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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959PUC3001 | Other Identifier | Janssen Research & Development, LLC | |
| 2022-001285-35 | EudraCT Number | ||
| 2022-502238-22-00 | Registry Identifier | EUCT number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label Induction Phase: Guselkumab Intravenously (IV) | Experimental | Participants will receive a guselkumab dose IV based on their body weight (BW) during the 12-week open-label induction phase. |
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| Open-label Induction Phase: Guselkumab Subcutaneously (SC) | Experimental | Participants will receive a guselkumab dose SC based on their BW during the 12-week open-label induction phase. |
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| Double-blind Maintenance Phase: Guselkumab Dose Regimen 1 | Experimental | 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. |
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| Double-blind Maintenance Phase: Guselkumab Dose Regimen 2 | Experimental | 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. |
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| Open-label Maintenance Phase: Guselkumab SC | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab Subcutaneous | Drug | Guselkumab will be administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Clinical Remission at Week 56 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Clinical Response at Week 12 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Oakland | Oakland | California | 94609 | United States | ||
| Riley Hospital for Children |
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
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| Guselkumab Intravenous | Drug | Guselkumab will be administered intravenously. |
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| Week 12 |
| Percentage of Participants with Clinical Remission at Week 12 | 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 |
| Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12 | 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 |
| Percentage of Participants with Symptomatic Remission at Week 12 | 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 |
| United States: Percentage of Participants with Endoscopic Improvement at Week 12 | 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 |
| European Union: Percentage of Participants with Endoscopic Healing at Week 12 | 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 |
| Percentage of Participants with Clinical Response at 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 |
| Percentage of Participants With PUCAI Remission at Week 56 | 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 |
| Percentage of Participants with Symptomatic Remission at Week 56 | 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 |
| Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12 | 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 |
| United States: Percentage of Participants With Endoscopic Improvement at Week 56 | 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 |
| European Union: Percentage of Participants With Endoscopic Healing at 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 |
| Percentage of Participants Who Achieve Endoscopic Normalization at Week 56 | Percentage of participants who achieve endoscopic normalization with an endoscopy subscore of 0 at Week 56 will be reported. | Week 56 |
| Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56 | 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 |
| Percentage of Participants with Corticosteroid-free Clinical Remission at 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 |
| Serum Concentration of Guselkumab During Induction Phase | Serum samples will be analyzed to determine concentrations of guselkumab overtime. | From Week 0 to Week 12 |
| Serum Concentration of Guselkumab During Maintenance Phase | 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 | 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) | 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) | 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 | Percentage of participants with AEs leading to discontinuation of study intervention will be reported. | Up to Week 68 |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| NYU Langone Health | Lake Success | New York | 11042 | United States |
| The Kids Research Institute Australia on behalf of the Centre for Child Health Research | Nedlands | 6009 | Australia |
| Mater Hospital Brisbane Inflammatory Bowel Diseases | South Brisbane | 4101 | Australia |
| The Children's Hospital at Westmead | Westmead | 2145 | Australia |
| CHU Charleroi Chimay | Charleroi | 6042 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Brussel | Jette | 1090 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Capital Center For Children's health Capital Medical University | Beijing | 100020 | China |
| Peking University Third Hospital | Beijing | 100191 | China |
| Changzhou No 2 Peoples Hospital | Changzhou | 213004 | China |
| The Childrens Hospital Zhejiang University School Of Medicine | Hangzhou | 310005 | China |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | 310016 | China |
| Ruijin Hospital Shanghai Jiao Tong University | Shanghai | 200025 | China |
| Shengjing Hospital Of China Medical University | Shenyang | 110004 | China |
| Henan Children's Hospital, Zhengzhou Children's Hospital | Zhengzhou | 450052 | China |
| Aarhus Universitetshospital | Aarhus N | 8200 | Denmark |
| Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant | Bron | 69677 | France |
| Hopital Francois Mitterand | Dijon | 21000 | France |
| CHRU Lille | Lille | 59037 | France |
| APHP Hopital Robert Debre | Paris | 75019 | France |
| CHU Toulouse | Toulouse | 31059 | France |
| ASST Papa Giovanni XXIII Bergamo | Bergamo | 24127 | Italy |
| Azienda USL di Bologna - Ospedale Maggiore | Bologna | 40133 | Italy |
| AOU Meyer | Florence | 50139 | Italy |
| Ospedale S. Spirito, Azienda Sanitaria Pescara | Pescara | 65124 | Italy |
| AOU Policlinico Umberto I | Roma | 00161 | Italy |
| IRCCS Ospedale Pediatrico Bambino Gesu | Roma | 00165 | Italy |
| Casa Sollievo della Sofferenza | San Giovanni Rotondo | 71013 | Italy |
| IRCCS Materno Infantile Burlo Garofolo | Trieste | 34137 | Italy |
| Tokyo Metropolitan Children's Medical Center | Fuchū | 183 8561 | Japan |
| Kanazawa University Hospital | Kanazawa | 920 8641 | Japan |
| Kobe University Hospital | Kobe | 650 0017 | Japan |
| Japanese Red Cross Kumamoto Hospital | Kumamoto | 861 8520 | Japan |
| Shinshu University Hospital | Matsumoto | 390 8621 | Japan |
| Saga University Hospital | Saga | 849-8501 | Japan |
| National Center for Child Health and Development | Setagaya Ku | 157 8535 | Japan |
| Tokyo Medical University Hospital | Shinjuku | 160 0023 | Japan |
| Osaka Medical and Pharmaceutical University Hospital | Takatsuki | 569-8686 | Japan |
| Saiseikai Yokohamashi Tobu Hospital | Yokohama | 230-8765 | Japan |
| Akershus Universitetssykehus | Lørenskog | 1478 | Norway |
| Oslo University Hospital | Oslo | 0450 | Norway |
| Universitetssykehuset Nord-Norge HF | Tromsø | 9030 | Norway |
| St. Olavs Hospital | Trondheim | 7030 | Norway |
| Copernicus Podmiot Leczniczy Sp. z o.o | Gdansk | 80 803 | Poland |
| Korczowski Bartosz Gabinet Lekarski | Rzeszów | 35-302 | Poland |
| Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus | Warsaw | 04 501 | Poland |
| Instytut Pomnik Centrum Zdrowia Dziecka | Warsaw | 04 730 | Poland |
| Uls Santa Maria - Hosp. Santa Maria | Lisbon | 1649-035 | Portugal |
| Uls Santo Antonio - Cmin | Porto | 4050-651 | Portugal |
| Uls Sao Joao - Hosp. Sao Joao | Porto | 4200 319 | Portugal |
| Hosp. Infantil Univ. Nino Jesus | Madrid | 28009 | Spain |
| Corporacio Sanitari Parc Tauli | Sabadell | 08028 | Spain |
| Hosp. Univ. I Politecni La Fe | Valencia | 46026 | Spain |
| Gazi University Medical Faculty | Ankara | 06560 | Turkey (Türkiye) |
| Ankara University Medical Faculty | Ankara | 6620 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Medical Faculty | Istanbul | 34098 | Turkey (Türkiye) |
| Marmara University Pendik Training Hospital | Istanbul | 34899 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000588857 | guselkumab |
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