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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959PBCRD3007 | Other Identifier | Janssen Research & Development, LLC | |
| 2021-006282-37 | EudraCT Number | ||
| 2023-504735-41-00 | Registry Identifier | EUCT number |
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The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label induction phase: Guselkumab Intravenously (IV) | Experimental | Participants will receive guselkumab dose IV based on their body weight during the 12-week open-label induction phase. |
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| Open-label induction phase: Guselkumab Subcutaneously (SC) | Experimental | Participants will receive guselkumab dose SC based on their body weight during the 12-week open-label induction phase. |
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| Double-blind maintenance phase: Guselkumab SC 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 body weight up to Week 48. |
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| Double-blind Maintenance Phase: Guselkumab SC 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 body weight up to Week 48. |
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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 48. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Guselkumab will be administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Clinical Remission at Week 52 | Percentage of participants with clinical remission at Week 52 will be assessed. Clinical remission is defined as pediatric Crohn's Disease activity index (PCDAI) less than or equal to (<=) 10. | Week 52 |
| Percentage of Participants Who Achieve Endoscopic Response at Week 52 | Percentage of participants who achieve endoscopic response at Week 52 will be assessed. Endoscopic response is defined as greater than or equal to (>=) 50 percent (%) reduction (global) and greater than (>) 50% reduction (U.S specific) from simplified endoscopic score-Crohn's Disease (SES-CD) score at baseline. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Clinical Response at Week 12 | Percentage of participants with clinical response at Week 12 will be assessed. Clinical responder is defined as a decrease from baseline in the PCDAI score of >=12.5 points with a total PCDAI score <30. | Week 12 |
| Percentage of Participants with Clinical Response at Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States | |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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 | Drug | Guselkumab will be administered intravenously. |
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Percentage of participants with clinical response at Week 52 will be assessed. Clinical responder is defined as a decrease from baseline in the PCDAI score of >=12.5 points with a total PCDAI score <30. |
| Week 52 |
| Percentage of Participants with Clinical Remission at Week 12 | Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is defined as PCDAI score <=10. | Week 12 |
| Percentage of Participants with Endoscopic Remission at Week 52 | Percentage of participants with endoscopic remission at Week 52 will be assessed. Endoscopic remission is defined as SES-CD total score <=4 and at least a 2-point reduction from baseline and no subscore >1. | Week 52 |
| Percentage of Participants with Corticosteroid-free Remission at Week 52 | Percentage of participants with corticosteroid-free remission at Week 52 will be assessed. Corticosteroid-free remission is defined as PCDAI score <=10 at Week 52 and not receiving corticosteroids for at least 90 days before Week 52. | Week 52 |
| Percentage of Participants with Sustained Clinical Remission at Weeks 12, 24, and 52 | Percentage of participants with sustained clinical remission at Weeks 12, 24, and 52 will be assessed. Sustained clinical remission is defined as PCDAI <=10 at Weeks 12, 24, and 52. | Weeks 12, 24, and 52 |
| Percentage of Participants with Clinical remission by Patient-Reported Outcome (PRO-2) | Percentage of participants with clinical remission by PRO-2 will be assessed. Clinical remission by PRO-2 is defined as stool frequency (SF) <=3 and abdominal pain (AP) <=1 and no worsening of SF and AP from baseline. | Week 12 and/or Week 52 |
| Serum Concentration of Guselkumab During Induction Phase | Serum concentrations of guselkumab will be assessed. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive immunoassay method. | From Week 0 to Week 12 |
| Trough Plasma Concentration (Ctrough) of Guselkumab During Maintenance Phase | Ctrough is defined as the serum concentration of guselkumab immediately prior (pre-dose) to the next drug administration. | At Weeks 16, 24, 36, 48 and 52 |
| Change from Baseline in Body Weight at Weeks 12, 24, and 52 | Change from baseline in body weight at Weeks 12, 24, and 52 will be assessed. | Baseline, Weeks 12, 24, and 52 |
| Change from Baseline in Body Weight Percentiles at Weeks 12, 24, and 52 | Change from baseline in body weight percentiles at Weeks 12, 24, and 52 will be assessed. | Baseline, Weeks 12, 24, and 52 |
| Change from Baseline in Body Weight z-scores at Weeks 12, 24, and 52 | Change from baseline in body weight z-scores at Weeks 12, 24, and 52 will be assessed. | Baseline, Weeks 12, 24, and 52 |
| Change from Baseline in Height at Weeks 12, 24, and 52 | Change from baseline in height at Weeks 12, 24, and 52 will be assessed. | Baseline, Weeks 12, 24, and 52 |
| Change from Baseline in Height Percentiles at Weeks 12, 24, and 52 | Change from baseline in height percentiles at Weeks 12, 24, and 52 will be assessed. | Baseline, Weeks 12, 24, and 52 |
| Change from Baseline in Height z-scores at Weeks 12, 24, and 52 | Change from baseline in height z-scores at Weeks 12, 24, and 52 will be assessed. | Baseline, Weeks 12, 24, and 52 |
| Change from Baseline in Height Velocity at Weeks 12, 24, and 52 | Change from baseline in height velocity at Weeks 12, 24, and 52 will be assessed. | Baseline, Weeks 12, 24, and 52 |
| Percentage of Participants with Clinical Remission | Percentage of participants with clinical remission who were assigned to guselkumab dose regimen 1 and did not receive rescue therapy at Week 52 will be assessed. Clinical remission is defined as PCDAI score <=10. | Week 52 |
| Percentage of Participants Who Achieve Endoscopic Response | Percentage of participants who achieve endoscopic response who were assigned to q4w maintenance therapy and did not receive rescue therapy at Week 52 will be assessed. Endoscopic response is defined as >=50% reduction (global) and >50% reduction (U.S specific) from SES-CD score at baseline. | Week 52 |
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. An SAE is is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important. | Up to Week 64 |
| Connecticut Children's Medical Center |
| Recruiting |
| Hartford |
| Connecticut |
| 06106 |
| United States |
| Emory University | Active, not recruiting | Atlanta | Georgia | 30322 | United States |
| Children's Center for Digestive Health Care | Recruiting | Atlanta | Georgia | 30342 | United States |
| Riley Hospital for Children | Recruiting | Indianapolis | Indiana | 46202-5225 | United States |
| Boston Childrens Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| Goryeb Children's Hospital | Recruiting | Morristown | New Jersey | 07960 | United States |
| Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center | Recruiting | New York | New York | 10021-5663 | United States |
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
| Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
| The Children's Medical Center of Dayton | Completed | Dayton | Ohio | 45404 | United States |
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Cook Childrens Medical Center | Recruiting | Fort Worth | Texas | 76104 | United States |
| University of Vermont Medical Center | Recruiting | Colchester | Vermont | 05446 | United States |
| Perth Children's Hospital | Recruiting | Nedlands | 6009 | Australia |
| Mater Hospital Brisbane | Recruiting | South Brisbane | 4101 | Australia |
| The Children's Hospital at Westmead | Recruiting | Westmead | 2145 | Australia |
| AKH - Medizinische Universitat Wien | Recruiting | Vienna | 1090 | Austria |
| Universitair Ziekenhuis Brussel | Recruiting | Brussels | 1090 | Belgium |
| Cliniques Universitaires Saint Luc | Recruiting | Brussels | 1200 | Belgium |
| Universitair Ziekenhuis Gent | Recruiting | Ghent | 9000 | Belgium |
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
| Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro | Recruiting | Campinas | 13060-904 | Brazil |
| Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro | Recruiting | Curitiba | 80250-060 | Brazil |
| Universidade Federal de Goias - Hospital das Clinicas da UFG | Recruiting | Goiânia | 74605-020 | Brazil |
| Hospital De Clinicas De Porto Alegre | Recruiting | Porto Alegre | 90035-007 | Brazil |
| Irmandade Santa Casa de Misericordia de Porto Alegre | Recruiting | Porto Alegre | 90035-074 | Brazil |
| Centro de Ciencias e Saude da Universidade Federal do Espirito Santo-Nucleo de Doencas Infecciosas | Recruiting | Vitória | 29040-091 | Brazil |
