
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 19, 2024
Est. completion date August 14, 2028

Study information

Verified date June 2024
Source Janssen Research & Development, LLC
Contact Study Contact
Phone 844-434-4210
Email Participate-In-This-Study@its.jnj.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date August 14, 2028
Est. primary completion date May 22, 2028
Accepts healthy volunteers No
Gender All
Age group 2 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Guselkumab Subcutaneous
Guselkumab will be administered subcutaneously.
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.
Guselkumab Intravenous
Guselkumab will be administered intravenously.

Locations

Country Name City State
Australia Perth Children's Hospital Nedlands
Belgium UZ Gent Gent
Belgium UZ Brussel Jette
Belgium UZ Leuven Leuven
China Capital Institute of Pediatrics Beijing
China Peking University Third Hospital Beijing
China Changzhou No 2 Peoples Hospital Changzhou City
China Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou
China The Childrens Hospital Zhejiang University School Of Medicine Hangzhou
China Ruijin Hospital Shanghai Jiao Tong University Shanghai
China Shengjing Hospital Of China Medical University Shenyang
China Henan Children's Hospital, Zhengzhou Children's Hospital ZhengZhou
Denmark Aarhus Universitetshospital Aarhus N
Denmark Hvidovre Hospital Hvidovre
France Hospices Civils de Lyon - Groupement Hospitalier Est - Hôpital Femme Mère Enfant Bron cedex
France Hopital Francois Mitterand Dijon
France CHRU Lille Lille Cedex
France APHP Hopital Robert Debre Paris
Italy AOU Meyer Firenze
Italy AOU Policlinico Umberto I Roma
Italy Casa Sollievo della Sofferenza San Giovanni Rotondo
Italy IRCCS Materno Infantile Burlo Garofolo Trieste
Japan Tokyo Metropolitan Children's Medical Center Fuchu
Japan Kanazawa University Hospital Kanazawa
Japan Kobe University Hospital Kobe
Japan Japanese Red Cross Kumamoto Hospital Kumamoto
Japan Shinshu University Hospital Matsumoto
Japan Saga University Hospital Saga
Japan Tokyo Medical University Hospital Shinjuku
Japan Osaka Medical and Pharmaceutical University Hospital Takatsuki
Japan Saiseikai Yokohamashi Tobu Hospital Yokohama
Poland Korczowski Bartosz Gabinet Lekarski Rzeszow
Poland Instytut Pomnik Centrum Zdrowia Dziecka Warszawa
Poland Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus Warszawa
Portugal Chp - Centro Materno Infantil Do Norte Porto
Portugal Chsj - Hosp. Sao Joao Porto
Spain Hosp. Infantil Univ. Nino Jesus Madrid
Spain Corporacio Sanitari Parc Tauli Sabadell
Spain Hosp. Univ. I Politecni La Fe València
Turkey Ankara University Medical Faculty Ankara
Turkey Gazi University Medical Faculty Ankara
Turkey Istanbul University Cerrahpasa Medical Faculty Istanbul
United States Riley Hospital for Children Indianapolis Indiana
United States NYU Langone Long Island Clinical Research Associates Lake Success New York

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  China,  Denmark,  France,  Italy,  Japan,  Poland,  Portugal,  Spain,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Serum Concentration of Guselkumab During Induction Phase Serum samples will be analyzed to determine concentrations of guselkumab overtime. From Week 0 to Week 12
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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