A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (QUASAR Jr)
Last Updated   April 24, 2024 - 21:04
OVERVIEW
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Gender
all -
Age
years -
Phase
phase 3The drug or treatment is given to large groups of people to confirm its effectiveness, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. -
Sites
sites -
Status
Recruiting
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.
CONDITIONS
- Colitis, Ulcerative
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)
DETAILS
LOCATIONS
Country (8) | City or Province (24) | Status |
United States | Indianapolis, IN Riley Hospital for Children |
RECRUITING
|
Turkey | Ankara Gazi University Medical Faculty |
RECRUITING
|
Poland | Rzeszow Korczowski Bartosz Gabinet Lekarski |
RECRUITING
|
Poland | Warszawa Instytut Pomnik Centrum Zdrowia Dziecka |
RECRUITING
|
Poland | Warszawa Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus |
RECRUITING
|
Japan | Kanazawa Kanazawa University Hospital |
RECRUITING
|
Japan | Kobe, 28 Kobe University Hospital |
RECRUITING
|
Japan | Kumamoto, 43 Japanese Red Cross Kumamoto Hospital |
RECRUITING
|
Japan | Matsumoto Shinshu University Hospital |
RECRUITING
|
Japan | Saga, 41 Saga University Hospital |
RECRUITING
|
Japan | Shinjuku, 13 Tokyo Medical University Hospital |
RECRUITING
|
Japan | Takatsuki, 27 Osaka Medical and Pharmaceutical University Hospital |
RECRUITING
|
Japan | Yokohama, 14 Saiseikai Yokohamashi Tobu Hospital |
RECRUITING
|
Italy | Roma AOU Policlinico Umberto I |
RECRUITING
|
Denmark | Hvidovre Hvidovre Hospital |
RECRUITING
|
China | Beijing, 11 Capital Institute of Pediatrics |
RECRUITING
|
China | Beijing, 11 Peking University Third Hospital |
RECRUITING
|
China | Changzhou City Changzhou No 2 Peoples Hospital |
RECRUITING
|
China | Hangzhou Sir Run Run Shaw Hospital, Zhejiang University School of Medicine |
RECRUITING
|
China | Hangzhou The Childrens Hospital Zhejiang University School Of Medicine |
RECRUITING
|
China | Shanghai, 31 Ruijin Hospital, Shanghai Jiao Tong University |
RECRUITING
|
China | Shenyang Shengjing Hospital of China Medical University |
RECRUITING
|
Belgium | Gent UZ Gent |
RECRUITING
|
Belgium | Jette, BRU UZ Brussel |
RECRUITING
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Corresponds to individual site.