| INTEGRAL Pesquisa e Ensino | Recruiting | Votuporanga | 100000 | Brazil |
| Iwk Health Centre | Recruiting | Halifax | Nova Scotia | B3K 6R8 | Canada |
| London Health Sciences Centre Victoria Hospital | Recruiting | London | Ontario | N6A 5W9 | Canada |
| Hospital For Sick Children | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
| CHU Amiens-Hopital Nord | Recruiting | Amiens | 80054 | France |
| Hôpital Jeanne de FLANDRE, CHRU LILLE | Recruiting | Lille | 59037 | France |
| Hôpital Necker - Enfants Malades | Recruiting | Paris | 75015 | France |
| Hôpital Robert Debré | Recruiting | Paris | 75019 | France |
| Soroka University Medical Center | Recruiting | Beersheba | 84101 | Israel |
| Shamir Medical Center Assaf Harofeh | Recruiting | Be’er Ya‘aqov | 70300 | Israel |
| Shaare Zedek Medical Center | Recruiting | Jerusalem | 9103102 | Israel |
| Hadassah Medical Center | Recruiting | Jerusalem | 9124001 | Israel |
| Schneider Children's Medical Center | Recruiting | Petah Tikva | 4920235 | Israel |
| Kaplan Medical Center | Recruiting | Rehovot | 761001 | Israel |
| A.O. Santi Antonio e Biagio e Cesare Arrigo | Recruiting | Alessandria | 15121 | Italy |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) | Recruiting | Bergamo | 24127 | Italy |
| Ospedale Bellaria, U.O.Cardiologia Az. USL di Bologna | Recruiting | Bologna | 40124 | Italy |
| Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer | Recruiting | Florence | 50139 | Italy |
| Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale dei Bambini Vittore Buzzi | Recruiting | Milan | 20154 | Italy |
| AOU Policlinico Umberto I | Recruiting | Roma | 161 | Italy |
| Hirosaki University Hospital | Recruiting | Hirosaki | 036-8563 | Japan |
| Kagoshima University Hospital | Recruiting | Kagoshima | 890-8544 | Japan |
| Tsujinaka Hospital Kashiwanoha | Recruiting | Kashiwa-shi | 277-0871 | Japan |
| Kobe University Hospital | Recruiting | Kobe | 650 0017 | Japan |
| Saga University Hospital | Recruiting | Saga | 849-8501 | Japan |
| Miyagi Childrens Hospital | Recruiting | Sendai | 989-3126 | Japan |
| National Center for Child Health and Development | Recruiting | Setagaya Ku | 157 8535 | Japan |
| Juntendo University Hospital | Recruiting | Tokyo | 113-8431 | Japan |
| Mie University Hospital | Recruiting | Tsu | 514 8507 | Japan |
| Yamaguchi University Hospital | Recruiting | Ube | 755-8505 | Japan |
| Saiseikai Yokohamashi Tobu Hospital | Recruiting | Yokohama | 230-8765 | Japan |
| Yokohama City University Medical Center | Recruiting | Yokohama | 232-0024 | Japan |
| Erasmus Medisch Centrum | Recruiting | Rotterdam | 3015 GD | Netherlands |
| Akershus Universitetssykehus HF | Recruiting | Nordbyhagen | 1474 | Norway |
| Oslo University Hospital | Recruiting | Oslo | 424 | Norway |
| Universitetssykehuset Nord-Norge HF | Recruiting | Tromsø | 9038 | Norway |
| St. Olavs Hospital | Recruiting | Trondheim | 7030 | Norway |
| Korczowski Bartosz Gabinet Lekarski | Recruiting | Rzeszów | 35-302 | Poland |
| WIP Warsaw IBD Point Profesor Kierkus | Recruiting | Warsaw | 04 501 | Poland |
| Instytut Pomnik Centrum Zdrowia | Recruiting | Warsaw | 04 730 | Poland |
| Hospital de Braga | Recruiting | Braga | 4710-243 | Portugal |
| Centro Hospitalar de Lisboa Norte Hospital Santa Maria | Recruiting | Lisbon | 1649-035 | Portugal |
| Centro Hospitalar de Sao Joao E.P.E. | Recruiting | Porto | 4200-319 | Portugal |
| Inje University Haeundae Paik Hospital | Recruiting | Busan | 48108 | South Korea |
| Kyungpook National University Chilgok Hospital | Recruiting | Daegu | 41404 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Severance Hospital Yonsei University Health System | Recruiting | Seoul | 120-752 | South Korea |
| Hosp Reina Sofia | Recruiting | Córdoba | 14004 | Spain |
| Corporacio Sanitari Parc Tauli | Recruiting | Sabadell | 8208 | Spain |
| Hosp. Univ. I Politecni La Fe | Recruiting | Valencia | 46026 | Spain |
| Royal Hospital for Sick Children | Recruiting | Glasgow | G51 4TF | United Kingdom |
| Great Ormond Street Hospital | Recruiting | London | WC1N 3JH | United Kingdom |
| Nowgen Centre, Research and Innovation | Recruiting | Manchester | M13 9WL | United Kingdom |
| Royal Manchester Children's Hospital | Recruiting | Manchester | M13 9WL | United Kingdom |
| John Radcliffe Hospital | Recruiting | Oxford | OX3 9DU | United Kingdom |
| Sheffield Children's Hospital | Recruiting | Sheffield | S10 2TH | United Kingdom |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000588857 | guselkumab |
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