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

Last Updated   April 29, 2025

Want to learn how to participate in this trial?

CR109251

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    2+ years
  • Phase
    phase 3
    3
  • Sites
    58 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
* 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)


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 p

More...

DETAILS

LOCATIONS

Locations in:
United States, Belgium, China, Denmark, France, Italy, Japan, Poland, Spain, Türkiye, Australia, Norway, Portugal
Country (13) City or Province (58) Status
United States Indianapolis Riley Hospital for Children
RECRUITING
Belgium Charleroi CHU Charleroi Chimay
RECRUITING
Belgium Gent UZ Gent
RECRUITING
Belgium Jette UZ Brussel
RECRUITING
Belgium Leuven UZ Leuven
RECRUITING
China Beijing Capital Institute of Pediatrics
RECRUITING
China Beijing Peking University Third Hospital
RECRUITING
China Changzhou City Changzhou No 2 Peoples Hospital
RECRUITING
China Hangzhou The Childrens Hospital Zhejiang University School Of Medicine
RECRUITING
China Shanghai Ruijin Hospital Shanghai Jiao Tong University
RECRUITING
China Shenyang Shengjing Hospital Of China Medical University
RECRUITING
China ZhengZhou Henan Children's Hospital, Zhengzhou Children's Hospital
RECRUITING
Denmark Aarhus N Aarhus Universitetshospital
RECRUITING
Denmark Hvidovre Hvidovre Hospital
RECRUITING
France Dijon Hopital Francois Mitterand
RECRUITING
France Lille Cedex CHRU Lille
RECRUITING
France Paris APHP Hopital Robert Debre
RECRUITING
Italy Bologna Azienda USL di Bologna - Ospedale Maggiore
RECRUITING
Italy Firenze AOU Meyer
RECRUITING
Italy Roma AOU Policlinico Umberto I
RECRUITING
Italy San Giovanni Rotondo Casa Sollievo della Sofferenza
RECRUITING
Italy Trieste IRCCS Materno Infantile Burlo Garofolo
RECRUITING
Japan Saga Saga University Hospital
RECRUITING
Japan Shinjuku Tokyo Medical University Hospital
RECRUITING
Japan Takatsuki Osaka Medical and Pharmaceutical University Hospital
RECRUITING
Japan Yokohama Saiseikai Yokohamashi Tobu Hospital
RECRUITING
Poland Rzeszow Korczowski Bartosz Gabinet Lekarski
RECRUITING
Poland Warszawa Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
RECRUITING
Poland Warszawa Instytut Pomnik Centrum Zdrowia Dziecka
RECRUITING
Spain Madrid Hosp. Infantil Univ. Nino Jesus
RECRUITING
Spain Sabadell Corporacio Sanitari Parc Tauli
RECRUITING
Spain València Hosp. Univ. I Politecni La Fe
RECRUITING
Türkiye Ankara Gazi University Medical Faculty
RECRUITING
Türkiye Ankara Ankara University Medical Faculty
RECRUITING
Türkiye Istanbul Istanbul University Cerrahpasa Medical Faculty
RECRUITING
Japan Fuchu Tokyo Metropolitan Children's Medical Center
RECRUITING
Japan Kobe Kobe University Hospital
RECRUITING
Japan Kumamoto Japanese Red Cross Kumamoto Hospital
RECRUITING
United States Lake Success NYU Langone Health
RECRUITING
Australia Nedlands The Kids Research Institute Australia on behalf of the Centre for Child Health Research
RECRUITING
Australia South Brisbane Mater Hospital Brisbane Inflammatory Bowel Diseases
RECRUITING
Australia Westmead The Children's Hospital at Westmead
RECRUITING
China Hangzhou Sir Run Run Shaw Hospital Zhejiang University School of Medicine
RECRUITING
France Bron cedex Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
RECRUITING
France Toulouse CHU Toulouse
RECRUITING
Italy Pescara Ospedale S. Spirito, Azienda Sanitaria Pescara
RECRUITING
Italy Roma IRCCS Ospedale Pediatrico Bambino Gesu
RECRUITING
Japan Kanazawa Kanazawa University Hospital
RECRUITING
Japan Matsumoto Shinshu University Hospital
RECRUITING
Japan Setagaya Ku National Center for Child Health and Development
RECRUITING
Norway Lørenskog Akershus Universitetssykehus
RECRUITING
Norway Oslo Oslo University Hospital
RECRUITING
Norway Tromso Universitetssykehuset Nord-Norge HF
RECRUITING
Norway Trondheim St. Olavs Hospital
RECRUITING
Portugal Lisboa Uls Santa Maria - Hosp. Santa Maria
RECRUITING
Portugal Porto Uls Santo Antonio - Cmin
RECRUITING
Portugal Porto Uls Sao Joao - Hosp. Sao Joao
RECRUITING
Türkiye Istanbul Marmara University Pendik Training Hospital
RECRUITING
Show More
Geo Locations

39.76838, -86.15804

50.41136, 4.44448

51.05, 3.71667

50.87309, 4.33419

50.87959, 4.70093

39.9075, 116.39723

39.9075, 116.39723

31.7610799, 119.97121

30.29365, 120.16142

31.22222, 121.45806

41.79222, 123.43278

34.75778, 113.64861

56.15674, 10.21076

55.65719, 12.47364

47.31667, 5.01667

50.63297, 3.05858

48.85341, 2.3488

44.49381, 11.33875

43.77925, 11.24626

41.89193, 12.51133

41.70643, 15.7277

45.64953, 13.77679

33.23333, 130.3

35.2946, 139.57059

34.84833, 135.61678

35.43333, 139.65

50.04132, 21.99901

52.22977, 21.01178

52.22977, 21.01178

40.4165, -3.70256

41.54329, 2.10942

39.46975, -0.37739

39.91987, 32.85427

39.91987, 32.85427

41.01384, 28.94966

35.6916008, 139.4620917

34.6913, 135.183

32.80589, 130.69182

40.77066, -73.71763

-31.98184, 115.8073

-27.48034, 153.02049

-33.80383, 150.98768

30.29365, 120.16142

45.73333, 4.91667

43.60426, 1.44367

42.4584, 14.20283

41.89193, 12.51133

36.6, 136.61667

36.23333, 137.96667

35.64825, 139.65376

59.92625, 10.95422

59.91273, 10.74609

69.6489, 18.95508

63.43049, 10.39506

38.71667, -9.13333

41.14961, -8.61099

41.14961, -8.61099

41.01384, 28.94966

x
50

Indicates 50+ sites in this region: click to zoom in.

10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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