Studie Guselkumabu u pediatrických účastníků se středně těžkou až těžkou aktivní ulcerózní kolitidou (QUASAR Jr)
Randomizovaná, otevřená indukce fáze 3, dvojitě zaslepená údržba, paralelní skupina, multicentrický protokol k vyhodnocení účinnosti, bezpečnosti a farmakokinetiky guselkumabu u pediatrických účastníků se středně těžkou až těžkou aktivní ulcerózní kolitidou
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Nedlands, Austrálie, 6009
- The Kids Research Institute Australia on behalf of the Centre for Child Health Research
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South Brisbane, Austrálie, 4101
- Mater Hospital Brisbane Inflammatory Bowel Diseases
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Westmead, Austrálie, 2145
- The Children's Hospital at Westmead
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Charleroi, Belgie, 6042
- CHU Charleroi Chimay
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Ghent, Belgie, 9000
- UZ Gent
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Jette, Belgie, 1090
- UZ Brussel
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Leuven, Belgie, 3000
- UZ Leuven
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Aarhus N, Dánsko, 8200
- Aarhus Universitetshospital
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Hvidovre, Dánsko, 2650
- Hvidovre Hospital
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Bron, Francie, 69677
- Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
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Dijon, Francie, 21000
- Hopital Francois Mitterand
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Lille, Francie, 59037
- CHRU Lille
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Paris, Francie, 75019
- APHP Hopital Robert Debre
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Toulouse, Francie, 31059
- CHU Toulouse
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Bergamo, Itálie, 24127
- ASST Papa Giovanni XXIII Bergamo
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Bologna, Itálie, 40133
- Azienda USL di Bologna - Ospedale Maggiore
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Florence, Itálie, 50139
- AOU Meyer
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Pescara, Itálie, 65124
- Ospedale S. Spirito, Azienda Sanitaria Pescara
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Roma, Itálie, 00161
- AOU Policlinico Umberto I
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Roma, Itálie, 00165
- IRCCS Ospedale Pediatrico Bambino Gesu
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San Giovanni Rotondo, Itálie, 71013
- Casa Sollievo della Sofferenza
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Trieste, Itálie, 34137
- IRCCS Materno Infantile Burlo Garofolo
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Fuchū, Japonsko, 183 8561
- Tokyo Metropolitan Children's Medical Center
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Kanazawa, Japonsko, 920 8641
- Kanazawa University Hospital
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Kobe, Japonsko, 650 0017
- Kobe University Hospital
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Kumamoto, Japonsko, 861 8520
- Japanese Red Cross Kumamoto Hospital
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Matsumoto, Japonsko, 390 8621
- Shinshu University Hospital
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Saga, Japonsko, 849-8501
- Saga University Hospital
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Setagaya Ku, Japonsko, 157 8535
- National Center for Child Health and Development
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Shinjuku, Japonsko, 160 0023
- Tokyo Medical University Hospital
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Takatsuki, Japonsko, 569-8686
- Osaka Medical and Pharmaceutical University Hospital
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Yokohama, Japonsko, 230-8765
- Saiseikai Yokohamashi Tobu Hospital
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Lørenskog, Norsko, 1478
- Akershus Universitetssykehus
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Oslo, Norsko, 0450
- Oslo University Hospital
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Tromsø, Norsko, 9030
- Universitetssykehuset Nord-Norge HF
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Trondheim, Norsko, 7030
- St. Olavs Hospital
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Gdansk, Polsko, 80 803
- Copernicus Podmiot Leczniczy Sp. z o.o
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Rzeszów, Polsko, 35-302
- Korczowski Bartosz Gabinet Lekarski
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Warsaw, Polsko, 04 501
- Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
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Warsaw, Polsko, 04 730
- Instytut Pomnik Centrum Zdrowia Dziecka
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Lisbon, Portugalsko, 1649-035
- Uls Santa Maria - Hosp. Santa Maria
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Porto, Portugalsko, 4200 319
- Uls Sao Joao - Hosp. Sao Joao
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Porto, Portugalsko, 4050-651
- Uls Santo Antonio - Cmin
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California
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Oakland, California, Spojené státy, 94609
- Children's Hospital Oakland
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Indiana
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Indianapolis, Indiana, Spojené státy, 46202
- Riley Hospital for Children
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New York
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Lake Success, New York, Spojené státy, 11042
- NYU Langone Health
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Ankara, Turecko (Türkiye), 06560
- Gazi University Medical Faculty
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Ankara, Turecko (Türkiye), 6620
- Ankara University Medical Faculty
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Istanbul, Turecko (Türkiye), 34899
- Marmara University Pendik Training Hospital
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Istanbul, Turecko (Türkiye), 34098
- Istanbul University Cerrahpasa Medical Faculty
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Beijing, Čína, 100191
- Peking University Third Hospital
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Beijing, Čína, 100020
- Capital Center For Children's health Capital Medical University
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Changzhou, Čína, 213004
- Changzhou No 2 Peoples Hospital
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Hangzhou, Čína, 310016
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Hangzhou, Čína, 310005
- The Childrens Hospital Zhejiang University School Of Medicine
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Shanghai, Čína, 200025
- Ruijin Hospital Shanghai Jiao Tong University
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Shenyang, Čína, 110055
- Shengjing Hospital Of China Medical University
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Zhengzhou, Čína, 450052
- Henan Children's Hospital, Zhengzhou Children's Hospital
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Madrid, Španělsko, 28009
- Hosp. Infantil Univ. Nino Jesus
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Sabadell, Španělsko, 08028
- Corporacio Sanitari Parc Tauli
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Valencia, Španělsko, 46026
- Hosp. Univ. I Politecni La Fe
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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. |
Guselkumab will be administered intravenously.
Ostatní jména:
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Experimentální: Open-label Induction Phase: Guselkumab Subcutaneously (SC)
Participants will receive a guselkumab dose SC based on their BW during the 12-week open-label induction phase. |
Guselkumab will be administered subcutaneously.
Ostatní jména:
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Experimentální: Double-blind Maintenance Phase: Guselkumab Dose Regimen 1
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their BW up to Week 56. |
Guselkumab will be administered subcutaneously.
Ostatní jména:
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Experimentální: Double-blind Maintenance Phase: Guselkumab Dose Regimen 2
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their BW up to Week 56. |
Guselkumab will be administered subcutaneously.
Ostatní jména:
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Experimentální: Open-label Maintenance Phase: Guselkumab SC
Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 56. |
Guselkumab will be administered subcutaneously.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Percentage of Participants with Clinical Remission at Week 56
Časové okno: Week 56
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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. |
Week 56
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants with Clinical Response at Week 12
Časové okno: Week 12
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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. |
Week 12
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Percentage of Participants with Clinical Remission at Week 12
Časové okno: Week 12
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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. |
Week 12
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Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12
Časové okno: Week 12
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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. |
Week 12
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Percentage of Participants with Symptomatic Remission at Week 12
Časové okno: Week 12
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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. |
Week 12
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United States: Percentage of Participants with Endoscopic Improvement at Week 12
Časové okno: Week 12
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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. |
Week 12
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European Union: Percentage of Participants with Endoscopic Healing at Week 12
Časové okno: Week 12
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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. |
Week 12
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Percentage of Participants with Clinical Response at Week 56
Časové okno: Week 56
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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. |
Week 56
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Percentage of Participants With PUCAI Remission at Week 56
Časové okno: Week 56
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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. |
Week 56
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Percentage of Participants with Symptomatic Remission at Week 56
Časové okno: Week 56
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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. |
Week 56
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Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12
Časové okno: Week 56
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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. |
Week 56
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United States: Percentage of Participants With Endoscopic Improvement at Week 56
Časové okno: Week 56
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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. |
Week 56
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European Union: Percentage of Participants With Endoscopic Healing at Week 56
Časové okno: Week 56
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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. |
Week 56
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Percentage of Participants Who Achieve Endoscopic Normalization at Week 56
Časové okno: Week 56
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Percentage of participants who achieve endoscopic normalization with an endoscopy subscore of 0 at Week 56 will be reported. |
Week 56
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Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56
Časové okno: Week 56
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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). |
Week 56
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Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56
Časové okno: Week 56
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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 |
Week 56
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Serum Concentration of Guselkumab During Induction Phase
Časové okno: From Week 0 to Week 12
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Serum samples will be analyzed to determine concentrations of guselkumab overtime. |
From Week 0 to Week 12
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Serum Concentration of Guselkumab During Maintenance Phase
Časové okno: From Week 12 to Week 56
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Serum samples will be analyzed to determine concentrations of guselkumab over time. |
From Week 12 to Week 56
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Number of Participants with Incidence of Anti-guselkumab Antibodies
Časové okno: Up to Week 68
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Number of participants with anti-guselkumab antibodies for all study treatment regimens will be assessed. |
Up to Week 68
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Percentage of Participants with Adverse Events (AEs)
Časové okno: 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. |
Up to Week 68
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Percentage of Participants with Serious Adverse Events (SAEs)
Časové okno: Up to Week 68
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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. |
Up to Week 68
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Percentage of Participants with AEs Leading to Discontinuation of Study Intervention
Časové okno: Up to Week 68
|
Percentage of participants with AEs leading to discontinuation of study intervention will be reported. |
Up to Week 68
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CR109251
- 2022-001285-35 (Číslo EudraCT)
- CNTO1959PUC3001 (Jiný identifikátor: Janssen Research & Development, LLC)
- 2022-502238-22-00 (Identifikátor registru: EUCT number)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
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