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

Last Updated   April 24, 2024 - 21:04

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OVERVIEW

  • Gender
    all
  • Age
    2 - 17 years
  • Phase
    phase 3
    The 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
    24 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

Locations in:
United States, Turkey, Poland, Japan, Italy, Denmark, China, Belgium
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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