Colitis, Ulcerative
Conditions
Interventions
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.
Open-label Indu
Sponsors
Nakama Takahiro
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 |
|---|---|
| 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. | — |
Secondary
| Measure | 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. 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 (=) 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 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. 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. 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 | — |
Countries
Australia, Belgium, Canada, China, Denmark, Finland, France, Greece, Italy, Japan, Norway, Poland, Portugal, Spain, Sweden, Turkey, United States
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed