Colitis, Ulcerative
Conditions
Brief 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.
Interventions
Guselkumab will be administered subcutaneously.
DRUGGuselkumab Intravenous
Guselkumab will be administered intravenously.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Clinical Remission at Week 56 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| European Union: Percentage of Participants with Endoscopic Healing at Week 12 | 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. |
| Percentage of Participants with Clinical Response at Week 56 | 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. |
| Percentage of Participants With PUCAI Remission at Week 56 | 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. |
| Percentage of Participants with Symptomatic Remission at Week 56 | 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. |
| Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12 | Week 56 | 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. |
| United States: Percentage of Participants With Endoscopic Improvement at Week 56 | 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. |
| European Union: Percentage of Participants With Endoscopic Healing at Week 56 | 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. |
| Percentage of Participants Who Achieve Endoscopic Normalization at Week 56 | Week 56 | Percentage of participants who achieve endoscopic normalization with an endoscopy subscore of 0 at Week 56 will be reported. |
| Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56 | 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). |
| Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56 | 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 |
| Serum Concentration of Guselkumab During Induction Phase | From Week 0 to Week 12 | Serum samples will be analyzed to determine concentrations of guselkumab overtime. |
| Serum Concentration of Guselkumab During Maintenance Phase | From Week 12 to Week 56 | Serum samples will be analyzed to determine concentrations of guselkumab over time. |
| Number of Participants with Incidence of Anti-guselkumab Antibodies | Up to Week 68 | Number of participants with anti-guselkumab antibodies for all study treatment regimens will be assessed. |
| Percentage of Participants with Adverse Events (AEs) | Up to Week 68 | 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. |
| Percentage of Participants with Serious Adverse Events (SAEs) | Up to Week 68 | 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. |
| Percentage of Participants with AEs Leading to Discontinuation of Study Intervention | Up to Week 68 | Percentage of participants with AEs leading to discontinuation of study intervention will be reported. |
| Percentage of Participants with Symptomatic Remission at Week 12 | 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. |
| Percentage of Participants with Clinical Response at Week 12 | 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. |
| Percentage of Participants with Clinical Remission at Week 12 | 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. |
| United States: Percentage of Participants with Endoscopic Improvement at Week 12 | 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. |
| Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12 | 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. |
Countries
Australia, Belgium, China, Denmark, France, Italy, Japan, Norway, Poland, Portugal, Spain, Turkey (Türkiye), United States
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed