Eine Studie zu Guselkumab bei pädiatrischen Teilnehmern mit mittelschwerer bis schwerer aktiver Colitis ulcerosa (QUASAR Jr)
Ein randomisiertes, offenes Induktions-, Doppelblind-Erhaltungs-, Parallelgruppen-, Multicenter-Protokoll der Phase 3 zur Bewertung der Wirksamkeit, Sicherheit und Pharmakokinetik von Guselkumab bei pädiatrischen Teilnehmern mit mittelschwerer bis schwerer aktiver Colitis ulcerosa
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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Nedlands, Australien, 6009
- The Kids Research Institute Australia on behalf of the Centre for Child Health Research
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South Brisbane, Australien, 4101
- Mater Hospital Brisbane Inflammatory Bowel Diseases
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Westmead, Australien, 2145
- The Children's Hospital at Westmead
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Charleroi, Belgien, 6042
- CHU Charleroi Chimay
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Ghent, Belgien, 9000
- UZ Gent
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Jette, Belgien, 1090
- UZ Brussel
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Leuven, Belgien, 3000
- UZ Leuven
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Beijing, China, 100191
- Peking University Third Hospital
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Beijing, China, 100020
- Capital Center For Children's health Capital Medical University
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Changzhou, China, 213004
- Changzhou No 2 Peoples Hospital
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Hangzhou, China, 310016
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Hangzhou, China, 310005
- The Childrens Hospital Zhejiang University School Of Medicine
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Shanghai, China, 200025
- Ruijin Hospital Shanghai Jiao Tong University
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Shenyang, China, 110055
- Shengjing Hospital Of China Medical University
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Zhengzhou, China, 450052
- Henan Children's Hospital, Zhengzhou Children's Hospital
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Aarhus N, Dänemark, 8200
- Aarhus Universitetshospital
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Hvidovre, Dänemark, 2650
- Hvidovre Hospital
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Bron, Frankreich, 69677
- Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
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Dijon, Frankreich, 21000
- Hopital Francois Mitterand
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Lille, Frankreich, 59037
- CHRU Lille
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Paris, Frankreich, 75019
- APHP Hopital Robert Debre
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Toulouse, Frankreich, 31059
- CHU Toulouse
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Bergamo, Italien, 24127
- ASST Papa Giovanni XXIII Bergamo
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Bologna, Italien, 40133
- Azienda USL di Bologna - Ospedale Maggiore
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Florence, Italien, 50139
- AOU Meyer
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Pescara, Italien, 65124
- Ospedale S. Spirito, Azienda Sanitaria Pescara
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Roma, Italien, 00161
- AOU Policlinico Umberto I
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Roma, Italien, 00165
- IRCCS Ospedale Pediatrico Bambino Gesu
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San Giovanni Rotondo, Italien, 71013
- Casa Sollievo della Sofferenza
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Trieste, Italien, 34137
- IRCCS Materno Infantile Burlo Garofolo
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Fuchū, Japan, 183 8561
- Tokyo Metropolitan Children's Medical Center
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Kanazawa, Japan, 920 8641
- Kanazawa University Hospital
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Kobe, Japan, 650 0017
- Kobe University Hospital
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Kumamoto, Japan, 861 8520
- Japanese Red Cross Kumamoto Hospital
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Matsumoto, Japan, 390 8621
- Shinshu University Hospital
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Saga, Japan, 849-8501
- Saga University Hospital
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Setagaya Ku, Japan, 157 8535
- National Center for Child Health and Development
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Shinjuku, Japan, 160 0023
- Tokyo Medical University Hospital
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Takatsuki, Japan, 569-8686
- Osaka Medical and Pharmaceutical University Hospital
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Yokohama, Japan, 230-8765
- Saiseikai Yokohamashi Tobu Hospital
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Lørenskog, Norwegen, 1478
- Akershus Universitetssykehus
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Oslo, Norwegen, 0450
- Oslo University Hospital
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Tromsø, Norwegen, 9030
- Universitetssykehuset Nord-Norge HF
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Trondheim, Norwegen, 7030
- St. Olavs Hospital
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Gdansk, Polen, 80 803
- Copernicus Podmiot Leczniczy Sp. z o.o
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Rzeszów, Polen, 35-302
- Korczowski Bartosz Gabinet Lekarski
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Warsaw, Polen, 04 501
- Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
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Warsaw, Polen, 04 730
- Instytut Pomnik Centrum Zdrowia Dziecka
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Lisbon, Portugal, 1649-035
- Uls Santa Maria - Hosp. Santa Maria
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Porto, Portugal, 4200 319
- Uls Sao Joao - Hosp. Sao Joao
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Porto, Portugal, 4050-651
- Uls Santo Antonio - Cmin
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Madrid, Spanien, 28009
- Hosp. Infantil Univ. Nino Jesus
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Sabadell, Spanien, 08028
- Corporacio Sanitari Parc Tauli
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Valencia, Spanien, 46026
- Hosp. Univ. I Politecni La Fe
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Ankara, Türkei (türkiye), 06560
- Gazi University Medical Faculty
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Ankara, Türkei (türkiye), 6620
- Ankara University Medical Faculty
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Istanbul, Türkei (türkiye), 34899
- Marmara University Pendik Training Hospital
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Istanbul, Türkei (türkiye), 34098
- Istanbul University Cerrahpasa Medical Faculty
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California
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Oakland, California, Vereinigte Staaten, 94609
- Children's Hospital Oakland
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Indiana
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Indianapolis, Indiana, Vereinigte Staaten, 46202
- Riley Hospital for Children
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New York
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Lake Success, New York, Vereinigte Staaten, 11042
- NYU Langone Health
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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.
Andere Namen:
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Experimental: 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.
Andere Namen:
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Experimental: 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.
Andere Namen:
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Experimental: 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.
Andere Namen:
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Experimental: 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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Percentage of Participants with Clinical Remission at Week 56
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Percentage of Participants with Clinical Response at Week 12
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Week 56
|
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Week 56
|
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
Zeitfenster: 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
Zeitfenster: 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 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Week 56
|
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
Zeitfenster: 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
Zeitfenster: 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
|
|
Number of Participants with Incidence of Anti-guselkumab Antibodies
Zeitfenster: Up to Week 68
|
Number of participants with anti-guselkumab antibodies for all study treatment regimens will be assessed. |
Up to Week 68
|
|
Percentage of Participants with Adverse Events (AEs)
Zeitfenster: 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
|
|
Percentage of Participants with Serious Adverse Events (SAEs)
Zeitfenster: Up to Week 68
|
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
|
|
Percentage of Participants with AEs Leading to Discontinuation of Study Intervention
Zeitfenster: Up to Week 68
|
Percentage of participants with AEs leading to discontinuation of study intervention will be reported. |
Up to Week 68
|
Mitarbeiter und Ermittler
Ermittler
- Studienleiter: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CR109251
- 2022-001285-35 (EudraCT-Nummer)
- CNTO1959PUC3001 (Andere Kennung: Janssen Research & Development, LLC)
- 2022-502238-22-00 (Registrierungskennung: EUCT number)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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